Comparing three-day and seven-day insulin infusion sets for children with Type 1 Diabetes
Official title: A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes
Run by Steno Diabetes Center Copenhagen · NCT06532461 · Data updated 2026-11-12
This study tests whether using insulin infusion sets for three days or seven days helps kids with Type 1 Diabetes avoid skin problems and works better with different types of insulin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 18 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev, Capital) |
| Status | Recruiting |
| Started | July 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 6, 2024 |
| Trial ID | NCT06532461 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 7 to 18 years with Type 1 Diabetes who have been using a hybrid closed-loop insulin delivery system for at least six months.
✕Probably not a fit
Patients who cannot read or understand Danish or have cognitive impairments that affect their ability to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of using three-day versus seven-day insulin infusion sets in children and adolescents with Type 1 Diabetes. It aims to determine which duration of infusion set use is more effective in preventing skin complications such as hyperechogenicity and eczema. Participants will be using the Medtronic 780G hybrid closed-loop system, and the study will also compare the effects of two types of insulin: Novorapid and Humalog. The research will involve monitoring skin conditions and insulin absorption over the specified periods.
Why it matters
Potential benefit: If successful, this study could lead to improved skin health and insulin absorption for children and adolescents using insulin pumps.
How similar studies have gone: Previous studies have shown varying results regarding insulin absorption and skin complications with different infusion set durations, making this approach both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with T1D * Diabetes duration of more than 6 months prior to inclusion. * Currently using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery. * Planning to using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery. * Being between 7 and 18 years of age prior to inclusion * Insulin needs per day above 8 units Exclusion Criteria: * Those who are unable to read and understand Danish * Those with impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and/or be reached by phone or videocall
Where it's running
-
Steno Diabetes Center Copenhagen
Herlev, Capital, Denmark Recruiting
Study contacts
- Principal investigator: Jannet Svensson — Steno Diabetes Center Copenhagen
- Study coordinator: Jannet Svensson, Professor
- Email: jannet.svensson@regionh.dk
- Phone: 25488355
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.