Skip to main content
OpenTrials
Completed

NCT Number: NCT02138006

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

To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Heart Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Nervous System Diseases Renal Failure Renal Insufficiency Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södersjukhuset

Stockholm, 11883, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive insulin treatment

Drug

Mealtime insulin (Actrapid) Basal insulin (Monotard)

Other names: Basal-bolus insulin treatment

Standard insulin treatment

Drug

Insulin Mixtard

Other names: Mixed insulin 2-3 times per day

Primary outcomes

  1. Cardiovascular Mortality

    Time frame: Up to 28 years

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

Secondary outcomes

  1. Morbidity of Cardiovascular Complications

    Time frame: Up to 28 years

    Morbidity of: coronary heart disease, stroke and renal failure

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Stockholm Diabetes Intervention Study

Acronym: SDIS

Important dates

Study start
1982
Primary completion
2011
Study completion
2011
First posted
May 14, 2014
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.