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 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.
- 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
- Observation: Cohort
- Perspective: Prospective
- Sampling: Probability Sample
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).
|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|