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

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Karolinska Institute

Status

Completed

Conditions

Renal Failure
Stroke
Coronary Heart Disease

Treatments

Drug: Intensive insulin treatment
Drug: Standard insulin treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02138006
EPN-2012

Details and patient eligibility

About

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

Full 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.

Enrollment

102 patients

Sex

All

Ages

18 to 52 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Intensive insulin treatment
Experimental group
Description:
Intensive insulin treatment
Treatment:
Drug: Intensive insulin treatment
Standard insulin treatment
Active Comparator group
Description:
Standard insulin treatment
Treatment:
Drug: Standard insulin treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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