(Hardcopies available for weblinks.)
Abraira C, Colwell J, Nuttall F, Sawin CT, Henderson W, Comstock JP, et al. Cardiovascular events and correlates in the Veterans Affairs diabetes feasibility trial: Veterans Affairs cooperative study on glycemic control and complications in type II diabetes. Arch Intern Med 1997 January 27;157:181-187.
Abraira C, Duckworth W, McCarren M, Emanuele N, Arca D, Reda D, et al. Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2: Vetrans Affairs Diabetes Tria. J. Diabetes Complications 2003 Nov-Dec;17(6):314-322.
Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC, Bigger JT, Buse JB, et al. Effects of intensive glucose lowering in type 2 diabetes. NEJM 2008 Jun 12;358(24):2545-2559.
Advanced Diabetes Treatment Center. Online at:
http://www.adtcusa.com/DOR.htm; and http://www.adtcusa.com/managementteam.html; and http://drnachlas.com/dr-nachlas.html; and http://www.ccs.fau.edu/~Tuller/publ.html; and http://www.adtcusa.com/departmentofresearch.html; and http://www.secinfo.com/d11Eeb.4f89d.b.htm
(See Diabetex. See SEC.)
Agency for Healthcare Research and Quality (AHRQ).
(The AHRQ does not have any guidelines that address the use of outpatient intravenous insulin therapy or the use of calorimetry in diabetic patients.)
AHRQ External Technology Assessments
i.Balk E, Teplinsky E, Trikalinos T, Chew P, Chung M, Lau J, Pittas A. Applicability of the Evidence Regarding Intensive Glycemic Control and Self-Monitored Blood Glucose to Medicare Patients with Type 2 Diabetes. September 10, 2007.
ii.Holohan TV. Simultaneous Pancreas-Kidney and Sequential Pancreas-After-Kidney Transplantation. August 1995.
iii.Hotta SS. Isolated Pancreas Transplantation. August 1995.
iv. Matchar DB, Keefe FJ, McCrory DC, Scipio CD, Cooper K, Kolimaga JT, Huntington AC. Use of Behavioral Therapies for Treatment of Medical Disorders Part 1 Impact on Management of Patients with Diabetes Mellitus. May 9, 2004.
v. Matchar DB, McCrory DC, Samsa GP, Lobaugh B, Liu K. Point of Care Testing of Hemoglobin A1c. August 30, 2005.
(See Cochran. See NICE.)
Aetna. Clinical Policy Bulletin: Intermittent Intravenous Insulin Therapy. Number: 0742. Online at: http://www.aetna.com/cpb/medical/data/700_799/0742.html
Agency for Healthcare Research and Quality. Effective Health Care: Comparative effectiveness and safety of oral diabetes medications for adults with type 2 diabetes. Executive Summary Number 8. Online at: http://effectivehealthcare.ahrq.gov/repFiles/OralExecutiveSummary.pdf
Agius L. Glucokinase and molecular aspects of liver glycogen metabolism. Biochem J 2008 Aug 15;414(1):1-18.
Agius L. New hepatic targets for glycaemic control in diabetes. Best Pract Res Clin Endocrinol Metab 2007 Dec;21(4):587-605.
Agius L. Targeting hepatic glucokinase in type 2 diabetes: Weighing the benefits and risks. Diabetes 2009 Jan;58(1):18-20.
Aguis L, Peak M, VanSchaftingen E. The regulatory protein of glucokinase binds to the hepatocyte matrix, but, unlike glucokinase, doses not translocate during substrate stimulation. Biochem J 1995 Aug 1;309 (Pt 3):711-713.
Alfonzo AV, Isles C, Geddes C, Deighan C. Potassium disorders-clinical spectrum and emergency management. Resuscitation 2006 Jul;70(1):10-25.
Allon M, Copkney C. Albuterol and insulin for treatment of hyperkalemia in hemodialysis patients. Kidney International 1990;38:869-872.
American Association of Clinical Endocrinologists (AACE)
(The AACE does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
AACE 9/2009 letter to CMS. (Hardcopy available.)
AACE Medical Guidelines for the Clinical Practice for the Management of Diabetes Mellitus. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. Chair HW. Rodbard, 2007.
American Association of Clinical Endocrinologists Medical Guidelines for the Clinical Use of Dietary Supplements and Nutraceuticals. AACE Nutrition Guidelines Task Force. Chair JL Mechanick, 2003.
American Association of Clinical Endocrinologists/American College of Endocrinology’s guidelines for the Management of DM Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus 2007;13(Suppl 1):1-66. Online at: http://www.aace.com/pub/pdf/guidelines/DMGuidelines2007.pdf
American Association for Respiratory Care (AARC)
(The AARC does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
AARC Clinical Practice Guideline: Metabolic measurement using indirect calorimetry during mechanical ventilation – 2004 revision & update. Respiratory Care 2004 September:49(9):1073-1079. Online at: http://www.rcjournal.com/cpgs/pdf/09.04.1073.pdf
American College of Cardiology (ACC)
(The ACC has guidelines for cardiac disease. The ACC does not have any guidelines that address use of the outpatient intravenous insulin therapeutic modality or the use of calorimetry in diabetic patients.)
American College of Chest Physicians (ACCP)
(The ACCP does not have any guidelines that address use of the outpatient intravenous insulin therapeutic modality or the use of calorimetry in diabetic patients.)
ACCP has guidelines for cardiovascular disease and the use of gas exchange devices as part of exercise tolerance testing.
American College of Chest Physicians (ACCP) and American Thoracic Society (ATS)
The ACCP/American Thoracic Society (ATS) has guidelines for cardiopulmonary disease and some aspects of nutrition.
ATS/ACCP Statement: Cardiopulmonary Exercise Testing (Corrected Version) [Original accepted by Society 11/1/01]. (The joint guidelines with the ATS address the importance of calibrating equipment and the use of the gas exchange devices as part of exercise tolerance testing.)
American College of Chest Physicians/American Thoracic Society/ (ACCP/ATS). Medically Unlikely Edit Letter July 30, 2009. (See CCI-Rosen. See Parrish.)
American College of Physicians (ACP) (The ACP does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
The ACP guidelines for diabetes.
Glycemic Control and Type 2 Diabetes Mellitus: The Optimal Hemoglobin A1c Targets. A Guidande Statement from the American College of Physicians 10/28/06. A Qaseem, S Vijan, V Snow, J Cross, K Weiss, D Owens for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians.
Guidelines on Lipid Control in Type 2 Diabetes 7/03. V Snow, M Aronson, E Hombake, C Mottur-Pilson, K Weiss for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians
Pharmacologic Lipid-Lowering Therapy in Type 2 Diabetes Mellitus: Background Paper for the American College of Physicians (evidence review) 4/20/2004.
American Diabetes Association. Diabetes Mellitus. What is the impact of diabetes? Online at: http://www.medicinenet.com/diabetes_mellitus/article.htm
American Diabetes Association (ADA). (The ADA has guidelines and publications about diabetes and diabetes management for both patients and professionals. The ADA does not have any guidelines that address use of outpatient intravenous insulin or the use of calorimetry in diabetic patients.)
All About Diabetes. Online at:
2008 American Diabetes Association Clinical Guidelines. Online at:
Summary of Revisions for the 2008 Clinical Practice Recommendations. Online at:
ADA Standards of Medical Care in Diabetes – 2009. Online at:
Executive Summary Standards of Medical Care in Diabetes – 2009. Online at:
Committee Reports and consensus Statements. Online at: http://care.diabetesjournals.org/content/32/Supplement_1/S96.full.pdf+html
Diabetes Care: Insulin Administration ADA Position Statement. Diabetes Care 2004 Jan;27 Suppl (1):S106-S109. Online at: http://care.diabetesjournals.org/content/27/suppl_1/s106.full.pdf+html
Hyperglycemic crises inpatients with diabetes mellitus. Diabetes Care 2003 January;26(1):S109-S117.
List of Position Statements. Online at: http://care.diabetesjournals.org/content/32/Supplement_1/S98.full.pdf+hrml
Nutrition Recommendations and interventions for diabetes: A position statement of the ADA. Online at:
Position Statement. Online at: http://care.diabetesjournals.org/content/32/Supplement_1/S98.full.pdf+html
Standards in Medical Care in Diabetes–2008. Online at:
Standards of Medical Care in Diabetes–2009. Diabetes Care Jan 2009. 32 Suppl (1):S13-S61. Online at:
Summary of Revisions for the 2009 Clinical Practice Recommendations. Online at: http://care.diabetesjournals.org/content/32/Supplement_1/S3.full.pdf+html
Treatment Guidelines Patient summary. Online at:
Position Statement: Unproven Therapies. Diabetes Care 2004 January;27 Suppl (1):S135.
ADA Richard Kahn, PhD expert comment on September 18, 2009 on Outpatient Intravenous Insulin Treatment. (Hardcopy available.)
The Practical Insulin – A Handbook for Prescribers. Online at:
Intensive Diabetes Management Updates, 4th Edition. Online at:
Practical insulin – A handbook for prescribers. 2002. Library of Congress Cataloging-in-Publication Data. United States of America. CMS copy (WK 39 P895 2002) on loan (July 2009) from the Baltimore Medical Center, 10 N. Green Street, Baltimore, MD 21201.
On Insulin Pumps. Online at:
Technical Reviews. Online at: http://care.diabetesjournals.org/content/32/Supplement_1/S95.full.pdf+html
Related Patient Materials
ADA Treatment Guidelines patient Summary. Online at:
About Insulin and other Drugs – ADA. Online at:
Diabetes Statistics. Online at:
American Dietetic Association (ADA)
(The ADA does not have any guidelines that address use of outpatient intravenous insulin or the use of outpatient calorimetry in diabetic patients.)
The ADA guidelines for nutrition in diabetic patients
ADA Diabetes Type 1 and 2 Evidence-based Nutrition Practice Guideline for Adults 2006 GET. Online at:
The ADA guideline for nutrition during critical illness
(The guideline discusses metabolic cart measurements in the hospital setting.) Online at:
American Geriatric Society (AGS)
(The AGS does not have any guidelines that address use of intravenous insulin or the use of calorimetry in diabetic patients.)
AGA guidelines for diabetes care
Guidelines for Improving the Care of the Older Person with Diabetes Mellitus-2003. California Healthcare Foundation/American Geriatrics Society Panel on Improving Care for Elders with Diabetes. Online at:
Guidelines for improving the care of the older person with diabetes mellitus: California Healthcare Foundation/American Geriatrics Society Panel on improving care for elders with diabetes. JAGS 2003;51(5)(Suppl 1):S265-S280. Online at: http://www.americangeriatrics.org/products/positionpapers/JAGSfinal05.pdf
American Heart Association (AHA)
(The AHA does not have any guidelines that address use of intravenous insulin or the use of calorimetry in diabetic patients.)
The AHA guideline for clinical exercise testing
Guidelines for Clinical Exercise Testing Laboratories-1995. IL Pina, GJ Balady, P Hanson, AJ Labovitz, DW Madonna, J Myers. Online at:
The AHA Joint Scientific Statement with the American Diabetes Association
Primary Prevention of Cardiovascular Diseases in People with Diabetes Mellitus-2006. JB Buse, HN ginsberg, GL Bakris, NG Clark, F Costa, R Eckel, V Fonseca, HC Gerstein, S Grundy, RW Nesto, MP Pignone, J Plutzky, D Porte, R Redberg, KF Stitzel, NJ Stone. Online at:
American Medical Association (AMA)
Current Procedural Terminology (CPT) 2008: Professional Edition 2008.
Current Procedural Terminology Assistant: Your practical guide to current coding. Pulmonary Function Testing. Jan 1999. 9;(1). Online at: http://reimbursement.respironics.com/downloads/pulmon.pdf
Physician Resources/Solutions. Managing your practice coding/billing-insurance/cpt/applying cpt codes. Online at:
Resource-Based Relative Value Scale (RBRVS) Update Committee. Online at:
American Medical Association (AMA) or the Centers for Medicare and Medicaid Services (CMS). Requests for new codes. Submit to:
American Society of Consultant Pharmacists. Change in Medicare policy on reimbursement for fingerstick blood glucose tests in nursing facility residents. Federal Register. 71 FR 69624 Final Rule. Department of Health and Human Services. 2006 Dec 1; 42 CFR Parts 405, 410, 411, 414, 415 and 424. Proposed Rule CMS-1321-FC. Online at: http://www.clinicalreimbursement.com/MyFiles/PDF/Blood glucose 11_06.pdf
American Thoracic Society (ATS)
(The ATS does not have any guidelines that address use of the outpatient intravenous insulin therapeutic modality or the use of calorimetry in diabetic patients.)
The ATS guidelines for cardiopulmonary disease and some aspects of nutrition
ATS/ACCP Statement: Cardiopulmonary Exercise Testing (Corrected Version) (original accepted by Society 3/10/01). Am J Respir Crit Care Med 2003;167:211-277.
(The joint guidelines address the importance of calibrating equipment and the use of the gas exchange devices as part of exercise tolerance testing.)
Statement: Guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002:166:111-117. Online at:
American Thoracic Society/American College of Chest Physicians (ATS/ACCP). Medically Unlikely Edit Letter. July 30, 2009. (See CCI-Rosen. See Parrish.)
Andralojc KM, Mercalli A, Nowak KW, Albarello L, Calcagno R, Luzi L, et al. Ghrelin-producing epsilon cells in the developing and adult human pancreas. Diabetologia 2009;52:486-493.
Aoki Diabetes Research Institute (ADRI). Online at:
(See SEC. See Diabetex.)
Aoki TT. Patents. Online at:
http://www.wipo.int/pctdb/en/wo.jsp?wo=1985002544; and http://www.patentbuddy.com/Inventor/Patents/Aoki/Thomas/5764214; and http://www.freshpatents.com/Thomas-T-Aoki-Sacramento-invdira.php
Aoki TT. Response to Blue Shield. (Submitted April 20, 2009 with public comments via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institute.)
Aoki TT, Assal J-P, Manzano FM, Kozak GP, Cahill GF. Plasma and cerebrospinal fluid amino acid levels in diabetic ketoacidosis before and after corrective therapy. Diabetes 1975 May;24(5):465-467.
Aoki TT, Benbarka MM. Type I diabetes: The ‘sleeping liver’ hypothesis and its clinical implications. Mod Med 1992 Oct;60:73-76.
Aoki TT, Benbarka MM, Oklmura MC, Arcangeli MA, Walter RM, Wilson LD, et al. Long-term intermittent intravenous insulin therapy and type 1 diabetes mellitus. Lancet 1993 Aug 28;342(8870):515-518.
Aoki TT, Grecu EO, Arcangeli MA. Chronic Intermittent Intravenous Insulin Therapy (CIIIT) corrects orthostatic hypotension of diabetes. Am J Med 1995 Dec;99(6):683-684.
Aoki TT, Grecu EO, Arcangeli MA. Chronic Intermittent Intravenous Insulin Therapy (CIIIT) reduces antihypertensive medication requirements in hypertensive type 1 diabetic patients (IDDM). Diabetes 1993. 204A.
Aoki TT. Grecu EO, Arcangeli MA. The effect of Chronic Intermittent Intravenous Insulin Therapy (CIIIT) on the progression of nephropathy inpatients with type 1 diabetes mellitus (IDDM). Clin Res 1993. 41:109A.
Aoki TT, Grecu EO, Arcangeli MA, Benbarka MM, Prescott P,Ahn JH. Chronic Intermittent Intravenous Insulin Therapy (CIIIT): A new frontier in diabetes therapy. Diabetes Technology and Therapeutics Review 2001 Spring;3(1):111-123.
Aoki TT, Grecu EO, Arcangeli MA, Meisenheimer R. Effect of intensive insulin therapy on abnormal circadian blood pressure pattern inpatients with type 1 diabetes mellitus. Online J Curr Clin Trials 1995b Dec 15;Doc No 19.
Aoki TT, Grecu EO, Gollapudi GM, Barber AR Arcangeli MA, Benbarka MM, et al. Effect of intensive insulin therapy on progression of overt nephropathy inpatients with type 1 diabetes mellitus. Endocr Pract 1999 Jul/Aug;5(4):174-178.
Aoki TT, Grecu EO, Prendergast JJ, Arcangeli MA, Meisenheimer R. Effect of chronic intermittent intravenous insulin therapy on antihypertensive medication requirements in IDDM subjects with hypertension and nephropathy. Diabetes Care 1995 Sept;18(9):1260-1265.
Aoki TT, Muller WA, Brennan MF, Cahill GF JR. Blood cell and plasma amino acid levels across forearm muscle during a protein meal. Diabetes 1973 Oct;22(10):768-775.
Aoki TT, Vlachokosta FV, Foss MC, Meistas MT. Evidence for restoration of hepatic glucose processing in type 1 diabetes mellitus. J Clin Invest 1983 Apr;71(4):837-839.
Aoki TT, White RD. Initiating insulin inpatients with type 2 diabetes. J Fam Pract 2007 Aug;56(Suppl 8):S12-20.
Aron D, Pogach L. Transparency Standards for Diabetes Performance Measures. JAMA 2009 January 14;301(2): 210- 212.
Ashcroft FM. K ATP channels and insulin secretion: a key role in health and disease. Biochemical Society. Transactions 2006. 34;(Part 2):243-246.
Ashcroft FM, Gribble FM. ATP-sensitive K+ channels and insulin secretion: their role in health and disease. Diabetologia 1999. 42:903-919.
Assal JP, Aoki TT, Manzano FM, Kozak GP. Metabolic effects of sodium bicarbonate in management of diabetic ketoacidosis. Diabetes 1974 May;23(5):405-411.
Axelrod L, Shulman GI, Blackshear PJ, Bornstein W, Roussell AM, Aoki TT. Plasma level of 13.14-dihydro-15-keto-PGE2 in patients with diabetic ketoacidosis and in normal fasting subjects. Diabetes 1986 Sep;35(9):1004-1010.
Balanced Budget Act of 1997, H.R. 2015. Provides expanded coverage of glucose monitors and test strips for all diabetics. Implementation July 1, 1998. Online at: http://thomas.loc.gov/cgi-bin/query/z?c105:H.R.2015.ENR
Balkin M, Mascioli C, Smith V, Alnachawati H, Mehrishi S, Saydain G, et al. Research Article. Achieving durable glucose control in the intensive care unit without hypoglycaemia: a new practical IV insulin protocol. Diabetes Metab Res Rev 2007. 23:49-55.
Bantle JP, Wylie-Rosett J, Albright AL, Apovian CM, Clark NG, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care 2008 Jan;31(Suppl 1):S61-78.
Baron AD, Brechtel G, Wallace P, Edelman SV. Fasting decreases rates of noninsulin-mediated glucose uptake in man. J Clin Endocrinol Metab 1988 Sep;67(3):532-540.
Baron AD, Brechtel G, Wallace P, Edelman S. Rates and tissue sites of non-insulin and insulin-mediated glucose uptake in humans. Am J Physiol 1988 Dec;255(6Pt1):E769-774.
Baron AD, Wallace P, Brechtel G. In vivo regulation of non-insulin mediated tend insulin-mediated glucose uptake by cortisol. Diabetes 1987 Nov;36(11):1230-1237.
Bartlett RG. Factors affecting the respiratory quotient. Thesis – University of Maryland. Transcript. College Park, Maryland. 1952.
Basu A, Basu R, Shah P, Vella A, Johnson CM, Nair KS, et al. Effects of type 2 diabetes on the ability of insulin and glucose to regulate splanchnic and muscle glucose metabolism: evidence for a defect in hepatic glucokinase activity. Diabetes 2000 Feb;49(2):272-283.
Benade AJ, Jansen CR, Rogers GG, Wyndham CA, Strydam NB. The significance of an increased RQ after sucrose ingestion during prolonged aerobic exercise. Pfagers Arch 1973 Aug 27;342(3):199-206.
Benbarka MM, Presott PT, Aoki TT. Practical guidelines on the use of insulin lispro in elderly diabetic patients. Drugs Aging 1998 Feb;12(2):103-113.
Bergman RN, Ader M. Free fatty acids and pathogenesis of type 2 diabetes mellitus. Trends Endocrinol Metab 2000 Nov;11(9):351-356.
Bergman N, Vellar ID. Potential life-threatening variations of drug concentrations in intravenous infusion systems: Potassium chloride, insulin, and heparin. Med J Aust 1982 Sep 18;2(6):270-272.
Björklund AO, Adamson UK, Lins PS, Westgren LM. Diminished insulin clearance during late pregnancy inpatients with type1 diabetes mellitus. Clin Science 1998;95:317-323.
Blue Cross Blue Shield of Arkansas. Policy Number 2005001. Chronic Intermittent Intravenous Insulin Therapy (CIIIT). Initiated: January 2005. Last Reviewed: May 2007. Online at http://www.arkansasbluecross.com/members/report.aspx?policyNumber=200501.
Blue Cross Blue Shield of California. Technology Assessment 2001.
Blue Cross Blue Shield of Florida Policy number: 01-99000-04. Chronic Intermittent Intravenous Insulin Therapy (CIIIT) [Pulsatile Intravenous Insulin Therapy (PIVIT), Hepatic Activation, Metabolic Activation]. Effective November 15, 2002. Online at: http://mcgs.bcbsfl.com/?doc=Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Blue Cross Blue Shield of Idaho policy MP 2.01.43. Chronic Intermittent Intravenous Insulin Therapy (CIIIT). Considered investigational. Online at: http://www.bcidaho.com/providers/medical_policies/med/mp_20143.asp
Blue Cross Blue Shield of Massachusetts policy #322. Insulin Delivery Devices and Excluded Services. Do not cover Chronic Intermittent Intravenous Insulin Therapy (CIIIT) or Pulsatile IV Insulin Therapy (PIVIT) due to lack of efficacy. Online at: http://www.bluecrossma.com/common/en_US/medical_policies/332 Insulin Delivery Devices prn.pdf
Blue Cross Blue Shield of Mississippi policy # 2.01.43. Chronic Intermittent Insulin Therapy (CIIT). Non covered as investigational. Online at: https://www.bcbsms.com/index.php?q=member-medical-policy-search.html&action=viewPolicy&path=/policy/emed/Chronic Intermittent Intravenous Insulin Therapy (CIIIT).html
Blue Cross Blue Shield of North Carolina policy #MED1243. Insulin Therapy, Chronic Intermittent Intravenous. Non covered as investigational. Online at: http://www.bcbsnc.com/assets/services/public/pdfs/medicalpolicy/insulin_therapy_chronic_intermittent_intravenous.pdf
Blue Cross and Blue Shield of Washington (Regence Blue Shield Newsletter). Online at: http://www.wa.regence.com/provider/library/newsletters/index.html
Blue Shield’s review of Hepatic Activation. (Submitted April 20, 2009 with public comments via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institite).
Blundell JE, Coding J, King NA. Differences in postprandial responses to fat and carbohydrate loads in habitual high and low fat consumers (phenotypes). Br J Nutr 2002 Aug;88(2):125-132.
Bohannon NJ. Insulin delivery using pen devices. Simple-to-use tools may help young and old alike. Postgrad Med 1999 Oct 15;106(5):57-8, 61-4, 68.
Braithwaite S. Detection and management of diabetes mellitus during glucocorticoid therapy of nocrine disease. In: Meikle AW, ed. Endocrine Replacement Therapy in Clinical practice. Totowa, NJ: Humana Press, Inc, 2003. 251-272.
Braithwaite S, Buie M, Thompson C, Baldwin D, Oertel M, Robertson BA, et al. Hospital hypoglycemia: not only treatment but also prevention. Endocr Pract 2004 Mar-Apr;10 Suppl (2):89-99.
Brandenburg D. History and diagnostic significance of C-peptide. Exp Diabetes Res 2008;576862-576869.
Branson RD. The measurement of energy expenditure: instrumentation, practical considerations, and clinical application. Resp Care 1990. 35:640-656.
Bratusch-Marrain PR, Komjati M, Waldhäusl WK. Efficacy of pulsatile versus continuous insulin administration on hepatic glucose production and glucose utilization in type 1 diabetic humans. Diabetes 1986 Aug;35(8):922-926.
Bratusch-Marrain PR, Komjati M, Waldhäusl WK. Pulsatile insulin delivery: physiology and clinical implications. Diabet Med 1987 May-Jun;4(3):197-200.
Breen PH, Isserles SA, Taitelman UZ. Non-steady state monitoring by respiratory gas exchange. J of Clinical Monitoring and Computing 2000. 16:351-360.
Brogden RN, Heel RC. Human insulin. A review of its biological activity, Pharmacokinetics and therapeutic use. Drugs 1987 Sep;34(3):350-371.
Brown JG (Inspector General) Office of the Inspector General (OIG). Blood glucose test strips: Marketing to Medicare beneficiaries. Department of Health and Human Services. 2000 Jun; OEI-03-98-00231. Online at:
Bruni B, Ricci C, Giolitti A, Osenda M. D’Alberto M. Turco GL. Nuclear Medicine: Insulin antibody production studied quantitatively with a modified radioimmunoassay technique and with radioimmuno-electrophoresis inpatients treated with monocomponent (MC) insulin. J. Nucl. Boil. Med 1973. 17(3):123.
Burge MR, Schade DS. Current Therapies for Diabetes: Insulins. Endocrinol Metab Clin North Am 1997 Sep;26(3):575-598.
Cahill GF Jr, Aoki TT. How metabolism affects clinical problems. Med Times 1970 Oct;98(10):106-122.
Cahill GF Jr, Aoki TT, Ruderman NB. Ketosis. Trans Am Clin Climatol Assoc 1973;84:184-202.
Cahill GF Jr, Rossini AA, Aaoki TT. Metabolic effects of insulin in normal and diabetic man (short review). Endocrinol Exp 1974 Jun;8(2):89-96.
California Court of Appeals upholding the Superior Court decision. (Submitted April 20, 2009 with public comments via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institute.) (Hardcopy available.)
California Healthcare Foundation/American Geriatrics Society Panel on improving Care for Elders with Diabetes: Guidelines for Improving the Care of the Older Person with Diabetes Mellitus. JAGS 2003;51:S265-S280.
California Physicians’ Service Blue Shield v. Aoki Diabetes Research Institute. Super. Ct. No. CGC-03-419872). Filed Jun 17, 2008. Online at: http://www.google.com/search?q=California+Physicians'+Service+v+Aoki+Diabetes+Research+Institute
California Public Employees’ Retirement System (CALPERS): Board of Administration. In the matter of the consolidated appeals of denial of coverage for hepatic activation treatment of: Names withheld (5). Case No.: 3490-5, 3490-3, 3490-2, 3490-1, 3490-4 and 3490-6. (Hardcopy available.)
CALPERS Court Ruling 2002. Online at:
F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\CalPers Decision 4 30 02.pdf
CALPERS Judgement. Online at:
F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\judgment.pdf
CALPERS Legal Issue 6. Online at:
F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\Order Legal Issue 6.pdf
CALPERS Order Re Legal Issues. Online at:
F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\Order Re Legal Issues.pdf
CALPERS Proposed Decision 1.17.02. Online at:
F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\CalPers Proposed Decision 1 17 02.pdf
Canadian Diabetes Association (CDA).
(The CDA does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
(The CDA has a single comprehensive guideline for diabetes.)
Canadian Diabetes Association 2008 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. 2008 September;32 Suppl (1):S1-S201. http://www.diabetes.ca and http://www.diabetes.ca/for-professionals/resources/2008-cpg/
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee.
The most pertinent chapter(s) include:
Diabetes in the Elderly. G Meneilly, D Tessier (initial draft);
Insulin Therapy in Type 1 Diabetes.A Cheng, A Hanna, T Kader, C Richardson;
Pharmacologic Management of Type 2 Diabetes.W Harper, A Hanna, V Woo, K Dawson, JF Yale, L MacCallum, M Clement, S Simpson,M Hopkins (initial draft);
In-hospital management of Diabetes.A Edwards, A Cheng, M Clement, a Hanna, R Houlden, J James (initial draft)
The CDA guideline section on intravenous insulin is delineated in the "In-hospital” chapter.
"Role of Intravenous Insulin Infusion. Intravenous (IV) insulin infusion therapy should be considered during critical illness, or other illness requiring prompt glycemic control, or prolonged fasting (NPO status) (7). IV insulin infusion therapy should be administered only where frequent blood glucose (BG) monitoring and close nursing supervision are possible. Staff education is a critical component of the implementation of an IV insulin infusion protocol. IV insulin protocols should take into account the current and previous BG levels (and, therefore, the rate of change), and the patient’s usual insulin dose.”
Carmel PW, Araki S, Ferin M. Pituitary stalk portal blood collection in rhesus monkeys: evidence for pulsatile release of gonadotropin-rleasing hormone (GnRH). Endocrinol 1976 Jul;99(1):243-248.
Caumo A, Luzi L. First-phase insulin secretion: does it exist in real life? Considerations on shape and function. Am J Physiol Endocrinol Metab 2004 Sep;287(3):E371-E385.
Cavalcanti AB, Silva E, Pereira AJ, Caldeira-Filho M, Almeida FP, Westphal GA, et al. A randomized controlled trial comparing a computer-assisted insulin infusion protocol with a strict and conventional protocol for glucose control in critically ill patients. J of Critical Care. 2009. Article in Press.
Cefalu WT. Evolving strategies for insulin delivery and therapy. Drugs 2004. 64(11):1149-1161.
Centers for Medicare and Medicaid Services (CMS) Program Memorandum Intermediaries/Carriers. Glucose monitoring. Transmittal AB-00-108; Change Request 1362, December 1, 2000. Online at:
Chaiken RL. EXUBERA® (insulin human [rDNA origin] Inhalation Powder) Labeling Update letter. April 9, 2008.
Chan E, Montgomery PA. Administration of insulin by continuous ambulatory peritoneal dialysis. Pharmacotherapy 1993 Sep-Oct;13(5):455-460.
