Biomarkers of Heterogeneity in Type 1 Diabetes (NCT04977635) | Clinical Trial Compass
CompletedNot Applicable
Biomarkers of Heterogeneity in Type 1 Diabetes
Netherlands611 participantsStarted 2016-06-08
Plain-language summary
Biomarkers of heterogeneity in type 1 diabetes: establishment of a biobank and an integrated approach to clinical and metabolic phenotyping of individuals with established T1DM. In this project the investigators are searching for biomarkers in 600 patients with established (\>5 years) diabetes. The inter-relation and patterns of expression in clinical, (auto)immune, metabolic, inflammatory and other parameters, and (potential) biomarkers are investogated. Blood and urine samples are collected annually (over 3 years) in standardized conditions and biobanked. In addition, 150 patients will undergo additional metabolic testing (such as mixed meal-tests).
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Type 1 diabetes determined by either autoantibodies or based on clinical and historical data or both
. At least 5 years (1825 days) of type 1 diabetes
. Minimum age 16 years
. Treated for type 1 diabetes at a diabetes center participating in this study
. Subject understands study protocol and agrees to comply with it and has been able to read the patient information sheet, has had time to ask questions and get answers and gives signed informed consent.
Exclusion criteria
. Non-type 1 diabetes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline remaining C-peptide production at 1 year and 2 years as measured by the Beckman ultrasensitive C-peptide assay
Timeframe: baseline, 1 year, 2 years
2
Change in prevalence of impaired awareness of hypoglycaemia between baseline and 2-year timepoint as measured by adapted Clarke hypoglycaemia awareness survey
Timeframe: baseline, 2 years
3
Genome-wide Association Study (GWAS) by Illumina 720k chip
Timeframe: cross-sectional: baseline
4
Assessment of glucagon response after stimulation with a mixed meal tolerance test as measured by the Mercodia glucagon assay (ELISA)
Timeframe: baseline
5
Change in patient-reported outcomes between baseline and 2 year timepoint as measured by WHO-5, PAID-20 and WHOQOL surveys