Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings (NCT07627230) | Clinical Trial Compass
CompletedNot Applicable
Biomarkers of Type 1 Diabetes in Children and Their Healthy Siblings
Russia1,034 participantsStarted 2017-10-25
Plain-language summary
This prospective observational cohort study evaluated genetic, immunologic, and environmental factors associated with type 1 diabetes in children. Children with newly diagnosed type 1 diabetes and their healthy siblings were enrolled between October 2017 and June 2021. Data collection included HLA class I and class II genotyping, measurement of diabetes-associated autoantibodies to insulin (IAA), glutamic acid decarboxylase (GADA), insulinoma-associated antigen-2 (IA-2A), zinc transporter 8 (ZnT8A), and islet cell antibodies (ICA), as well as C-peptide and glycated hemoglobin (HbA1c). Healthy siblings underwent annual follow-up assessments for three years, while children with type 1 diabetes were evaluated every three months during the first year after diagnosis. Information on environmental risk factors was collected using an investigator-developed questionnaire based on anamnestic data. The study aimed to identify biomarkers and risk factors associated with the development and progression of type 1 diabetes in children.
Who can participate
Age range
4 Months – 29 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:
* For children with newly diagnosed type 1 diabetes:
Age 0 to 17 years, inclusive; Diagnosis of type 1 diabetes mellitus established according to World Health Organization (WHO) diagnostic criteria applicable during the study period.
For healthy siblings:
Biological brothers or sisters of a participant with type 1 diabetes mellitus; Absence of laboratory criteria for type 1 diabetes at enrollment, including blood glucose and glycated hemoglobin (HbA1c) values below diagnostic thresholds for type 1 diabetes.
For all participants:
Written informed consent obtained from parents or legal guardians prior to study enrollment.
Exclusion Criteria:
* Monogenic diabetes mellitus; Secondary diabetes mellitus; Refusal or withdrawal of informed consent.
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.
1This study looked at biomarkers in children with Type 1 diabetes and their healthy siblings to build a prediction model — does my child's sibling qualify to have those kinds of biomarkers checked, and is that type of screening something you'd recommend for our family now?
2Since this trial is already completed, have the results been published yet, and could you help me understand whether the prediction model they developed might be relevant to assessing my child's risk?
3The study focused on healthy siblings of children with Type 1 diabetes — based on our family history, do you think my child falls into a higher-risk group that warrants closer monitoring for early signs of the disease?
4Are there currently any open follow-up studies or similar biomarker screening programs you'd suggest we look into, given that this particular trial has already finished enrolling?
5If a prediction model like the one this study aimed to develop were available, how would a positive result actually change our monitoring plan or treatment decisions going forward?
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
Development of a Prediction Model for Type 1 Diabetes in Healthy Siblings