Chance, RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabetes Care 1993. 16(Suppl 3):133-142.
Cheatham B. GLUT4 and Company: SNAREing roles in insulin-regulated glucose update. TEM 2000;11(9):356.
Chemical and Engineering News. Lilly drops inhaled insulin. Move adds to growing list of failures for technology. Pharmaceuticals. 2008 March 17;86(11):9. Online at: http://pubs.acs.org/cen/news/86/i11/8611notw2.html.
Cherrington AD, Sindelar D, Edgerton D, Steiner K, McGuinnes OP. Physiological consequences of phasic insulin release in the normal animal. Diabetes 2002 Feb;51(Suppl 1):S103-S108.
Cheung AT, Ramanujam S, Greer DA, Kumagai LF, Aoki TT. Microvascular abnormalities in the bulbar conjunctiva of patients with type 2 diabetes mellitus. Endocrin Pract 2001 Sep-Oct;7(5)358-363.
Chiarelli F, Verrotti A, Catino M, Sabatino G, Pinelli L. Hypoglycaemia in children with type 1 diabetes mellitus. Acta Paediatr 1999. Jan;427(Suppl):31-34.
CIGNA A41337: Chronic Intermittent Intravenous Insulin Therapy (CIIIT). Article clarifying noncoverage of MAT. Applies to ID, NC, and TN. Online at: http://www.cms.gov/MVD/m_a.asp?id=41337&ver=4&cid=05535
Clark C, Newgard CB. Chapter 5 Hepatic Regulation of Fuel Metabolism. [Saltiel AR, Pessin JE. Editors.] Mechanisms of insulin action. Medical Intelligence Unit. Springer Science+Business Media, New York, New York U.S.A. 2007:90-103. Online at: http://books.google.com/books?id=HUi95xaBBDYC&pg=PA52&lpg=PA52&dq=Mechanisms+of+Insulin+Action&source=bl&ots=zzlqAD5T5B&sig=FzjJ2MxPxpb48D852l1nZN0qYDg&hl=en&ei=4l6mSqbpMcOmlAeGnYGQBA&sa=X&oi=book_result&ct=result&resnum=3#v=onepage&q=Chapter by Clark&f=false
ClinicalTrials.gov. (Personal communication with Dr. Zarin. March 2009.) Online at: http://clinicaltrials.gov/ct2/results?term=pulsatile+insulin+ for: NCT00228891; NCT00228904; NCT00287651; NCT00539435; NCT00361907; NCT00228878; NCT00539409; NCT00228865; and NCT00594152
Cochrane Collaboration External Technology Assessments
i.Farrar D, Tuffnell DJ, West J. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes. July 18, 2007.
ii.Goudswaard AN, Furlong NJ, Valk GD, Stolk RP, Rutten GEHM. Insulin monotherapy versus combinations of insulin with oral hypoglycaemic agents inpatients with type 2 diabetes mellitus. October 18, 2004.
iii.Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J, Pieber TR, Siebenhofer A. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. April 18, 2007.
iv.Onady GM, Stolfi A. Insulin and oral agents for managing cystic fibrosis-related diabetes. July 20, 2005. Update: November 3, 2008.
v.Richter B, Neises G. Human insulin versus animal insulin in people with diabetes mellitus. July 22, 2002. Update: July 31, 2004.
vi. Siebenhofer A, Plank J, Berghold A. Jeitler K, Horvath K, Narath M. Gfrerer R, Pieber TR. Short acting insulin analogues versus regular human insulin inpatients with diabetes mellitus. April 19, 2004. Update: September 21, 2005.
vii.Vardi M. Jacobson E, Nini A, Bitterman H. Intermediate acting versus long acting insulin for type 1 diabetes mellitus. July 16, 2008.
viii.Wagh N. Inhaled insulin in diabetes mellitus. August 28, 2002. Withdrawn November 12, 2008.
(See AHRQ. See NICE.)
Code of Federal Regulations (CFR) Title: 21, Volume 8, Part 812. Investigationsl Device Exemptions. Revised as of April 1, 2008. Online at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=812.3
Code of Federal Regulations (CFR) Title: 21, Volume 1, Part 50. Protection of Human Subjects. Revised as of April 1, 2008. Online at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=50.50
Code of Federal Regulations (CFR) Title: 42, Parts 400, 405, and 426. Medicare Program: Review of national coverage determinations and local coverage determinations. Federal Register 2002 Aug 22;67(163):54534-54563. Online at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/FR08222002.pdf
Coghlan M, Leighton B. Glucokinase activators in diabetes management. Expert Opin. Investig. Drugs 2008;17(2):145-167.
Compher C, Frankenfield D. Roth-Yousey L. Review: Best practice methods to apply to measurement of resting metabolic rate in adults: A systematic review. Journal of the American Dietetic Association 2006 June;106(6):881-903.
Compilation of Social Security Laws, Part E-Miscellaneous Provisions, Definition of Services, Institutions, etc., Section 1861(s)(3). Online at: http://www.ssa.gov/OP_Home/SSact/title18/1861.htm
Conover CA, Rozovski SJ, Belur ER, Aoki TT, Ruderman NB. Ornithine decarboxylase activity in insulin-deficient states. Biochem J 1980 Nov 15;192(2):725-732.
Cooper K. Compliance Oversight Coordinator, Office of Human Research Protections. Eastern Virginia Medical School. Human Research Subject Protections Under Multiple Project Assurance M-1532 and Federal-wide Assurance (FWA) 3956. Jun 15, 2006. Online at:
Correct Coding Initiative letter. Medically Unlikely Edit. July 30, 2009. Rosen/Parish. (Hardcopy available.) (See ACCP/ATS.)
Courtney CH, Atkinson AB, Ennis CN, Sheridan B, Bell PM. Comparison of the priming effects of pulsatile and continous insulin delivery on insulin action in man. Metabolism 2003;52(8):1050-1055.
Cutfield W. Editorial: Short and sweet: the perinatal origins of type 2 diabetes mellitus. Pediatric Diabetes 2004 September 27;5(3):113-116.
Dailey GE, Boden GH, Creech RH, Johnson DG, Gleason RE, Kennedy FP, et al. Effects of Pulsatile Intravenous Insulin Therapy (PIVIT) on the progression of diabetic nephropathy. Metabolism 2000 November;49(11):1491-1495.
DeFronzo RA. Lilly Lecture 1987. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM. Diabetes 1988 Jun;37(6):667-687.
Del Prato S, Marchetti P, Bonadonna RC. Phasic insulin release and metabolic regulation in type 2 diabetes. Diabetes 2000 Feb;51(Suppl 1):S109-S116.
DeMeyts P, Shymko RM. Timing-dependent modulation of insulin mitogenic versus metabolic signaling. Novartis Foundation symposium 2000. 27:46-70.
Department of Health and Human Services Departmental Appeals Board (HHS-DAB). California Appeal of the National Heritage Insurance Company Policy for Outpatient Intravenous Insulin Therapy.
Department of Health and Human Services, U.S. Food and Drug Administration. Regulatory Hearing on the proposal to disqualify Eugen O. Grecu, M.D., Ph.D. from receiving investigational new drugs: Summary decision of the Presiding Officer. Online at:
Department of the Army. Pulsatile Intravenous Insulin Therapy (PIVIT). (Personal communication with Dr. Robert Vigersky, Walter Reed, March 2009.)
Department of the Navy. Pulsatile Intravenous Insulin Therapy (PIVIT). (Personal communications with Dr. Patrick Clyde, National Naval Medical Center, Bethesda, Maryland, March 2009.)
DePergola G, Pannacciulli N, Minenna A, Martina R, Cannito F, Giorgino R. Fuel metabolism in adult individuals with a wide range of body mass index: Effect of a family history of type 2 diabetes. Diab Nutr Metab 2003 Feb;16(1):41-47.
DeSantis A, Schmeltz L, Schmidt K, O’Shea-Mahler E, Rhee C, Wells A. et al. Inpatient management of hyperglycemia: the Northwestern experience. Endocrine Practice 2006. Sep-Oct;12(5):491-505.
Devaraj S, Cheung AT, Jialal I, Griffen SC, Nguyen D, Glasser N, et al. Evidence of increased inflammation and microcirculatory abnormalities inpatients with type 1 diabetes and their role in microvascular complications. Diabetes 2007 Nov;56(11):2790-2796.
Dezaki K, Sone H, Koizumi M, Nakata M, Kakei M, Nagai H, et al. Blockade of pancreatic islet-derived ghrelin enhances insulin secretion to prevent high-fat diet-induced glucose intolerance. Diabetes 2006 Dec;55(12):3486-3493.
Diabetes Control and Complications Trial (DCCT) Research Group. Implementation treatment protocols in the diabetes control and complications trial. Diabetes Care 1995. 18:361-376.
Diabetes Control and Complications Trial (DCCT) Research Group. Lifetime benefits and costs of intensive therapy as practiced in the diabetes control and complications trial. JAMA 1996. 276(17):1409-1415.
Diabetes Control and Complications Trial (DCCT) Research Group, Resource utilization and costs of care in the diabetes control and complications trial. Diabetes Care 1995. 18:1468-1478.
Diabetes Control and Complications Trial (DCCT) Research Group, The absence of a glycemic threshold for the development of long-term complications: the perspective of the diabetes control and complications trial. Diabetes 1996. 45:1289-1298.
Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. NEJM 1993. 329(14):977-986.
Diabetes Network of Researchers, Physicians and Healthcare Professionals. (See VitalCare.) (See Strategic Partners.) Online at: http://www.diabetes.net/
Diabetex International Corporation Securities Exchange Commission (SEC). (See SEC. See ADRI.) Online at: http://www.secinfo.com/d11Eeb.4f89d.b.htm
Diamond E. Developing a Cardiopulmonary Exercise Testing laboratory. American College of Chest Physicians (ACCP). Topics in Practice Management. Chest 2007 December 6;132:2000-2007. Online at: www.chestjournal.org
Dickerson R. Swiggart C, Morgan L, Maish G, Croce M, Minard G, et al. Safety and efficacy of a graduated intravenous insulin infusion protocol in critically ill trauma patients receiving specialized nutritional support. Nutrition 2008 June;24:536-545.
Dierschke DJ, Bhattacharya AN, Atkinson LE, Knobil E. Chichoral oscillations of plasma LH levels in the ovariectomized rhesus monkey. Endocrinology 1970 Nov;87(5):850-853.
Docherty K. Growth and development of the islet of Langerhans: implications for the treatment of diabetes mellitus. Curr Opin Pharmacol. 2001 Dec;1(6):641-650.
Donovan RM, Goldstein E, Kim Y, Lippert W, Kailath E, Aoki TT, et al. A computer-assisted image-analysis system for analyzing polymorphonuclear leukocyte chemotaxis inpatients with diabetes mellitus. J Infec Dis 1987 Apr;155(4):737-741.
Dortch MJ, Mowery NT, Ozdas A, Dossett L, Cao H, Collier B, et al. Original Communications. A computerized insulin infusion titration protocol improves glucose control with less hypoglycemia compared to a manual titration protocol in a trauma intensive care unit. JPEN. J Parenter Enteral Nutr 2008 Jan-Feb;32(1):18-27.
Duckworth W, Abraira C, Moritz T, Reda D, Emanuel N, Reaven PD, et al. Glucose control and vascular complications in veterans with type 2 diabetes. NEJM 2009 January 8;360(2):129-139.
(The Endocrine Society does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
The Endocrine society has a single guideline regarding diabetes.
Primary Prevention of Cardiovascular Disease and Type 2 Diabetes inpatients at Metabolic risk: An Endocrine Society Clinical Practice Guideline-2007. JL Rosenzweig, E Ferrannini, SM Grundy, SM Haffner, RJ Heine, ES Horton, R Kawamori.
Engdahl JH, Veidhuis JD, Farrell PA. Altered pulsatile insulin secretion associated with endurance training. J Appl Physiol 1995 Dec;79(6):1977-1985.
Fallon Community Health Plan. Insulin pumps and insulin pump supplies. Number: 200401-0005. Exclusion from coverage since it is considered experimental and investigational or unproven. Chronic Intermittent Intravenous Insulin Therapy (CIIIT) also referred to as Metabolic Activation Therapy (MAT), or Pulsatile Intravenous Insulin Therapy (PIVIT). Online at: http://www.fchp.org/NR/rdonlyres/262068FD-5BA5-4E9E-999E-6A470B8DCB6E/0/insulinpumps.pdf
Federal Trade Commission: Protecting America’s Consumers: United States of America Federal Trade Commission Washington, D.C. 1996. Online at: http://www.ftc.gov/bc/adops/ama.shtm
Ferrannini E. The theoretical bases of indirect calorimetry: A review. Metabolism 1988 March;37(3):287-301.
Feurer I, Mullen JL. Bedside measurement of resting energy expenditure and respiratory quotient via indirect calorimetry. Nutr Clin Pract 1986. 1:43-49.
First Coast Service Options (FCSO). Article for NCSVCS: The List of Medicare on covered Services-99199 Pulsatile Intraveneous Insulin Therapy (PIVIT) – Article Clarification (A48110) July 30, 2008. http://www.cms.gov/MCD/viewarticle.asp?article_id=48110&article_version=2&show=all
First Coast Service Options (FCSO) LCD for "List of Medicare Noncovered Services” (L5780) lists Pulsatile Intravenous Insulin Therapy, aka Metabolic Activation Therapy (99199) as a service that is never covered by the Medicare program. http://www.cms.gov/MCD/m_d.asp?id=5780&ver=54&cid=00590
Food and Drug Administration (FDA). Advisory Committee Meeting Transcript for Glucose Monitors. 2001. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=260
Food and Drug Administration (FDA). Alerts for Glucose Meters. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162016.htm and http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049051.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm and http://www.accessible-devices.com/glucose.html and http://www.consumeraffairs.com/news04/2005/fda_glucose_meters.html
Food and Drug Administration (FDA). Apidra Label Use. Online at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021629s001,002lbl.pdf
Food and Drug Administration (FDA). Center for Devices and Radiological Health. Review Criteria Assessment of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. Draft Document. Online at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094134.htm
Food and Drug Administration (FDA). Center for Devices and Radiological Health. Review of HemoCue Device. BK 060048 letter. Online at: http://www.consumeraffairs.com/news04/2005/fda_glucose_meters.html
Food and Drug Administration (FDA). Center for Devices and Radiological Health. Review of i-Stat Device. Online at: http://google2.fda.gov/search?q=i-STAT&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*
Food and Drug Administration (FDA). Center for Devices and Radiological Health. Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices, Part 868, Anesthesiology Devices. Online at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=868
Food and Drug Administration (FDA). Dear Doctor Letter. Exubra. 2008. DOC, Drugs.com. Online at: http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm126610.pdf
Food and Drug Administration (FDA). Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER): Vaccines, Blood and Biologics. Online at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/InvestigationalNewDrugINDorDeviceExemptionIDEProcess/default.htm
Food and Drug Administration (FDA). Medical Devices: Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps. Online at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081337.htm
Food and Drug Administration (FDA). Meter Test Reagent Warnings. Online at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm
Food and Drug Administration (FDA). Medical Devices: Products and medical procedures. Online at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm123672.htm
Food and Drug Administration (FDA). Meter Review Criteria. Online at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=260
Food and Drug Administration (FDA). Regular human insulin (Novolin R in 2005) Label Use. Online at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf
Food and Drug Administration (FDA). Regulatory Information: "Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices – Information Sheet. Online at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm
Food and Drug Administration (FDA). Request COSMED SRl, Italy. COSMAD, fitmate Review of portable metabolic cart and summary including indications for use. 2007. Online at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071533.pdf
Foss MC, Aoki TT. Effects of glucose loads of 50 and 100 g on carbohydrate and lipid oxidation in normal human subjects. Braz j Med Biol Res 1988;21(4):773-779.
