Actively Recruiting
Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes
Led by Steno Diabetes Center Copenhagen · Updated on 2025-06-03
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Steno Diabetes Center Copenhagen
Lead Sponsor
S
Steno Diabetes Center Sjaelland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating early signs of long-term complications in children and adolescents aged 6 to 18 years with type 1 diabetes (T1D) for more than 12 months. The study aims to understand how glucose control, glucose variability, and insulin sensitivity relate to early markers such as arterial stiffness, nerve dysfunction, and kidney changes. This research hopes to identify subgroups of young patients who may benefit from earlier screening and possible preventive measures to reduce complications and improve long-term health outcomes. The study is designed as a one-day cross-sectional visit where 400 participants will undergo thorough examinations after fasting overnight. Assessments include physical exams with heart and blood pressure checks, extensive blood sampling for metabolic markers, nerve function tests using non-invasive devices, kidney tests from urine samples, bone age X-rays, body composition scans, liver stiffness measurement, eye exams, and continuous glucose monitoring for at least 14 days. Physical activity will be tracked for 7 days, and questionnaires on lifestyle and quality of life will be completed. A subgroup of pubertal boys will have a special insulin sensitivity test using a hyperinsulinemic-euglycemic clamp. Participants will provide medical history including diabetes duration and treatment details. Researchers will collect data on past blood tests and diabetic complication status. Follow-up visits will be offered every 5 years for the next 20 years to monitor progression. The study measures arterial stiffness, nerve function, and other early complication markers and their relation to glucose control. Outcomes will help improve understanding of diabetes management and early detection of complications. The total participation involves a single detailed visit with extended monitoring and long-term follow-up opportunities.
CONDITIONS
Brief Title
Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 1 diabetes for more than 12 months
- Age between 6 and 18 years at the time of inclusion
- Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen
- Able to speak and read Danish well enough to understand oral and written information
- Written consent obtained from the child's guardian(s)
You will not qualify if you...
- Type 1 diabetes for less than 12 months
- Known cardiovascular disease
- Current treatment with antihypertensive medication
AI-Screening
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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 - 1 day
Participants attend a one-day visit after an overnight fast for a comprehensive set of examinations including physical exam, blood sampling, nerve function tests, kidney and bone assessments, liver elastography, eye exams, and extended lung function tests. Medical history and prior data are also collected.
1 visit (in-person)
Duration - 7 to 14 days
Participants wear a continuous blood glucose monitoring (CGM) device for at least 14 days to evaluate glucose variability, and physical activity is measured for 7 days with an AX3 device. Questionnaires on physical activity and life quality are also completed.
Wear CGM and physical activity devices for up to 14 days
Duration - Approximately 1 day
A subset of participants attend a second visit for a hyperinsulinemic-euglycemic clamp procedure performed in the morning after an overnight fast to directly measure insulin sensitivity through continuous insulin and glucose infusion.
1 additional visit (in-person) for selected participants
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Copenhagen
Herlev, Herlev, Denmark, 2730
Actively Recruiting
Research Team
J
Julie A Damm, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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