The Minnesota diabetes complications clinical trial the first three years

Abstract

A prospective and randomized clinical trial of an inception cohort of diabetic kidney recipients to test the hypothesis that maximized metabolic control of diabetes prevents or delays diabetic nephropathy in the renal allografts was initiated approximately three years ago. Notwithstanding the fact that all our diabetic patients were on prednisone and therefore metabolically unstable, we achieved and maintained a clear difference between the standard control (group A) and the maximized control patients (group B). At 13 months of study, the mean fasting blood glucose mg% (A: 242 +/- 22, B: 130 +/- 9, p less than 0.001), nonfasting blood glucose (A: 276 +/- 40, B: 135 +/- 10, p less than 0.001), 24 hour urine glucose (A: 85 +/- 16, B: 5 +/- 1, p less than 0.001), and glycosylated hemoglobin % (A: 13 +/- 0.9, B: 10 +/- 0.8, p less than 0.01) were all clearly and statistically significantly higher for the group A patients. These results show the feasibility of such a trial using the tools available today to treat diabetes.

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials

“…We excluded 42 references after further evaluation. The main reasons for exclusion were that the trial was not randomised (11 references),31 32 33 34 35 36 37 38 39 40 41 participants were not patients with type 2 diabetes or we could not separate data on patients with type 2 diabetes (four references),42 43 44 45 or no predefined differences in glycaemic intervention target existed (16 references) 4647 48 49 50 51 52 53 54 55 56 57 58 59 60 61 In addition, we excluded trials that assessed intensive glycaemic control as a part of an acute intervention (five references, three trials) or had concomitant targeting of several cardiovascular risk factors in the glycaemic intervention arm (six references, three trials) 16…”

Severe Hypoglycemia During Maximized Insulin Treatment of Diabetes in a Randomized Clinical Trial

“…We report here the serious consequences of hypoglycemia experienced by five diabetic patients, participants in the Minnesota Diabetes Complications Clinical Trial (MDCT), which tests in a randomized group of diabetic kidney recipients the hypothesis that "maximized" blood glucose control prevents or delays the development of diabetic nephropathy in renal allografts. 4 The patients were insulindependent with duration of disease of 13 yr or longer, metabolically unstable and on prednisone (as immunosuppression therapy), and all had been randomized to the maximized metabolic control group. Although approximately 40% of our patients in this group are treated with insulin pump, none of the patients described were on an insulin pump.…”