Foss MC, Aoki TT. Restoration of fuel homeostasis in IDDM patients during pregnancy by an open-loop insulin infusion system. Diabetes Care 1993 January;16(1):103-109.
Foss MC, Cunningham LN, Aoki TT. Hormone-fuel metabolism during exercise of insulin-dependent diabetic patients treated with an artificial B-cell unit. Acta Diabetol Lat 1989 Jul-Sep;26(3):185-194.
Foss MC, Viachokosta FV, Cunningham LN, Aoki TT. Restoration of glucose homeostasis in insulin-dependent diabetic subjects: An inducible process. Diabetes 1982. 31(1):46-52.
Foss MC, Flachokosta FV, Aoki TT. Carbohydrate, lipid and amino acid metabolism of insulin-dependent diabetic patients regulated by an artificial beta-cell unit. Diabetes Res 1989 May;11(1):1-8.
Foss MC, Von-Oeyen P, Vlachokosta FV, Aoki TT. Fuel oxidation by insulin-dependent diabetics during late pregnancy in response to an oral glucose load. Braz J Med Biol Res 1992;25(2):135-144.
Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making 1991;11(2):88-94.
Furnary AP, Zerr KJ, Grunkemeier GI, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sterna wound infestion in diabetic patients after cardiac surgical procedures [with discussion]. Ann Thorac Surg 1999. 67:352-362.
Furnary AP, Gao G, Grunhemeir GL, Wa Y, Zeor KJ, Borkin So, et al. Continuous insulin infusion mortality inpatients with diabetews underging coronary artery bypass grafting. J Thorac Cardiovasc Surg 2003 May;125(5):1007-1021.
Fujii TK, Phillips BJ. Quick review: The metabolic cart. Internet J Intern Med. 2003. 3(2). Online at:http://www.ispub.com/journal/the_internet_journal_of_internal_medicine/volume_3_number_2_25/article_printable/quick_review_the_metabolic_cart.html
Fujita Y, Herron AL, Seltzer HS. Confirmation of impaired early insulin response to glycaemic stimulus in non-obese mild diabetics. Diabetes 1975 January;24:17-27.
Gaines AR, Pierce LR, Bernhardt PA. Fatal Iatrogenic Hypoglycemia: Falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Food and Drug Administration 2005. Online at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm
Galvin P, Ward G, Walters J, Pestell R, Koschmann M, Vaag A, et al. A simple method for quantitation of insulin sensitivity and insulin release from an intravenous glucose tolerance test. Diabetic Medicine 1992. 9:921-928.
Gandhi G, Murad M, Flynn D, Erwin P, Cavalcante A, Bay NH, et al. Effect of perioperative insulin infusion on surgical morbidity and mortality: Systematic review and meta-analysis of randomized trials. Mayo Clin Proc 2008 April;83(4):418-430.
Gilbert Pump Patents. Strategic Partners: Bionica. VCTE Strategic partners. November 20, 2007. Online at: http://docs.google.com/gview?a=v&q=cache:6PpfL80xit4J:www.vitalcaretechnology.com/Pdf/Strategic%20Partners%20feb2908.pdf+Gilbert+Pump+Patents&hl=en&gl=us
Gill G, Williams G. Long-term intermittent intravenous therapy and type 1 diabetes. Lancet 1993 Oct 23;342(8878):1056-1057.
Gill G, Williams Gareth, Lamb WH (Editorial). Long-term intermittent intravenous therapy and type 1 diabetes mellitus. Lancet 1993 Oct 23;342:1056-1057.
Goodman MN, Ruderman NB, Aoki TT. Glucose and amino acid metabolism in perfused skeletal muscle. Effect of dichloroacetate. Diabetes 1978 Nov;27(11):1065-1074.
Goodner CJ, Hom FG, Koerker DJ. Hepatic glucose production oscillates in synchrony with the islet secretory cycle in fasting rhesus monkeys. Science 1982 Mar 5;215(4537):1257-1260.
Goodner CJ, Walike BC, Koerker DJ, Ensinck JW, Brown AC, Chideckel EW, et al. Insulin glucagon, and glucose exhibit synchronous, sustained oscillations in fasting monkeys. Science 1977 Jan 14;195(4274):177-179.
Granato L, Brandes A, Bruni C, Greco AV, Mingrone G. V02, VC02 and RQ in a respiratory chamber: accurae estimation based on a new mathematical model using the Kalman-Bucy method. J Appl Physiol 2004. 96:1045-1054.
Grecu. Food and Drug Administration (FDA) Sanction.
Gredal C, Rosenfalck AM, Dejgaard A, Hilsted J. Impaired first-phase insulin response predicts postprandial blood glucose increment in patients with recently diagnosed type 2 diabetes. Scand J Clin Lab Invesst 2007. 67(3):327-336.
Grimsby J, Sarabu R, Corbett W, Haynes N, Bizzarro F, Coffey J, et al. Allosteric activators of glucokinase: Potential role in diabetes therapy. Science 2003 July 18; 301:370-373.
Grissinger M. Reducing medication errors associated with intravenous insulin infusions. Pharmacy and Therapeutics 2003;28(10):628.
Gromada J, Franklin I, Wolheim CB. Alpha-cells of the endocrine pancreas: 35 years of research but the enigma remains. Endocr Rev. 2007 Feb;28(1):84-116.
Grubert JM, Lautz M, Lacy DB, Moore MC, Farmer B, Penaloza A, et al. Impact of continuous and pulsatile insulin delivery on net hepatic glucose update. Am J Physiol Endocrinol Metab 2005. 289:E232-E240.
Guimarães GV, Carvalho VO, Bocchi EA. Clinical Science: Reproducibility of the self-controlled six-minute walking test in heart failure patients. Clinics 2008. 63(2):201-206.
Gulan M, Perlman K, Albisser MA, Pyper J, Zinman B. Controlled crossover study of subcutaneous and intravenous insulin infusion in type I diabetes. Diabetes Care 1987 July-August;10(4):453-460.
Gunn JM, Taylor CB. Relationships between concentration of hepatic intermediary metabolites and induction of the key glycolytic enzymes in vivo. Biochem J 1973 Nov;136(3):455-465.
Hagedorn H, Jensen B, Krarup N, Wodstrup I. Protamine insulinate. J. Am. Med. Assoc 1936 Jan 18;106:177-180.
Hammond GS, Aoki TT. Measurement of health status in diabetic patients. Diabetes impact measurement scales. Diabetes Care 1992 Apr;15(4):469-477.
Hariharan N, Farrelly D, Hagan D, Hillyer D, Arbenny C, Sabrah T, et al. Expression of human hepatic glucokinase in transgenic mice liver results in decreased glucose levels and reduced body weight. Diabetes 1997 January;46:11-16.
Harrower AD. Treatment of diabetic ketoacidosis by direct addition of insulin to intravenous infusion. A comparison of "high dose” and "low dose” techniques. Br J Clin Pract 1979 Mar;33(3):85-86.
HAYES Alert Technology Assessment Brief. "Chronic Intermittent Intravenous Insulin Therapy for Type 1 DM”. June 2006.
HAYES Medical Technology Directory. "Chronic Intermittent Intravenous Insulin Therapy (CIIIT) for Type 1 Diabetes Mellitus”. July 14, 2006. Updated August 15, 2007 and September 29, 2008. (Personal communication with Pat Williamson on May 21, 2009.)
Heard CR, Henry PA. Glucose tolerance and insulin sensitivity. Clin Sci 1969. 37:37-44.
Heinemann L. Chronic intermittent intravenous insulin therapy: Really a new therapeutic option? Diabetes Technology and Therapeutics 2001. 3(1):125-127.
Heinemann L. Comment regarding: Pulsatile Insulin Therapy. Profil Institute for Metabolic Resarch GmbH. Neuss, Germany. June 15, 2009.
Heinemann L, Sonnenberg GE, Hohmann A, Ritzenhoff A, Berger M, Benn J, et al. Pulsatile insulin infusion and glucose-homeostasis in well-controlled type 1 (insulin-dependent) diabetic patients. J Internal Medicine 1989. 226(5):325-330.
Heller S, Kozlovski P, Kurtzhals P. Insulin’s 85th Anniversary-An enduring medical miracle. Diabetes Res Clin Pract 2007 Nov;78(2):149-158.
Hellman R. A systems approach to reducing errors in insulin therapy in the inpatient setting. Endocr Pract 2004 Mar-Apr;10 Suppl (2):100-8.
Henney JE. FDA Commissioner. Letter: Affirming and adopting the Food and Drug Administration, Summary Decision of the Presiding Officer, dated March 25, 1999. Online at: http://www.fda.gov/downloads/RegulatoryInformation/FOI/Electronic Reading Room/UCM143923.pdf; and http://www.fda.gov/downloads/RegulatoryInformation/FOI/Electronic Reading Room/UCM143923.pdf
Henquin JC, Boitard C, Efendie S, Ferrannini E, Steiner DF, Cerasi E. Editorial. Insulin secretion: Movement at all levels. Diabetes 2002 Feb;51(Suppl 1):S1-S2.
Henry CJK. Basal metabolic rate studies in humans: measurement and development of new equations. Public Health Nutrition 2005. 87(7A):1133-1152. Online at: http://journals.cambridge.org/download.php?file=/PHN/PHN8_7a/S1368980005001394a.pdf&code=fcaf1352a42a9f4d892e95a86818a91c
Hills, CE, Brunskill NJ. Intracellular Signalling by C-peptide. Experimental Diabetes Research 2008;2008:635158-635166.
Hollander-Roderiguez JC, Calvert JF. Hyperkalemia. American Family Physiscian 2006 January 15;73(2):283-290.
Hollingdal M, Juhl CB, Pincus SM, Sturis J, Veldhuis JD, Polonsky KS, et al. Failure of physiological plasma glucose excursions to entrain high-frequency pulsatile insulin secretion in type 2 diabetes. Diabetes 2000. 49:1334-1340.
Holstein A, Plaschke A, Egberts E. Clinical characterization of severe hypoglycaemia—a prospective population-based study. Exp Clin Endocrinol Diabetes 2003 Sept;111:364-369.
[Johns] Hopkins Bayview Medical Center. General Clinical Research Center: Metabolic Cart Procedure. Policy No: 159, April 10, 2003. (See Johns.) Online at: http://jhbgcrc.jhu.edu/PolicyProcedure/Metabolic Cart Procedure 20030410.pdf
Home PD, Alberti KG. The new insulins. Their characteristics and clinical indications. Drugs 1982 Nov;24(5):401-413.
Hou JC, Min L, Pessin JE. Insulin granule biogenesis, trafficking and exocytosis. Chapter Sixteen. Vitamins and Hormones. Elsevier Inc., Amsterdam, The Netherlands. 2009;80:473-506.
Hovorka R. Continuous glucose monitoring and closed-loop systems. Diabet Med 2006 Jan;23(1):1-12.
Hovorka R. The future of continuous glucose monitoring: Closed Loop. Current Diabetes Reviews 2008. 4(3):269-279.
Huang ES, Basu A, O’Grady MJ, Capretta JC. Using clinical information to project federal health care spending. Health Affairs – Web Exclusive 2009 September 1:w978- w-990. Online at: http://content.healthaffairs.org/cgi/content/full/hlthaff.28.5.w978/DC1
Hunter SJ, Atkinson AB, Ennis CN, Sheridan B, Bell PM. Association between insulin secretory pulse frequency and peripheral insulin action in NIDDM and normal subjects. Diabetes 1996 May;45(5):683-686.
Iannuzzi A, Licenziati MR, Acampora C, Salvatore V, Marco DD, Mayer MC, et al. Preclinical changes in the mechanical properties of abdominal aorta in obese children. Metabolism 2004. 53(9):1243-1246.
Igawa S, Sakamaki M, Miyazaki M. Examination of the reliability of the portable calorimeter. Clinical and Experimental Pharmacology and Physiology 2002. 29;S13-S15.
Inside Wall Street Report: for Tuesday April 22nd, 2008. VitalCare Announces FDA approval of infusion device used for iCAT therapy. (See VitalCare) Online at: http://www.insidewallstreetreport.com/quotebox_VDTI_profile_042408.html
Jaffee RS, Aoki TT, Rohatsch PL, Disbrow EA, Fung DL. Predicting cardiac autonomic neuropathy in type 1 (insulin-dependent) diabetes mellitus. Clin Auton Res 1995 Jun;5(3):155-158.
Jarvis L. Lilly drops inhaled insulin: Move adds to growing list of failures for the technology. Chemical and Engineering News. 2008 March 17;86(11):9. Online at: http://pubs.acs.org/cen/news/86/i11/8611notw2.html
Jensen K, Jørgensen S, Johnsen L. A metabolic cart for measurement of oxygen uptake during human exercise using inspiratory flow rate. Eur J Appl Physiol 2002;87:202-206.
Jensen MV, Joseph JW, Ronnebaum SM, Burgess SC, Sherry AD, Newgard CB. Metabolic cycling in control of glucose-stimulated insulin secretion. Am J Physiol Endocrinol Metab 2008 Dec;295(6):E1287-1297.
Johns Hopkins Bayview Medical Center. General Clinical Research Center: Metabolic Cart Procedure. Policy No: 159, April 10, 2003. (See Hopkins) Online at: http://jhbgcrc.jhu.edu/PolicyProcedure/Metabolic Cart Procedure 20030410.pdf
Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Joint commission IDs five high-alert meds. ED Manag 2000 Feb;12(2):21-22.
Juhl CB, Porksen N, Hollingdal M, Sturis J, Pincus S, Veldhuis JD, et al. Repagliride acutely amplifies pulsatile insulin secretion by augmentation of burst mass with no effect on burst frequency. Diabetes Care 2000;23(5):675-681.
Juhl CB, Porksen N, Pincus SM, Hansen ÅP, Veldhuis JD, Schmitz O. Acute and short-ter administration of a sulfonylurea (Gliclazide) increases pulsatile insulin secretion in type 2 diabetes. Diabetes 2001;50:1778-1784.
Juhl CB, Schmitz O, Pincus S, Holst JJ, Veldhuis J, Porksen N. Short-term treatment with GLP-1 increases pulsatile insulin secretion in Type II diabetes with no effect on orderliness. Diabetologia 2000;43:583-588.
Juhl CB, Sturis J, Hollingdal M, Schmitz O. Acute insulin responses to intravenous glucose and GLP-1 are independent of preceding high-frequency insulin pulse-defects induced by glucose entrainment in Healthy Humans. Horm Metab Res. 2005;37:40-44.
Juvenile Diabetes Research Foundation (JDRF)
(The JDRF does not have clinical practice guidelines.)
Kanji S, Singh A, Tierney M, Meggison H, McIntyre L, Herbert PC. Standardization of intravenous insulin therapy improves the efficiency and safety of blood glucose control in critically ill adults. Intensive Care Med 2004 May;30(5):804-810.
Keegan A. Weak sales lead to Exubera’s market withdrawal. ADA DOC News. December 2007. Online at: http://docnews.diabetesjournals.org/content/4/12/5.1.full
Kerner W, Brückel J, Zier H, Arias P, Thun C, Moncayo R, et al. Similar effects of pulsatile and constant intravenous insulin delivery. Diabetes Res Clin Pract 1988 Apr 6;4(4):269-274.
Khafagy E, Morishita M, Onuki Y, Takayama K. Current challenges in non-invasive insulin delivery systems:A comparative review. Adv Drug Delivery Rev 2007 August 16;59:1521-1546.
Kitabchi AE, Umpierrez GE, Murphy MB, et al. (American Diabetes Association). Hyperglycemic crises inpatients with diabetes mellitus. Diabetes Care 2003;26 Suppl (1):S109-S117.
Knapke CM, Owens JP, Mirtallo JM. Management of glucose abnormalities inpatients receiving total parenteral nutrition. Clin Pharm 1989;8:136-144.
Koch B. Selected topics of hypoglycemia care. Canadian Family Physician 2006 April;52:466-471.
Kocoglu H, Goksu S, Pence S, Soykan B, Kocak T, Yilmaz N. Insulin dose versus rate of potassium decrease in the treatment of hyperkalemia with IV insulin during extracorporeal circulation: an observational study. Current Therapeeutic Research 2002;63(9):549-555.
Koerker DJ, Goodner CJ, Hansen BW, Brown AC, Rubenstein AH. Synchronous, sustained oscillation of C-peptide and insulin in the plasma of fasting monkeys. Endocrinology 1978 May;102(5):1649-1652.
Koopmans AJ, Sips HC, Krans HM, Raddar JK. Pulsatile intravenous insulin replacement in streptozotocin-diabetic rats is more efficient than continous delivery: effects on glycaemic control insulin-mediated glucose metabolism and lipolysis. Diabetologia 1996 Apr;39(4):391-400.
Korp W, Levett RE. Experiences with monocomponent insulin treatment. Wien Klin Wochenschr 1973;85(18):326-330.
Kost GJ, Vu HT, Lee JH, Bourgeois P, Kiechie FL, Martin C, et al. Multicenter study of oxygen-insensitive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the united States and Canada. Crit Car Med 1998 Mar;26(3):581-590.
Kumai M, Tamai H, Fujii S, Nakagawa T, Aoki TT. Glucagon secretion in anorexia nervosa. Am J Clin Nutr 1988 Feb;47(2):239-242.
Ladisch MR, Kohlmann KL. Recombinant human insulin. Biotechnol. Prog 1992;8(6):469-478.
Laedtke T, Kjems L, Porksen N, Schmitz O, Velduis J, Kao PC, et al. Overnight inhibition of insulin secretion restores pulsatility and proinsulin/insulin ratio in type 2 diabetes. Am J Physiol Endocrinol Metab 2000;279:E520-E528.
Lang DA, Matthews DR, Peto J, Turner RC. Cyclic oscillations of basal plasma glucose and insulin concentrations in human beings. N Engl J Med 1979 Nov8;301(19):1023-1027.
Lang DA, Matthews DR, Burnett M, Ward GM, Turner RC. Pulsatile, synchronous basal insulin and glucagon secretion in man. Diabetes 1982 Jan;31(1):22-26.
Lang DA, Matthews DR, Burnett M, Turner RC. Brief, irregular oscillations of basal plasma insulin and glucose concentrations in diabetic man. Diabetes 1981;30:435-439.
Lazar HL, Chipkin S, Phillippides G, Bao Y, Apstein C. Glucose-insulin-potassium solutions improve outcomes in diabetics who have coronary artery operations. Ann Thorac Surg 2000;70:145-150.
Larsen T, Jørgensen JO, Jakobsen G, Hansen BL, Christiansen JS. Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH-deficient patients. J Clin Endocrinol Metab 1995;80(8):2410-2418.
Laursen T, Jørgensen JO, Jakobsen G, Hansen BL, Christiansen JS. Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH-deficient patients. J of Clin endocrinology and Metabolism.1995;80(8):2410-2418.
Lavernia F. Treating hyperglycemia and diabetes with insulin therapy: transition from inpatient to outpatient care. J Med 2008 September 17;10(9):216. Online at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=docline&pubmedid-19008977.
Lefebvre PJ, Paolisso G, Scheen AJ, Henquin JC. Review. Pulsatility of insulin and glucagon release physiological significance and pharmacological implications. Diabetologia 1987 July;30(7):443-452.
Letter outlining the sale of VitalCare Technology enterprises (SELLER) to Modern Technology Corp (BUYER). July 4, 2007. Online at: http://www.secinfo.com/d1Z7X7.u7e.d.htm
Levy-Marchal C, Albisser AM, Zinman B. Overnight metabolic control with pulsed intermittent versus continuous subcutaneous insulin infusion. Diabetes Care 1983;6:356-360.
Lew’s Assessment of the statistical design of three studies on hepatic activation. (Submitted April 20, 2009 with public comment via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institute.)
Lien L, Spratt S, Woods Z, Osborne K, Feinglos M. Optimizing hospital use of intravenous insulin therapy: improved management of hyperglycemia and error reduction with a new nomogram. Endocrine Practice 2005 Jul-Aug;11(4):240-253.
Logan-Darrough M. Pulsatile I.V. Insulin Therapy for severely out of control diabetes. J Intravenous Nursing 1995;18(3):124-128.
Luksch A, Polak K, Matulla B, Dallinger S, Kapiotis S, Rainer G, et al. Glucose and insulin exert additive ocular and renal vasodilator effects on healthy humans. Diabetologia 2001;44:95-103.
Maffeis C, Schutz Y, Chini L, Grezzani A, Piccoli R, Tató L. Effects of dinner composition on postprandial macronutrient. Obesity Research 2004 July;12(7):1128-1135.
Malmberg K (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction [DIGAMI] Study Group). Prospective randomized study of intensive insulin treatment on long term survival after acute myocardial infarction inpatients with diabetes mellitus. BMJ 1997 May;314(7093):1512-1515.
Mansell PI, Macdonald IA. Reappraisal of the Weir equation for calculation of metabolic rate. Am J Physiol Regulatory Integrative Comp Physiol 1990 Jun;258(6 Pt 2):1347-1354.
Mari A, Camastra S, Toschi E, Giancaterini A, Gastaldelli A, Mingrone G, et al. A model for glucose control of insulin secretion during 24 h of free living. Diabetes.2001 Feb;50(Supple 1):164-168.
Marliss EB, Ohman JL Jr, Aoki TT, Kozak GP. Altered redox state obscuring ketoacidosis in diabetic patients with lactic acidosis. NEJM 1970 Oct 29;283(18):978-980.
Martens GA, Pipeleers D. Glucose, regulator of survival and phenotype of pancreatic beta cells. Chapter Seventeen. Vitamins and Hormones. Academic Press. Elsevier Inc., Amsterdam, The Netherlands. 2009;80:507-539.
MAT Protocol. (Submitted April 20, 2009 with public comment via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institute.) (Hardcopy available.) (See ADRI.)
Mateo F, Torres NV, Meléndez-Hevia E. Role of hexokinase in controlling the glucose metabolism flux: A study of its flux control coefficient in different tissues. Cellular and Molecular Biology 1989;35(1);33-37.
Matschinsky FM, Magnuson MA, Zelent D, Jetton TL, Doliba N, Yan Y, et al. The network of glucokinase-expressing cells in glucose homeostasis and the potential of glucokinase activators for diabetes therapy. Diabetes 2006 January;55:1-12.
Matthews DR. Physiological implications of pulsatile hormone secretion. Am NY Acad Sci 1991;618:28-37.
Matthews DR, Lang DA, Burnett MA, Turner RC. Control of pulsatile insulin secretion in man. Diabetologia 1983 Apr;24(4):231-237.
Matthews DR, Naylor BA, Jones RG, Ward GM, Turner RC. Pulsatile insulin has greater hypoglycemic effect. Diabetes 1983 Jul;32(7):617-621.
McCarren M. [Special Report] Make the most of your meter. Diabetic Living. Fall 2009:39-47.
McClave SA, Lowen CC, Kleber MJ, McConnell JW, Jung LY, Goldsmith LJ. Clinical use of the respiratory quotient obtained from indirect calorimetry. J Parent Enterol Nutr 2003 Jan/Feb;27(1):21-26.
McClave SA, Snider HL. Use of indirect calorimetry in clinical nutrition. Nutr Clin Pract: Official Publication of the American society for Parenteral and Enteral Nutrition 1992 Oct;7(5):207-221.
McGregor IS, Lee AM. Metabolic changes associated with ingestion of different macronutrients and different meal sizes in rats. Physiol Behav 1995 Feb;57(2):277-286.
Medicare Benefit Policy Manual, Chapter 15, Section 50.2. Determining self-administration of drug or biological. Internet Only Manual 100-02. Online at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf
Medicare Contractor Local Coverage Determinations Process. Online at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c13.pdf
Medicare Decision Memo for Clinical Trial Policy (CAG-00071R). Online at: http://www.cms.gov/mcd/viewdecisionmemo.asp?id=186
Medicare Evidence Development and Coverage Advisory Committee (MedCAC). Glycemic Control. August 2006. Online at: http://www.cms.gov/mcd/viewmcac.asp?where=index&mid=36
Medicare Guidance for the Public, Industry, and CMS Staff National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development: Document Issued on July 12, 2006. Online at: https://www.cms.gov/mcd/ncpc_view_document.asp?id=8
Medicare Local Coverage Determination (LCD) for Diabetes Mellitus Therapy using Hepatic Activation or PIVIT Therapy (L28252). Online at: http://www.cms.gov/mcd/viewlcd_pdf.asp?lcd_id=28252&lcd_version=10&contractor_id=174
Medicare. National Correct Coding Initiatives (NCCI) Edits. Online at: http://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html#TopOfPage
Medicare National Coverage Determination (NCD) for Closed-Loop Blood Glucose Control Device (CBGCD) (40.3). Online at: http://www.cms.gov/mcd/viewncd.asp?ncd_id=40.3&ncd_version=1&basket=ncd:40.3:1:Closed-Loop+Blood+Glucose+Control+Device+(CBGCD) >
Medicare National Coverage Determination (NCD) for Home Blood Glucose Monitors 40.2. Online at: http://www.cms.gov/mcd/viewncd.asp?ncd_id=40.2&ncd_version=2&basket=ncd:40.2:2:Home+Blood+Glucose+Monitors
Medicare National Coverage Determination (NCD) for Insulin Infusion Pump 280.14. Online at: http://www.cms.gov/mcd/viewdecisionmemo.asp?id=40
Medicare Part B systems Extract and Summary System (BESS) Procedure Summary File for Respiratory quotient CPTs=94681; 94690, 94621 in 2000-2007. Data pulled 2008.
Medicare Program Memorandum for Intermediaries/Carriers: AB-00-108. Glucose Monitoring. Change Request 1362. December 1, 2000. Online at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/AB00108.pdf
Medicare Medically Unlikely Edits (MUEs). Online at: http://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/MUE.html
Meguro S, Funae O, Hosokawa K. Atsumi Y. Hypoglycemia detection rate differs among blood glucose monitoring sites. Diabetes Care 2005 March;28(3);708-709.
Meier JJ, Veldhuis JD, Butler PC. Pulsatile insulin secretion dictates systemic insulin delivery by regulating hepatic insulin extraction in humans. Diabetes 2005;(54):1649-1656.
Meier JJ, Veldhuis JD, Butler PC. Pulsatile insulin secretion dictates systemic insulin delivery by regulating hepatic insulin extraction in humans. Diabetes 2005;(54):1649-1656.
Meistas MT, Vlachokosta FV, Gleason RE, Arcangeli M, Aoki TT. Role of muscle in C02 production after oral glucose administration in man. Diabetes 1985 Oct;34(10):960-963.
Meneghini L. Review Article. Demonstrating strategies for initiation of insulin therapy: matching the right insulin to the right patient. Int J Clin Pract 2008 Aug;62(8):1255-1264.
Meneilly GS, Veldhuis JD, Elahi, D. Disruption of the pulsatile and entropic modes of insulin release during an unvarying glucose stimulus in elderly individuals. J Clin Endocrinol Metab 2009;84(6):1938-1943.
Metabolic Industries (MI). Online at: http://www.metabolicactivationtherapy.com/company.htm and http://www.metabolicactivationtherapy.com/news.htm and http://www.metabolicactivationtherapy.com/no-rights-to-mat.htm
Millis RM, Austin RE, Bond V, Faruque M, Goring KL, Hickey BM, et al. Effects of high-carbohydrate and high-fat dietary treatments on measures of heart rate variability and sympathovagal balance. Life Sciences 2009 Jul 17;85(3-4):141-145.
Mirbolooki, MR, Taylor GE, Knutzen VK, Scharp DW, Wilcourt R, Lakey JR. Pulsatile intravenous insulin therapy: The best practice to reverse diabetes complications? 2009. Article in Press. Online at: http://www.sciencedirect.com/science?_ob=MImg&_imagekey=B6WN2-4W99NT7-1-5&_cdi=6950&_user=10843&_orig=search&_coverDate=05/15/2009&_sk=999999999&view=c&wchp=dGLbVlz-zSkWA&md5=b44130a2e5340e4360cb0155e01dd80a&ie=/sdarticle.pdf
Moore L. Novo Nordisk refocuses its activities within inhaled insulin and discontinues the development of AERx. Drugs.com. January 14, 2008. Online at: http://www.drugs.com/news/novo-nordisk-refocuses-activities-within-inhaled -insulin-discontinues-development-aerx-7555.html
Moore MC, Cherrington AD, Wasserman DH. Regulation of hepatic and peripheral glucose disposal. Regulation of hepatic glucose disposal by metabolites and hormones. Best Practice & Research Clinical Endocrinology & Metabolism 2003;17(3):343-364.
Muller WA, Brennan MF, Tan MH, Aoaki TT. Studies of glucagon secretion in pancreatectomized patients. Diabetes1974 Jun;23(6):512-516.
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. Diabetes Care 2008 Dec;32(12):1-11.
Nathan DM, Dunn FL, Bruch J, McKitrick C, Larkin M, Haggan C, et al. Posprandial insulin profiles with implantable pump therapy may explain decreased frequency of severe hypoglycemia, compared with intensive subcutaneous regimens, in insulin-dependent diabetes mellitus patients. Am J of Med 1996;100:412-417.
