Title

Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes
Stockholm Diabetes Intervention Study
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    insulin human ...
  • Study Participants

    102
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
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.
Study Started
Sep 30
1982
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Results Posted
Dec 21
2015
Estimate
Last Update
Oct 24
2016
Estimate

Drug Intensive insulin treatment

Mealtime insulin (Actrapid) Basal insulin (Monotard)

  • Other names: Basal-bolus insulin treatment

Drug Standard insulin treatment

Insulin Mixtard

  • Other names: Mixed insulin 2-3 times per day

Intensive insulin treatment Experimental

Intensive insulin treatment

Standard insulin treatment Active Comparator

Standard insulin treatment

Criteria

Inclusion Criteria:

Born 1930 or later
Type 1 diabetes
Nonproliferative retinopathy
Normal serum creatinine
Unsatisfactory blood glucose control

Exclusion Criteria:

Alcohol/drug abuse
Proliferative retinopathy

Summary

Intensive Insulin Treatment

Standard Insulin Treatment

All Events

Event Type Organ System Event Term

Cardiovascular Mortality

All cause mortality and composite mortality from myocardial infarction, stroke and renal failure

Intensive Insulin Treatment

7.0
participants

Standard Insulin Treatment

11.0
participants

Morbidity of Cardiovascular Complications

Morbidity of: coronary heart disease, stroke and renal failure

Intensive Insulin Treatment

6.0
participants

Standard Insulin Treatment

11.0
participants

Total

102
Participants

Age, Continuous

31
years (Mean)
Standard Deviation: 7

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Intensive Insulin Treatment

Standard Insulin Treatment