Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes "SDIS"

Completed

Phase N/A Results

Trial Description

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 observational 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.

Conditions

Interventions

  • Intensive insulin treatment Drug
    ARM 1: Kind: Experimental
    Label: Intensive insulin treatment
    Description: Intensive insulin treatment
  • Standard insulin treatment Drug
    ARM 1: Kind: Experimental
    Label: Standard insulin treatment
    Description: Standard insulin treatment

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

A total of 102 patients with type 1 diabetes mellitus were randomised to ICT (n=48) or ST (n=54) with insulin between September 1982 and March 1984. The original SDIS study lasted for an average of 7.5 years and ceased in 1990, by which time 96 patients had been fully evaluated. Thereafter, all patients were assigned to their regular clinical visits, mainly at one hospital (Södersjukhuset, Stockholm, Sweden).

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular mortality Up to 28 years No
Secondary Morbidity of cardiovascular complications (i.e. coronary heart disease and stroke) and renal failure Up to 28 years No

Sponsors