National Collaborating Center for Chronic Conditions. Type 1 diabetes in adults. National clinical guideline for diagnosis and management in primary and secondary care. London (UK): Royal College of Physicians. 2004. [382 references]:171. Online at: http://www.guideline.gov/summary/summary.aspx?doc_id=6249
National Heritage Insurance Company (NHIC) followed by Palmetto GBA. Noncoverage PIVIT Policy. Circa 2000. (See Appendix 14 NHIC-Palmetto Policy.) Online at: http://coverage.cms.fu.com/mcd_archive/search.asp?clickon=search; and http://www.cms.gov/mcd/viewlcd.asp?lcd_id=28252&lcd_version=10&=all
National Institute of Health/Food and Drug Administration Workshop. Closed-loop insulin infusion systems (Artificial pancreas). 2008. Online at: http://diabetes.niddk.nih.gov/about/dateline/fall08/1.htm; and http://videocast.nih.gov/launch.asp?14598 and http://videocast.nih.gov/launch.asp?14601
National Institute for Health and Clinical Excellence (NICE) External Technology Assessments
i.Simultaneous pancreas-kidney transplants in diabetic patients. January 2008. Updated January 2009.
ii.Pancreas after kidney transplantation in diabetic patients. June 2006. Updated July 2008.
iii.Needle-free insulin injection systems. September 18, 2006.
iv.Pancreas transplantation alone. Marcy 1999. Updated February 26, 2006.
v.Islet cell transplantation for the treatment of type 1 diabetes. August 2004. Updated August 2005.
vi.Guideline Development Group. Type 2 diabetes: The management of diabetes (update) NICE guideline CG66 Diabetes – type 2 (update): December 5, 2008 vs. May 2008.
Diabetes (type 2)-glitazones TA63. August 2003 (but replaced by CG66)
Diabetes (type 2)-ioglitazone TA21. March 2001 (but replaced by TA63)
Diabetes (type 2)-rosiglitazone TA9. August 2000 (but replaced by TA63)
vii.Aberdeen HTA Group Continuous subcutaneous insulin infusion for the treatment of diabetes (review) TA151. July 2008.
Southampton HTA, University of Southampton. The clinical effectiveness and cost effectiveness of insulin pump therapy TA57. April 2003.
viii.Aberdeen HTA Group. Inhaled insulin for the treatment of type 1 and type 2 diabetes TA113. Made obsolete: January 2008
Diabetes (types 1 and 2) - Patient education models. August 2003.
ix.School of Health and Related Research. University of Sheffield. The clinical effectiveness and cost effectiveness of long acting insulin analogues for diabetes TA53. December 2002.
(See AHRQ. See Cochrane.)
Nielsen S, Guo ZK, Albu JB, Klein S, O’Brien PC, Jensen MD. Energy expenditure, sex, and endogenous fuel availability in humans. J of Clinical Investigation 2003 April;111(7):981-988.
Nig LL, Coppack SW, Zhang L, Hockaday TD. Application of minimal models to measuring insulin sensitivity. Horm Metab Res 1990;24(Suppl):57-59.
Nordquist L, Johansson M. Proinsulin C-peptide: Friend or foe in the development of diabetes-associated complications? Vascular Health and Risk Management 2008;4(6):1283-1288.
Noridian A29261: Chronic Intermittent Intravenous Insulin Therapy or Pulsatile IV Insulin Therapy. Article clarifying noncoverage of MAT. Jurisdiction: IA. Online at: http://www.cms.gov/MCD/m_a.asp?id=29261&ver=2&cid=00826
Noridian A28853: Chronic Intermittent Intravenous Insulin Therapy or Pulsatile IV Insulin Therapy. Article clarifying noncoverage of MAT. Jurisdiction: AL, AS, Guam, HI, NV, OR, WA, Northern Mariana Islands. Online at: http://www.cms.gov/MCD/m_a.asp?id=28853&ver=3&cid=00821
Noridian A27633: Chronic Intermittent Intravenous Insulin Therapy or Pulsatile IV Insulin Therapy. Article clarifying noncoverage of MAT. Jurisdiction: CO. Online at: http://www.cms.gov/MCD/m_a.asp?id=27633&ver=4&cid=00820.
Normedex Company Overview and PIVIT Insurance. Online at: http://www.normedex.com/normedex/contact.html; and http://www.normedex.com/normedex/treatment.html; and http://www.normedex.com/normedex/faq.html; and http://www.normedex.com/normedex/insurance.html; and http://www.normedex.com/normedex/diabetes.html; and http://www.normedex.com/normedex/company.html
O’Doherty RM, Lehman DL, Télémaque-Potts S, Newgard CB. Metabolic impact of glucokinase overexpression in liver: Lowering of blood glucose in red rats is accompanied by hyperlipidemia. Diabetes 1999 October;48:2022- 2027.
ODS Health Plan, Inc. Insulin Pumps. Most current Revision: August 2008 and approved by Csaba Mera, MD on January 18, 2008. Online at: http://www.odscompanies.com/pdfs/med_criteria/InsulinPumps.pdf.
Office of the Inspector General Letter. Glucose Monitoring. 1999. Online at: http://oig.hhs.gov/publications/docs/semiannual/1999/99semif.pdf; and http://oig.hhs.gov/oei/reports/oei-05-99-00380.pdf
Ohman JL Jr, Marliss EB, Aoki TT, Munichoodappa CS, Khanna VV, Kozak GP. The cerebrospinal fluid in diabetic ketoacidosis. NEJM 1971 Feb11;284(6):283-290.
Olson KR. Poisoning and drug overdose. Hyperkalemia and insulin. The McGraw-Hill Companies, Inc. 2007.
O’Rahilly S, Hosker JP, Rudenski AS, Matthews DR, Burnett, MA, Turner RC. The glucose stimulus-response curve of the ß-cell in physically trained humans, assessed by hyperglycemic clamps. Metabolism 1988 October;37(10):919-923.
O’Rahilly S, Trembath RC, Patel P, Galton DJ, Turner RC, Wainscoat JS. Linkage analysis of the human insulin receptor gene in Type 2 (non-insulin-dependent) diabetic families and a family with maturity onset diabetes of the young. Diabetologia 1988;31:792-797.
O’Rahilly S, Turner RC. Early-onset type 2 diabetes vs maturity-onset diabetes of youth: evidence for the existence of two discrete diabetic syndromes. Diabetic Medicine 1988;5:224-229.
O’Rahilly S, Turner RC. Linkage analysis of the receptor gene and MODY. Diabetologia 1988;31:184-187.
O’Rahilly S, Turner RC, Matthews DR. Impaired pulsatile secretion of insulin in reality? NEJM 1988 May 12;318(19):1225-1230.
O’Rahilly S, Wainscoat JS, Turner RC. Type 2 (non-insulin-dependent) diabetes mellitus. New genetics for old nightmares. Diabetologia 1998;31:407-414.
Orchard TJ, Costacou T, Kretowski A, Nesto RW. Type 1 diabetes and coronary artery disease. Diabetes Care 2006 November;29(11):2528-2538.
Overgaard RV, Jelic K, Karlsson M, Henriksen JE, Madesen H. Mathematical beta cell model for insulin secretion following IVGTT and OGTT. Annals of Biomed Engineering 2006;34(8):1343-1354.
Oxford – United Health Care. Policy Number: DIABETIC 017.1 T3. Effective: March 2009. Online at:
Paice BJ, Paterson KR, Onyanga-Omara F, Donnelly T, Gray JM, Lawson DH. Record linkage study of hypokalaemia in hospitalized patients. Postgrad Med J 1986 March;62(725):187-191.
Pal M. Recent advances in glucokinase activators for the treatment of type 2 diabetes. Drug Discovery Today 2009 August;14(15/16):784-792.
Palmetto GBA, MAC – Part B, Diabetes Mellitus Therapy Using Hepatic Activation or PIVIT Therapy (L28252). September 2, 2008. Online at:http://www.cms.gov/mcd/viewlcd.asp?lcd_id=28252&lcd_version=10&basket=lcd:28252:10:Diabetes+Mellitus+Therapy+Using+Hepatic+Activation+or+PIVIT+Therapy:MAC+-+Part+B:Palmetto+GBA+(01102):
Paolisso G, Salvatore T, Sgambato S, Torella R, Varricchio M, D’Onofrio F. Metabolic effects of pulsatile insulin infusion in the elderly. Endocrinol 1990 July;123(1):19-23.
Paolisso G, Scheen AJ, Albert A, and Lefebvre PJ. Effects of pulsatile delivery of insulin and glucagon in humans. Am J Physiol Endocrinol Metab 1989 November;257(20):E686-E696.
Paolisso G. Scheen AJ, Verdin EM, Luyckx AS, Lefebvre PJ. Insulin oscillations per se do not affect glucose turnover parameters in normal man. J Clin Endocrinol Metab 1986 August;63(2):520-525.
Paolisso G, Scheen AJ, Guigliano D, Sgambato S, Albert, A. Varricchio M, et al. Pulsatile insulin delivery has greater metabolic effects than continuous hormone administration in Man: importance of pulse frequency. J of Clin Endocrinol and Metab 1991 March;72(3):607-615.
Paolisso G, Sgambato S, Gentile S, Memoli P, Guigliano D, Varricchio M. Advantageous metabolic effects of pulsatile insulin delivery in noninsulin-dependent diabetic patients. J Clin Endocrinol Metab 1988 November;67(5):1005-1010.
Paolisso G. Sgambato S, Guinta R, Varricchio M, D’Onofrio F. Pulsatile rather than continuous glucagon infusion leads to greater metabolic derangements in insulin-dependent diabetic subjects. Diabete Metab 1990 Jan-Feb;16(1):42-47.
Paolisso G, Sgambato S, Passariello N, Scheen, A, D’Onofrio F, Lefebvre PJ. Greater efficacy of pulsatile insulin in type 1 diabetics critically depends on plasma glucagon levels. Diabetes 1987;36(5):566-570.
Paolisso G, Sgambato S, Torella R, Varricchio M, Scheen A.D’Onofrio F, et al. Pulsatile insulin delivery is more efficient than continuous infusion in modulating islet cell function in normal subjects and patients with type 1 diabetes. J Clin Endocrinol and Metab.1988;66(6):1220-1226.
Paolisso G, Sgambato S, Varricchio M, Scheen AJ, D’Onofrio F, Lefebvre. Insulin effects on glucose kinetics in non-insulin-dependent diabetic patients with secondary failure to hypoglycaemic agents: Role of different modes and rates of delivery. European J Medicine 1992;1(5)261-267.
Parrish DM. Correct Coding Initiative letter. Medically Unlikely Edit. July 30, 2009. (See (ACCPand ATS and CCI-Rosen). (Hardcopy available.)
Park RH, Hansell DT, Davidson LE, Henderson G, Legge V, Gray GR. Applied Nutritional Investigation. Management of diabetic patients requiring nutritional support. Nutrition 1992 September/October;8(5):316-320.
Payne VA, Arden C, Lange AJ, Agius L. Contributions of glucokinase and phosphofructokinase-2/fructose bisphosphatase-2 to the elevated glycolysis in hepatocytes from Zucker fa/fa rats. Am J Physiol Regulatory Integrative Comp Physiol 2007 August;293:618-625.
Perera NJ, Twigg SM, Williams PF, Chua EL, Stewart PM, Yue DK. The Danger of using inappropriate point-of-care glucose meters inpatients on Icodextrin dialysis. Department of Clinical Biochemistry, Royal Prince Alfred hospital, Sydney, Australia. Diabetes Centre, Department of Endocrinology, Royal Prince Alfred Hospital, 2009. Sydney, Australia. Discipline of Medicine, University of Sydney, Sydney, Australia. P1-459.
Pezzarossa A, Taddei F, Cimicchi MC, Rossini E, Contini S, Bonora E, et al. Perioperative management of diabetic subjects: Subcutaneous versus intravenous insulin administration during glucose-potassium infusion. Diabetes Care 1988;11:52-58.
Pickup JC, Mattock MB, Chusney GD, Burt D. NIDDM as a disease of the innate immune system: association of acute-phase reactants and interleukin-6 with metabolic syndrome X. Diabetologia 1997;40:1286-1292.
Pickup S, Popescu M. Efficient design of pulses with trapezoidal magnitude and linear phase response profiles. Magnetic Resonance in Medicine: official journal of the Society of Magnetic Resonance in Medicine 1997 Jul;38(1):137-145.
Pickup JC, Roberts GA, Kehely AM, Pasapula C, Chusney GD, Mather HM. Higher serum sialic acid in women than in men with NIDDM: Possible relevance to increased cardiovascular risk in NIDDM women. Diabetes Care 1997 September;20(9):1496.
Pinkos A, Arreaza-Rubin G, Heetderks WJ, Irony I, Joffe HV, Schneider B. FDA’s proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus. Drug Discovery today: Technologies. Elsevier 2007;4(1):25-28.
Piters KM, Kumar D, Pei E, Bessman AN. Comparison of continuous and intermittent intravenous insulin therapies for diabetic ketoacidosis. Diabetologia 1977;13:317-321.
Polak K,Dallinger, S, Polska, E, Findl O, Eichler HG, Wolzt M, et al. Effects of insulin on retinal and pulsatile choroidal blood flow in humans. Arch Opthamol 2000;118:55-59.
Polonsky KS. Comment regarding: Intermittent Insulin Therapy. Adolphus Busch Professor and Chairman, Department of Medicine, Director, Institute of Clinical and Translational Sciences, Washington University School of Medicine. August 4, 2009.
Polonsky KS. Lilly Lecture 1994. The beta-cell in diabetes: From molecular genetics to clinical research. Diabetes 1995 Jun;44(6);705-717.
Polonsky KS, Given BD, Hirsch LJ, Tillil H, Shapiro ET, Beebe C, et al. Abnormal patterns of insulin secretion in non-insulin-dependent diabetes mellitus. NEJM 1988 May 12;318(19):1231-1239.
Polonsky KS, Given BD, Prugh W, Licinio-Paixao J, Thompson JE, Karrison T, et al. Calculation of the systemic delivery rate of insulin in normal man. J Clin Endocrinol Metab 1986;63(1):113-118.
Polonsky KS, Sturis J, and Van Cauter E. Temporal profiles and clinical significance of pulsatile insulin secretion. Horm Res 1998;49(3-4):178-184.
Pomposelli JJ, Baxter JK III, Babineau TJ, et al. Early postoperative glucose control predicts nosocomial infection rate in diabetic patients. JPEN J Parenter Enteral Nutr 1998;22:77-81.
Pørksen N. The in vivo regulation of pulsatile insulin secretion. Diabetologia 2002 Jan;45(1):3-20.
Porksen N, Grofte T, Nyholm B, Holst JJ, Pincus SM, Veldhuis JD, et al. Glucagon-like peptide 1 increases mass but not frequency or orderliness of pulsatile insulin secretion. Diabetes 1998;47:45-49.
