NCT01957930

Brief Summary

We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1984

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1984

Completed
27.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 21, 2015

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

27.9 years

First QC Date

October 4, 2013

Results QC Date

November 16, 2015

Last Update Submit

September 28, 2020

Conditions

Ischemic Foot Ulcer

Keywords

HbA1cIontophoresisIntensified insulin treatmentIschemic foot ulcerType 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Ischemic Foot Ulcer

    The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code

    Until hospitalization for ischemic foot ulcer or until 31 December 2011

Other Outcomes (1)

  • Microvascular Endothelial Function

    7 years

Study Arms (3)

Intensified insulin treatment

EXPERIMENTAL

Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day

Drug: Intensified insulin treatment

Standard treatment

ACTIVE COMPARATOR

Mixed Insulin (2-3 times a day)

Drug: Standard treatment

Healthy controls

NO INTERVENTION

These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-

Interventions

Intensified insulin treatmentDRUG

The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.

Also known as: Monotard; Actrapid
Intensified insulin treatment
Standard treatmentDRUG

Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Also known as: Premixed Insulin
Standard treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Born 1930 or later, Type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients.

You may not qualify if:

  • Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Stockholm, 118 83, Sweden

Location

Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB

Stockholm, 118 83, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 3048052BACKGROUND

  • 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.

    PMID: 8147960BACKGROUND

  • 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.

    PMID: 24802206DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Thomas Nyström
Organization
Karolinska Institutet Södersjukhuset
thomas.nystrom@sodersjukhuset.se
+46704325214

Study Officials

  • Thomas Nyström, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 4, 2013

First Posted

October 8, 2013

Study Start

January 1, 1984

Primary Completion

December 1, 2011

Study Completion

June 1, 2013

Last Updated

September 29, 2020

Results First Posted

December 21, 2015

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)