NCT02138006

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

Stockholm Diabetes Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease
• Stroke
• Renal Failure

Interventions

Type	Name	Description
DRUG	Intensive insulin treatment	Mealtime insulin (Actrapid) Basal insulin (Monotard)
DRUG	Standard insulin treatment	Insulin Mixtard

Timeline

• Start date: 1982-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2014-05-14
• Last updated: 2016-10-24
• Results posted: 2015-12-21

Locations

1 site across 1 country: Sweden