Pørksen N, Juhl C, Hollingdal M, Pincus SM, Sturis J, Veldhuis JD, Schmitz O. Concordant induction of rapid in vivo pulsatile insulin secretion by recurrent punctuated glucose infusions. Am. J. Physiol. (Endocrinol Metab) 2000;278:E162-E170.
Pørksen N, Munn S, Steers J, Vore S, Veldhuis J, Butler P. Pulsatile insulin secretion accounts for 70% of total insulin secretion during fasting. Am J Physiol. 269 (Endocrinol Metab) 1995 Mar 27;32:E478-488.
Pørksen N, Nyholm B, Veldhuis JD, Butler PC, Schmitz O. In humans at least 75% of insulin secretion arises from punctuated insulin secretory bursts. Am J Physiol Endocrinol Metab 1997 Jul 22;273:E908-E914.
Porte D Jr. Banting lecture 1990. Beta-cells in type II diabetes mellitus. Diabetes 1991 Feb;40(2):166-180.
Postic C, Shiota M, Magnuson MA. Cell-specific roles of glucokinase in glucose homeostasis. Recent Prog Horm Res 2001;56:195-217. Online at: http://www.rphr.endojournals.org
Pratley RE and Weyer C. Review. The role of impaired early insulin secretion in the pathogenesis of type II diabetes mellitus. Diabetologia 2001 Aug;44(8):929-945.
Prodo Labrotories, Inc. Irvine, California, United States. (Hardcopy available.) Online at: http://www.prodolabs.com/index.html.
Proposed decision by California Administrative Law Judge Steven A. Smith ordering CalPers to pay for Activation. This decision was voted on and approved by the CalPers Board. (Submitted April 20, 2009 with public comments via mail from Michael Bradley, Clinic Manager, Aoki Diabetes Research Institute.)
Public Law 105-33,105th Congress. H.R.2015 Balanced Budget Act of 1997. Online at: http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=105_cong_public_laws&docid=f:publ33.105
Pulse Medix. Online at: http://www.pulsemedics.com/
Radetti G, Ghizzoni L, Paganini C, Iughetti L, Caselli G, Bernasconi S. Insulin pulsatility in obese and normal prepubertal children. Horm Res 1998;50(2):78-82.
Ratzmann KF, Schultz B, Heinke P, Michaelis D. Quantitative and qualitative changes in early insulin response to glucose in subjects with impaired carbohydrate tolerance. Diabetes Care 1981;4:85-91.
Rave K, Heise T, Weyer C, Sawicki P, Heinemann L. Measurement of insulin sensitivity: Influence of potassium supply during euglycaemic glucose clamps in healthy volunteers. Exp Clin Endocrinol Diabetes 1999;107:313-317.
Regence Blue Cross and Blue Shield of Utah. Article for PIVIT, Metabolic Activation, or Hepatic Activation Therapy for Diabetes Mellitus (A27223). April 2, 2005. Online at: http://www.cms.gov/mcd/viewarticle_pdf.asp?article_id=27223&article_version=2&contractor_id=39
Ritz R. Resource management for noninvasive monitoring. Resp Care 1990 July;35:728-736.
Ritzel R, Schulte M, Porksen N, Nauck MS, Holst JJ, Juhl C, et al. Glucagon-like peptide 1 increases secretory burst mass of pulsatile insulin secretion in patients with type 2 diabetes and impaired glucose tolerance. Diabetes 2001;50:776-784.
Root HF, Carpenter TM. The effects of the dietary supply of carbohydrate upon the response of the human respiratory quotient after glucose administration. J of Nutrition 1944;333-341.
Rossini AA, Self J, Aoki TT, Goldman RF, Newmark SR, Meguid MM, et al. Metabolic and endocrine studies in a case of lipoatrophic diabetes. Metabolism 1977 Jun;26(6):637-650.
Saudek CD. Novel forms of insulin delivery. Endocrinology and metabolism Clinics of North America 1997 September;26(3):599-610.
Schmitz O, Arnfred J, Hielsen OH, Beck-Nielsen H, Orskov H. Glucose uptake and pulsatile insulin infusion: euglycaemic clamp and [3-3H] glucose studies in healthy subjects 1986 Dec;113(4):559-563.
Schmitz O, Pedersen SB, Mengel A, Pørksen N, Bak J, Møller N, et al. Augmented effect of short-term pulsatile versus continuous insulin delivery on lipid metabolism but similar effect on whole-body glucose metabolism in obese subjects. Metab 1994 Jul;43(7):842-846.
Scott D. Fisher A. The effect of zinc salts on the action of insulin. J. Pharmacol. Exp. Ther 1935;55: 206.
Scott JF, Robinson GM, French JM, O’Connell JE, Alberti KG, Gray CS. Glucose potassium insulin infusions in the treatment of acute stroke patients with mild to moderate hyperglycemia: the glucose insulin in stroke trial (GIST). Stroke 1999;30:793-799.
Scottish Intercollegiate Guideline Network (SIGN).
(The SIGN does not have any guidelines that address use of this therapeutic modality or the use of calorimetry in diabetic patients.)
(The SIGN has a single guideline regarding diabetes. Multiple other earlier guidelines on various aspects of diabetes were superseded by guideline #55.)
Management of Diabetes #55 (Issued 2001; reviewed 2005; need for update delineated)
Securities Exchange Commission (SEC). Amendment to Registration of Securities. Online at: http://www.secinfo.com/d11Eeb.4f896.htm; and http://www.secinfo.com/d11Eeb.4f89d.b.htm (See ADRI. See Diabetex.)
Seoane J, Gómez-Foix AM, O’Doherty RM, Gómez-Ara C, Newgard CB, Guinovart JJ. Glucose 6-Phosphate produced by glucokinase, but not hexokinase I, promotes the activation of hepatic glycogen synthase. J Biol Chem 1996 September 27;271(39):23756-23760.
Shah P, Vella A, Basu A, Basu R, Schaewk WF, Rizza RA. Lack of suppression of glucagon contributes to postprandial hyperglycemia in subjects with type 2 diabetes mellitus. J Clin endocrinol Metab 2000 Nov;85(11):4053-4059.
Shapiro ET, Tillil H, Rubenstein AH, Polonsky KS. Peripheral insulin parallels changes in insulin secretion more closely than C-peptide after bolus intravenous glucose administration. J Clin Endocrinolol Metab 1988;67(5):1094-1099.
Silverstein J, Klingensmith G, Copeland K, Plotnick L, Kaufman F, Laffel L, et al. Care of children and adolescents with type 1 diabetes: A statement of the American Diabetes Association. Diabetes Care. 2005. 28:186-212. Online at: http://care.diabetesjournals.org/content/28/1/186.full
Simmons D, Morton K, Laughton SJ, Scott DJ. A comparison of two intravenous insulin regimens among surgical patients with insulin-dependent diabetes mellitus. Diabetes Educ 1994 Sep-Oct;20(5):422-427.
Skyler JS, Bergenstal R, Bonow RO, Buse J, Deedwania P, Gale E, et al. Intensive glycemic control and the prevention of cardiovascular events: Implications of the ACCORD, ADVANCE, and VA diabetes trials. A position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Circulation 2009 Jan 20;119:351-357.
Smith CP, Tarn AC, Thomas JM, Overkamp D, Corakci A, Savage MO, et al. Between and within subject variation of the first phase insulin response to intravenous glucose. Diabetologia 1988 Feb;31(2):123-125.
Social Security Act, Section (§)1861(s)(2)(C) (diagnostic tests – other), a Part B benefit. Online at: http://www.ssa.gov/OP_Home/ssact/title18/1861.htm
Song, SH, McIntyre SS, Shah H, Veldhuis JD, Hayes PC, Butler PC. Direct measurement of pulsatile insulin secretion from the portal vein in human subjects. J Clin Endocrinol Metab. 2009 February 24;85(12):4491-4499.
Song H, Huewang L, Chuanyou Z, Min W. Glomerulosclerosis in Adriamycin-induced nephrosis is accelerated by a lipid-rich diet. Pediatr Nephrol 2000 July 14;15:196-200.
Stagner JI, Samols E, Weir GC. Sustained oscillations of insulin, glucagon, and somatostatin from the isolated canine pancreas during exposure to a constant glucose concentration. J Clin Invest 1980 Apr;65:939-942.
Strategic Partners – Bionica. (See VitalCare) (See Diabetes.net)Online at: http://www.vitalcaretechnology.com/Pdf/Strategic Partners feb2908.pdf
Sturis J, Polonsky KS, Shapiro ET, Blackman JD, O’Meara NM, Van Cauter E. Abnormalities in the ultradian oscillations of insulin secretion and glucose levels in type 2 (non-insulin-dependent) diabetic patients. Diabetologia 1992;35:681-689.
Takeuchi H, Inoue Y, Ishihara H, Oka Y. Overexpression of either liver type of pancreatic beta cell type glucokinase via recombinant adenovirus enhances glucose oxidation in isolated rat hepatocytes. FEBS Lett. 1996 September 9;393(1):60-64.
Talbot G.. Histology of Bowman’s membrane in cases of glaucoma. Br J Opthalmol 1938 Apr;22(4):210-214.
Tannenbaum GS, Martin JB, Colle E. Ultradian growth hormone rhythm in the rat: effects of feeding, hyperglycemia, and insulin-induced hypoglycemia. Endocrinol 1976 Sept;99(3):720-727.
Tattersall RB. A paper which changed clinical practice (slowly). Jacob Holler on potassium deficiency in diabetic acidosis (1946). Diabet Med 1999 Dec;16(12):978-984.
The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. NEJM 2008 Jun 12;358(2):2545-2559.
The Management of Diabetes Mellitus Working Group. VHA/DoD clinical practice guideline for the management of diabetes mellitus in the primary care setting. Contract number: V101(93)P-1633. 1999 December:(2.2).
Thorens B. GLUT2 in pancreatic and extra-pancreatic gluco-detection (review). Mol Membr Biol 2001 Oct-Dec;18(4):265-273.
Tilley JW. Glucokinase activators: Novo Nordisk’s WO2008084044 and Array Biopharma’s WO2008091770. Expert Opin Ther Pat 2009;19(4): 549-553.
Torres TP, Catlin RL, Chan R, Fujimoto Y, Sasaki N, Printz RL, et al. Restoration of hepatic glucokinase expression corrects hepatic glucose flux and normalizes plasma glucose in Zuker diabetic fatty rats. Diabetes 2009 January;58:78-86.
Torres N, Noriega L, Tovar AR. Nutrient Modulation of insulin secretion. Chapter nine. Vitamins and Hormones. Elsevier Inc., Amsterdam, The Netherlands. 2009;80:217-244.
Trivedi HS, Pang MM, Campbell A, Saab P. Slowing the progression of chronic renal failure: economic benefits and patients’ perspectives. Am J Kidney Dis 2002 Apr;39(4):721-729.
Truong MP, Arcangeli MA, Benbarka MM, Aoki TT, Grecu EO. The impact of Chronic Intermittent Intravenous Insulin Therapy (CIIIT) on blood pressure inpatients with IDDM and hypertension. Clin Res 1993;41:65A.
Tzamaloukas AH, Oreopoulos DG. Subcutaneous versus intraperitoneal insulin in the management of diabetics on CAPD: A review. Adv Perit Dial 1991;7:81-85.
Turnheim K, Waldhäusl WK. Essentials of insulin pharmacokinetics. Wien Klin Wochenshr 1988 Feb 5;100(3):65-72.
Uchino H, Niwa M, Shimizu T, Nishiyama K and Kawamori R. Impairment of early insulin response after glucose load, rather than insulin resistance, is responsible for postprandial hyperglycemia seen in obese type 2 diabetes: assessment using nateglinide, a new insulin secretagogue. Endocrine J 2000;47(5):639-641.
United Healthcare Diabetic 017.1 T3. Intermittent Intravenous Insulin Therapy. Noncoverage. Online at: https://www.oxhp.com/secure/policy/intermittent_iv_insulin_therapy_309.html
UK Prospective Diabetes Study (UKPDS) Group. [No authors listed]. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications inpatients with type 2 diabetes (UKPDS 33). Lancet 1998 Sept 12;352:837-853.
United Kingdom Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998 Sept 12;352:854-865.
United States (US) Patent 6582716 – Method for treating wounds, promoting healing and avoiding amputations in diabetic and non-diabetic patients. Inventor: Aoki, Thomas T. Online at: http://www.patentgenius.com/patent/6582716.html
United States (US) Patent 6967191. System for treating eye and nerve diseases in diabetic and non-diabetic patients. Inventor: Aoki, Thomas T. Publication Date: 11/22/2005. Filing Date 3/19/2003. Online at: http://www.freepatentsonline.com/6967191.html
Utilization (See CCI letter.) (See ATS/ACCP letter.)
Van Cauter E, Mestrez F, Sturis J, Polonsky KS. Estimation of insulin secretion rates from C-peptide levels: Comparison of individual and standard kinetic parameters for C-peptide clearance. Diabetes 1992;41(3):368-377.
Van den Berghe G, Wouters PJ, Bouillon R, et al. Outcome benefit of intensive insulin therapy in the critically ill: insulin dose versus glycemic control. Crit Care Med 2003 Feb;31(2):359-366.
Van Loan MD. Do hand-held calorimeters provide reliable and accurate estimates of resting metabolic rate? J Am College of Nutrition.2007;26(6):625-629.
Verdin E, Castillo M, Luyckx AS, Lefebvre P. Similar metabolic effects of pulsatile versus continuous human insulin delivery during euglycemic, hyperinsulinemic glucose clamp in normal man. Diabetes 1984 Dec;33(12):1169-1174.
Vessby B, Karlström B, Ohrvall M, Järvi A, Andersson A, Basu S. Diet, nutrition and diabetes mellitus. Ups J Med Sci 2000;105(2):151-160.
Vester JW, Reino ML. Hepatic Glucokinase: A direct effect of insulin. American Association for the Advancement of Science1963 November 1;142(3592):590-591.
Vetrans Health Administration (VHA)
(The VHA does not have any guidelines that address use of the outpatient intravenous insulin therapeutic modality or the use of calorimetry in diabetic patients.)
Vetrans Health Administration (VHA) Department of Defense (DoD)
Clinical Practice Guideline for the Management of Diabetes Mellitus in the Primary Care Setting: Vetrans Health Administration Department of Defense. 1999. Online at: http://www.google.com/search?q=VHA/DOD+Clinical+Practice+Guideline+for+the+management+of+Diabetes+Mellitus+in+the+Primary+Care+Setting
Vetrans Health Systems. Pulsatile insulin therapeutic program. (Personal communication with Dr. Leonard Pogach, Director, Vetrans Administration, New Jersey Healthcare System, Center for Healthcare Knowledge Management, March 2009.)
Vialetes B, Mattei-Zevaco C, Badier C, Ramahandridona G, Lassmann-Vague V, Vague PH. Low acute insulin response to intravenous glucose. A sensitive but non-specific marker of early stages of type 1 (insulin-dependent) diabetes. Diabetologia 1988 Aug;31(8):592-596.
Vinik. Office of Human Research Protection (OHRP) Sanction. Online at: http://www.hhs.gov/ohrp/detrm_letrs/YR06/jun06a.pdf
VitalCare. (See Inside Wall Street Report) (See Diabetes.net) (See Strategic Partners) Online at: http://vitalcaretechnology.com/strategic-partners.htm.
Vlachokosta FV, Asmal AC, Ganda OP, Aoki TT. The effect of strict control with the artificial beta-cell on plasma lipid levels in insulin-dependent diabetes. Diabetes Care 1983 Jul-Aug;6(4):351-355.
Ward GM, Marangou AG, Best JD, Aitken PM, Alford FP. Effects of short-term pulsatile and continuous insulin delivery on glucagon secretion and insulin secretion and action. Metab 1989 Apr;38(4):297-302.
Ward GM, Walters JM, Aitken PM, Best JD, Alford FP. Effects of prolonged pulsatile hyperinsulinemia in humans: Enhancement of insulin sensitivity. Diabetes 1990;39:501-507.
Watanabe RM, Volund A. Roy S. Bergman RN. Prehapeatic beta-cell secretion during the intravenous glucose tolerance test in humans: application of a combined model of insulin and C-peptide kinetics. J Clin Endocrinol Metab 1989 Oct;69(4):790-797.
Wathion N. Public statement on Exubera (Insulin Human) withdrawal of the marketing authorization in the European union. Drugs.com. London. November 10, 2008. Online at: http://www.drugs.com/news/public-statement-exubera-insulin-human-marketing-authorisation-european-union. 14661.html
Watkins K, Connell, CM. Measurement of health-related QOL in diabetes mellitus. PharmacoEconomics 2004;22(17):1109-1126.
Watkins P. Editor. The UKPDS: A model for gathering the evidence for the management of chronic diseases. J of the Royal College of Physicians of London 1998 November/December;32(6):510-511.
Webster GK, Bell RG. Gas chromatographic analysis of fosfomycin in plasma for pharmacokinetic analysis. J AOAC Int 1999 May-Jun;82(3):620-624.
Webster PA, King SE, Torres A. An in vitro validation of a commercially available metabolic cart using pediatric ventilator volumes. Pediatric Pulmonology 1998;26:405-411.
Wiederkehra, Wollheim CB. Impact of mitochrondrial calcium on the coupling of metabolism to insulin secretion in the pancreatic ß-cell. Cell Calcium.2008;44:64-76.
Weigle DS, Rumbaoa AV, Goodner CJ. Lack of evidence for improvement in long-term glycemic control by pulsatile insulin infusion in streptozocin-induced diabetic baboon. Diabetes 1991 Mar;40(3):349-357.
Weigle DS. Pulsatile secretion of fuel-regulatory hormones. Diabetes 1987 Jun;36(6):764-775.
Weinrauch LA, Bayliss G, Gleason RE, Lee aT, D’Elia JA. A pilot study to assess utility of changes in elements of the diabetes impact management scale in evaluating diabetic patients for progressive nephropathy. Metab Clin Exp 2009A;58:492-496.
Weinrauch LA, Bayliss G, Gleason RE, Lee AT, D’Elia JA. Utilization of an abbreviated diabetes impact management scale to assess change in subjective disability during a trial of pulsatile insulin delivery demonstrates benefit. Metab Clin Exp 2009B;58:488-491.
Weinrauch LA, Burger AJ, Aepfelbacher F, Lee AT, Gleason RE, Elia JA. A pilot study to test the effect of pulsatile insulin infusion on cardiovascular mechanisms that might contribute to attenuation of renal compromise in type 1 diabetes mellitus patients with proteinuria. Metab Clin Experimental 2007;56(11):1453-1457.
Weir JB. New methods for calculating metabolic rate with special reference to protein metabolism. Nutrition 1990 May-Jun; 6(3):213-221.
Wells C. Integrated Care. Emergency Ward Zen. Health Service Journal 1998 Nov 26;108(5632):32-33.
Wells JCK. Is obesity really due to high energy intake of low energy expenditure? International journal of Obesity 1998;22:1139-1140.
Wesson DE, Black PR, Vlachokosta F, Aoki TT, Wilmore DW. Artificial beta-cell promotes positive nitrogen balance and whole body protein synthesis in insulin-dependent diabetic subjects. JPEN J Parenter Enteral Nutr 1988 May-Jun;12(3):237-243.
Wilmshurst EG, Soeldner JS, Holsclaw DS, Kaufmann RL, Shwachman H, Aoki TT, et al. Endogenous and exogenous insulin responses in patients with cystic fibrosis. Pediatrics 1975 Jan;55(1):75-82.
Wolfsdorf JI, MB, BCh, Editor. Intensive diabetes management. 4th Edition. American Diabetes Association 2009.
Woolfson AM. Techniques, Materials, and Devices: An improved method for blood glucose control during nutritional support JPEN J Parenter Enteral Nutr 1981;5(5):436-440.
Woolfson AM. Control of blood glucose during nutritional support in ill patients. Intensive Care Med 1980;7:11-14.
Yadav N, Morris G, Harding WE, Ang S, Adams GG. Various non-injectable delivery systems for the treatment of diabetes mellitus. Endocr Metab Immune Disord Drug Targets 2009 Mar;9(1):1-13.
Žarkovic M, Ciric J, Penezic Z, Trbojevic B, Drezgic M. Effect of weight loss on the pulsatile insulin secretion. J of Clin Endocrinol Metab.2000 July 12;85(10):3673-3677.
Žarkovic M, Ciric J, Stojanovic M, Penezic Z, Trbojevic B, Drezgic M, et al. Effect of insulin sensitivity on pulsatile insulin secretion. European J of Endocrinol 1999;141:495-501.
Zerr KJ, Furnary aP, Grunkemeier GL, Bookin S, Kanhere V, Starr A. Glucose control lowers the risk of wound infection in diabetics after open heart operations. Ann Thorac Surg 1997;63:356-361.
Zhang Y. Predicting occurrences of acute hypoglycemia during insulin therapy in the intensive care unit. Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society, Conference. Vancouver, British Columbia, Canada. 2008 August 20;24:3297-3300.
Citations and Submissions by Commenters
American Association of Clinical Endocrinologists Report, 2007.
American Diabetes Association. Clinical Practice Recommendations 2003. Diabetes Care. 2003;26(Suppl 1).
American Diabetes Association Clinical Practice Recommendations.
Am.J Hypertension. 1995;8:782-789.
Am J Hypertension 1997;10:454-461.
Am J Cardiology. 1997;80: 1198-1202.
Am J Hypertension. 1998;11(3): 302-308.
Am J Hypertension 1999;12:1135-1139.
American Journal of Cardiology 1999;84:449-453.
American Journal of Cardiology 1999;84:687-691.
Aoki’s, M.D. Response to Blue Shield.
Aoki TT, Benbarka MM. Type I diabetes: An intensive approach to controlling blood glucose levels. Modern Medicine. 1992;60:88-103.
Aoki, TT, Benbarka MM. Type I diabetes: The ‘sleeping liver’ hypothesis and its clinical implications. Modern Medicine. 1992;60:73-76.
Aoki TT, Benbarka MM, Oklmura MC, Arcangeli MA, Walter RM, Wilson LD, et al. Long-term intermittent intravenous insulin therapy and type 1 diabetes mellitus. Lancet. 1993;342(8870):515-518.
Aoki TT, Grecu EO, Arcangeli MA. Chronic intermittent intravenous therapy corrects orthostatic hypotension of diabetes. Am J of Medicine. 1995;99(6):683-684.
Aoki TT, Grecu EO, Arcangeli MA. Effect of intensive intravenous insulin therapy on IGF-1 and IGFBP-1 blood levels inpatients with IDDM. J Investigative Med. 1997;45(1):135A.
Aoki TT, Grecu EO, Arcangeli MA. Reversal of severe nonschemic dilated cardiomyopathy by intensive intravenous insulin therapy in a patient with NIDDM. J Investigative Med. 1996;44(1): 126A.
Aoki TT, Grecu EO, Arcangeli MA, Benbarka MM, Prescott P, Ahn JH. Chronic intermittent intravenous insulin therapy: a new frontier in diabetes therapy. Diabetes Technol Ther. 2001. Spring; 3(1):111-123. Review.
Aoki TT, Grecu EO, Gollapudi GM, Barber, AR, Arcangeli MA, Benbarka MM, et. al. Effect of intensive insulin therapy on progression of overt nephropathy inpatients with type 1 diabetes mellitus. Endocrine Practice. 1999;5(4):174-178.
Aoki TT, Grecu EO, Meisenheimer. Effect of intensive insulin therapy of abnormal circadian blood pressure pattern inpatients with type 1 diabetes mellitus. Online J Curr Clin Trials; 1995. Dec 15; Doc No 199.
Aoki TT, Grecu EO, Prendergast JJ, Arcangeli MA, Meisenheimer R. Effect of chronic intermittent intravenous insulin therapy on antihypertensive medication requirement in IDDM subjects with hypertension and nephropathy. Diabetes Care. 1995;18(9):1260-1265.
Aoki TT, Viachokosta FV, Foss MC, Meistas MT. Evidence for restoration of hepatic glucose processing in type 1 diabetes mellitus. J Clin Invest. 1983;71(4):837-839.
Arch Int Med 2001;161:98-101.
Bando. Results of Clinical Trial of Five Patients Treated for One and a half Years With MAT™ Treatment. May 25, 2007. Fukui, Japan. English Translation Powerpoint.(on-line submission can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Dr Bando's Presentation JDA 25 May 2007 English.PPT)
Bass FM. "The adoption of a marketing model: Comments and observations". In V. Mahajan & Y. Wind (Eds.), Innovation Diffusion Models of New Product Acceptance. Cambridge, Mass.: Ballinger, 1986.
Blue Shield’s review of hepatic activation.
California Court of Appeals upholding the Superior Court decision.
Ca Public Employees’ Retirement System (CalPERS): Board of Administration. In the matter of the consolidated appeals of denial of coverage for hepatic activation treatment of: Names withheld (5). Case No.: 3490-5, 3490-3, 3490-2, 3490-1, 3490-4 and 3490-6.
CalPERS Court Ruling 2002. (on-line version submitted and can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\CalPers Decision 4 30 02.pdf)
CalPERS Proposed Decision 1.17.02 (on-line version submitted and can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\CalPers Proposed Decision 1 17 02.pdf)
CalPERS Judgement (on-line version submitted and can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\judgment.pdf)
CalPERS Order Re Legal Issues (on-line version submitted and can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\Order Re Legal Issues.pdf)
CalPERS Legal Issue 6 (on-line version submitted and can be found at: F:\My Projects\Diabetes\Metabolic Activated Therapy CAG 00410N\NCA\Calpers Decision\Order Legal Issue 6.pdf)
Christenson, C. The Innovator’s Dilemma: When new technologies cause great firms to fail. Harvard Business School Press 1997.
Dailey GE, Boden GH, Creech RH, Johnson DG, Gleason RE, Kennedy FP, et al. Effects of pulsatile intravenous insulin therapy (PIVIT) on the progression of diabetic nephropathy. Metabolism. 2000;49(11):1491-1495.
Field N, Boe N, Gilbert W, Benbarka M, Aoki T. The effect of chronic intermittent intravenous insulin therapy on pregnancy outcome in insulin dependent diabetes mellitus. J Soc Gynecol Invest. 1997;4(1, suppl): 196A.
Foss, MC, Vlachokosta FV, Cunningham LN, Aoki TT. Restoration of glucose homeostasis in insulin-dependent diabetic subjects. An inducible process. Diabetes. 1982;31(1):46-52.
Hayes Report, 2006.
Healthy People 2000 Review (1998-99). http://www.health.gov/healthypeople
Heinemann L. Comment regarding: Pulsatile Insulin Therapy. Profil Institute for Metabolic Resarch GmbH. Neuss, Germany. June 15, 2009.
Heinemann L, Sonnenberg GE, Hohmann A, Ritzenhoff A, Berger M, Benn J, et al. Pulsatile insulin infusion and glucose-homeostasis in well-controlled type 1 (insulin-dependent) diabetic patients. J Intern Med. 1989. Nov;226(5);325-333.
International Journal of Cardiology. 2002;86:281-287.
International Journal of Cardiology. 2004;94: 47-51.
Journal of Clinical Hypertension. 2005;7:159-164.
Journal of Clinical Hypertension. 2006;8:330-335.
Lew’s assessment of the statistical design of three studies on hepatic activation.
Logan-Darrough M. Pulsatile I.v. insulin therapy for severely out of control diabetes. J Intraven Nurs. 1995;May-Jun;18(3):124-128.
Meistas MT, Vlachokosta FV, Gleason RE, Arcangeli M, Aoki TT. Role of muscle in C02 production after oral glucose administration in man. Diabetes. 1985;34(10):960-963.
Metabolism. 2000. 49:88-91.
Milstein B, Jones A, Homer J. Charting Plausible Futures for Diabetes Prevalence in the United States: A Role for System Dynamics Simulation Modeling. Prev. Chronic Dis. 2007. July; 4(3):A52.
Mirbolooki M, Taylor GE, Knutzen VK, Scharp DW, Willcourt R, Lakey JRT. Pulsatile Intravenous Insulin Therapy: The Best Practice to Reverse Diabetes Complications? Medical Hypotheses. 2009 (In Press).
Moore G. Crossing the chasm: Marketing and selling high-tech products to mainstream customers (1991, revised 1999, 2000, 2001, 2002) New York: Harper Collins. Ohkubo(Japan).
Proposed decision by California Administrative Law Judge Steven A. Smith ordering CalPers to pay for Activation. This decision was voted on and approved by the CalPers Board.
Rogers EM. Diffusion of innovations (2003, 5th ed.). New York: Free Press.
Superior Court of California decision, ordering Blue Shield to pay for MAT therapy.
Trivedi HS, Pang MM, Cambell A, Saab P. Slowing the progression of chronic renal failure: economic benefits and patients’ perspectives. Am J Kidney Dis. 2002. 39(4):721-729.
Weinrauch LA, Bayliss G, Gleason RE, Lee AT, D"Elia JA. Utilization of an abbreviated diabetes impact management scale to assess change in subjective disability during a trial of pulsatile insulin delivery demonstrates benefit. Metabolism. 2009. 58(4):488-491.
Weinrauch LA, Bayliss G, Gleason RE, Lee AT, D"Elia JA. A pilot study to assess utility of changes in elements of the Diabetes Impact Management Scale in evaluating diabetic patients for progressive nephropathy. Metabolism. 2009. Apr;58(4):492-496.
Weinrauch LA, Burger A, Aepfelbacher F, Lee A, Gleason RE, D"Elia JA. A pilot study to test the effect of pulsatile insulin infusion on cardiovascular mechanisms that might contribute to attenuation of renal compromise in type 1 diabetes mellitus patients with proteinuria. Metabolism: Clinical and Experimental. 2007. 56(11):1453-1457.
WellPoint Medical Policy and Technology Assessment Committee (MPTAC) review of Chronic Intermittent Intravenous Insulin Therapy (CIIT), July 2008