Intensified insulin treatment
DrugThe treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
Other names: Monotard; Actrapid
NCT Number: NCT01957930
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).
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden
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 randomiz (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 study, 96 patients from the SDIS study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35 vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). All participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.
The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
Other names: Monotard; Actrapid
Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
Other names: Premixed Insulin
Time frame: Until hospitalization for ischemic foot ulcer or until 31 December 2011
The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code
Time frame: 7 years
Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.
Karolinska Institutet
Other
Intensified Insulin Treatment and Skin Microcirculation; Its Relation to Ischemic Foot Ulcer in Patients With Type 1 Diabetes Mellitus: A Long-term Follow-up Study
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