Conditions: Coronary Heart Disease Stroke Renal Failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief summary:
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

Detailed description:
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.

Arms:
arm 1: Intensive insulin treatment arm 2: Standard insulin treatment

Interventions: intervention 1: Intensive insulin treatment intervention 2: Standard insulin treatment
Intervention descriptions: intervention 1: Mealtime insulin (Actrapid) Basal insulin (Monotard) intervention 2: Insulin Mixtard

Protocol document: