Actively Recruiting
A Randomized Controlled Trial of Three- and Seven-days Insulin Infusion Sets and Two Insulin Types on Skin Changes and Blood Sugar in Children and Adolescents With Type 1 Diabetes
Led by Steno Diabetes Center Copenhagen · Updated on 2024-08-06
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of different insulin infusion set wear times and insulin types on skin and glycemic outcomes in children and adolescents aged 7 to 18 with Type 1 Diabetes. This study compares wearing insulin infusion sets for three days versus seven days and examines if one type of insulin (insulin aspart - Novo Rapid or insulin lispro - Humalog) impacts the development of hyperechogenicity, a skin condition detected by ultrasound, as well as other skin changes like eczema. The study also explores how these factors influence blood sugar control and skin barrier health.
CONDITIONS
Brief Title
A Trial of Three- and Seven-days Insulin Infusions Set
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 1 Diabetes
- Diabetes duration of more than 6 months prior to inclusion
- Currently using the Medtronic 780G insulin pump system with automated insulin delivery or planning to use it
- Between 7 and 18 years of age prior to inclusion
- Insulin needs per day above 8 units
You will not qualify if you...
- Unable to read and understand Danish
- Impaired cognitive development that may interfere with answering questionnaires or being reached by phone or videocall
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 months
Participants use insulin infusion sets for 4 months followed by a crossover to the alternate infusion set for another 4 months, while using either Novorapid or Humalog insulin as assigned. The study compares 3-day versus 7-day infusion sets and two types of insulin on skin changes and blood sugar control.
Regular visits approximately every 2 weeks during each 4-month treatment period
Duration - Ongoing during treatment with some assessments repeated every 2 weeks
Participants undergo assessments including ultrasound, electric impedance spectroscopy, and tissue viability imaging to monitor skin changes and blood sugar control after treatment periods.
Approximately biweekly visits for assessments during treatment periods
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Copenhagen
Herlev, Capital, Denmark, 2730
Actively Recruiting
Research Team
J
Jannet Svensson, Professor
J
Julian Bjerrekær, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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