Implantable insulin pump vs multiple-dose insulin for non-insulin- dependent diabetes mellitus: A randomized clinical trial

JAMA

Volumn 276, Issue 16, 1996, Pages 1322-1327

  Saudek, Christopher D ^a,l   Duckworth, William C ^b   Giobbie Hurder, Anita ^c   Henderson, William G ^c   Henry, Robert R ^d   Kelley, David E ^e   Edelman, Steven V ^d   Zieve, Franklin J ^c   Adler, Robert A ^c   Anderson, James W ^f   Anderson, Robert J ^g   Hamilton, Bruce P ^h   Donner, Thomas W ^h   Kirkman, M Sue ^i,j   Morgan, Nancy A ^k  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^f UNIVERSITY OF KENTUCKY   (United States)

^g CREIGHTON UNIVERSITY   (United States)

^h UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

ⁱ DUKE UNIVERSITY   (United States)

^j INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k Ctrl Res Pharm Coord Center   (United States)

^l JOHNS HOPKINS HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; INSULIN; INSULIN ZINC SUSPENSION;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; DIABETES CONTROL; DOSE CALCULATION; GLUCOSE BLOOD LEVEL; HEALTH CARE QUALITY; HUMAN; HUMAN CELL; HUMAN TISSUE; INSULIN PUMP; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; SCORING SYSTEM; TREATMENT OUTCOME;

EID: 10244235261     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.276.16.1322     Document Type: Article

References (31)

1. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.
2. Blackshear PJ, Rohde TD, Prosl F, Buchwald J. The implantable infusion pump: a new concept in drug delivery. Med Prog Technol. 1979;6:149.
3. Irsigler K, Kritz H, Hagmuller G, et al. Long-term continuous intraperitoneal insulin infusion with an implantable remote-controlled insulin infusion device. Diabetes. 1981;30:1072-1075.
4. Point Study Group. One year trial of a remote-controlled implantable insulin infusion system in type 1 diabetic patients. Lancet. 1988;2:866-869.
5. Saudek CD, Selam J-L, Pitt HA, et al. A preliminary trial of the programmable implantable medication system for insulin delivery. N Engl J Med. 1989;321:574-579.
6. Saudek CD. Implantable insulin infusion pumps. Endocrinologist. 1993;3:15-20.
7. American Diabetes Association. Diabetes 1993 Vital Statistics. Alexandria, Va: American Diabetes Association; 1993:13-19.
8. Henry RR, Gumbiner B, Ditzler T, Wallace P, Lyon F, Glauber HS. Intensive conventional insulin therapy for type 1 diabetes: metabolic effects during a 6-month outpatient trial. Diabetes Care. 1993;16:21-31.
9. Saudek CD, Duckworth WC. The Department of Veterans Affairs Implantable Insulin Pump Study. Diabetes Care. 1992;15:567-570.
10. Saudek CD. Insulin infusion devices. In: Alberti KGMM, Krall LP, eds. The Diabetes Annual/ 6. New York, NY: Elsevier Science Inc; 1991:524-539.
11. Grau U, Saudek CD. Stable insulin preparation for implanted insulin pumps: laboratory and animal trials. Diabetes. 1987;36:1453-1459.
12. DCCT Research Group. Epidemiology of severe hypoglycemia in the Diabetes Control and Complications Trial. Am J Med. 1991;90:450-459.
13. DCCT Research Group. Reliability and validity of a diabetes quality of life measure for the Diabetes Control and Complications Trial (DCCT). Diabetes Care. 1988;11:725-732.
14. Blackshear PJ, Shulman GI, Roussell AM, et al. Metabolic response to three years of continuous, basal rate intravenous insulin infusion in type II diabetic patients. J Clin Endocrinol Metab. 1985; 61:753-780.
15. Duckworth WC, Saudek CD, Henry RR. Why intraperitoneal delivery of insulin with implantable pumps in NIDDM? Diabetes. 1992;41:667-671.
16. Laakso M, Ronnemaa T, Sarlund H, Pyorala K, Kallio V. Factors associated with fasting and postglucagon plasma c-peptide levels in middle-aged insulin-treated diabetic patients. Diabetes Care. 1989;12:83-88.
17. Brunzell JD, Robertson RP, Lerner RL, et al. Relationships between fasting plasma glucose levels and insulin secretion during intravenous glucose tolerance test. J Clin Endocrinol Metab. 1976; 42:222-229.
18. Klein R, Klein BEK, Moss SE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy, III: prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984;102:527-532.
19. Ballard DJ, Humphrey LL, Melton LJ III, et al. Epidemiology of persistent proteinuria in type II diabetes mellitus: population-based study in Rochester, Minnesota. Diabetes. 1988;37:405-412.
20. Reaven GM. Banting Lecture 1988: role of insulin resistance in human disease. Diabetes. 1988; 37:1595-1607.
21. Haffner SM, Valdez RA, Hazuda HP, Mitchell BD, Morales PA, Stern MP. Prospective analysis of the insulin-resistance syndrome (syndrome X). Diabetes. 1992;41:715-722.
22. Schade DS, Eaton RP, Davis T, et al. The kinetics of peritoneal insulin absorption. Metabolism. 1981;30:149-155.
23. Micossi P, Cristallo M, Librenti MC, et al. Free-insulin profiles after intraperitoneal, intramuscular, and subcutaneous insulin administration. Diabetes Care. 1986;9:575-578.
24. Yki-Jarvinen H, Kauppila M, Kujansuu E, et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. N Engl J Med. 1992;327:1426-1433.
25. Hepburn DA, MacLeod KM, Pell ACH, Scougel IJ, Frier BM. Frequency and symptoms of hypoglycemia experienced by patients with type 2 diabetes treated with insulin. Diabet Med. 1993;10: 231-237.
26. Cox DJ, Kovatchev BP, Julian DM, et al. Frequency of severe hypoglycemia in insulin-dependent diabetes mellitus can be predicted from self-monitoring blood glucose data. J Clin Endocrinol Metab. 1994;79:1659-1662.
27. Wing RR, Klein R, Moss SE. Weight gain associated with improved glycemic control in population-based sample of subjects with type 1 diabetes. Diabetes Care. 1990;13:1106-1109.
28. DCCT Research Group. Weight gain associated with intensive therapy in the Diabetes Control and Complications Trial. Diabetes Care. 1988;11: 567-573.
29. Carlson MG, Campbell PJ. Intensive insulin therapy and weight gain in IDDM. Diabetes. 1993; 42:1700-1707.
30. Haardt M-J, Dorange C, Selam J-L, et al. A cost-benefit comparison of intensive diabetes management with implantable pumps versus multiple subcutaneous injections in patients with type 1 diabetes. Diabetes Care. 1994;17:847-851.
31. DCCT Research Group. Resource utilization and costs of care in the Diabetes Control and Complications Trial. Diabetes Care. 1995;18:1468-1478.