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

NCT ID: NCT02138006

Last Updated: 2016-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

1982-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease Stroke Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensive insulin treatment

Intensive insulin treatment

Group Type EXPERIMENTAL

Intensive insulin treatment

Intervention Type DRUG

Mealtime insulin (Actrapid) Basal insulin (Monotard)

Standard insulin treatment

Standard insulin treatment

Group Type ACTIVE_COMPARATOR

Standard insulin treatment

Intervention Type DRUG

Insulin Mixtard

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensive insulin treatment

Mealtime insulin (Actrapid) Basal insulin (Monotard)

Intervention Type DRUG

Standard insulin treatment

Insulin Mixtard

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Basal-bolus insulin treatment Mixed insulin 2-3 times per day

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Nystrom

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Nyström, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet Dept of clinical science and education Södersjukhuset Stocholm

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med. 1993 Jul 29;329(5):304-9. doi: 10.1056/NEJM199307293290502.

Reference Type BACKGROUND
PMID: 8147960 (View on PubMed)

Jensen-Urstad KJ, Reichard PG, Rosfors JS, Lindblad LE, Jensen-Urstad MT. Early atherosclerosis is retarded by improved long-term blood glucose control in patients with IDDM. Diabetes. 1996 Sep;45(9):1253-8. doi: 10.2337/diab.45.9.1253.

Reference Type BACKGROUND
PMID: 8772731 (View on PubMed)

Reichard P, Britz A, Cars I, Nilsson BY, Sobocinsky-Olsson B, Rosenqvist U. The Stockholm Diabetes Intervention Study (SDIS): 18 months' results. Acta Med Scand. 1988;224(2):115-22. doi: 10.1111/j.0954-6820.1988.tb16748.x.

Reference Type BACKGROUND
PMID: 3048052 (View on PubMed)

Reichard P, Pihl M. Mortality and treatment side-effects during long-term intensified conventional insulin treatment in the Stockholm Diabetes Intervention Study. Diabetes. 1994 Feb;43(2):313-7. doi: 10.2337/diab.43.2.313.

Reference Type BACKGROUND
PMID: 8288056 (View on PubMed)

Rathsman B, Jensen-Urstad K, Nystrom T. Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study. Diabetologia. 2014 Aug;57(8):1703-10. doi: 10.1007/s00125-014-3248-2. Epub 2014 May 7.

Reference Type BACKGROUND
PMID: 24802206 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EPN-2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Insulin Infusion Diabetes Ulcer
NCT00700154 TERMINATED NA
Fr1da Insulin Intervention
NCT02620072 COMPLETED PHASE2