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

Not Applicable

Completed

• Conditions: Renal Failure; Coronary Heart Disease; Stroke
• Interventions: Drug: Intensive insulin treatment; Drug: Standard insulin treatment

• Registration Number: NCT02138006
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 1982-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Results First Submitted: 2015-11-16
• Results First Submitted QC: 2015-11-16
• Results First Posted: 2015-12-21
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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Exclusion Criteria

• Alcohol/drug abuse
• Proliferative retinopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive insulin treatment	Intensive insulin treatment	Intensive insulin treatment
Standard insulin treatment	Standard insulin treatment	Standard insulin treatment

Primary Outcome Measures

Name	Time	Method
Cardiovascular Mortality	Up to 28 years	All cause mortality and composite mortality from myocardial infarction, stroke and renal failure

Secondary Outcome Measures

Name	Time	Method
Morbidity of Cardiovascular Complications	Up to 28 years	Morbidity of: coronary heart disease, stroke and renal failure

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden