Measuring a new biomarker in children with type 1 diabetes
Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
This study is testing a new blood marker in children with type 1 diabetes to see if it can help measure how well their insulin-producing cells are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT05594706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure blood levels of 1,5-anhydroglucitol in children diagnosed with type 1 diabetes and correlate these levels with indicators of functional beta-cell mass. The study will include both newly diagnosed and long-standing cases of diabetes, comparing results with healthy volunteers. Conducted at the University Hospital of Geneva, the research seeks to validate 1,5-anhydroglucitol as a potential biomarker for assessing beta-cell function in pediatric patients with type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates are children with type 1 diabetes who are positive for specific autoantibodies and are using continuous subcutaneous insulin infusion.
Not a fit: Patients treated with multiple daily injections or those unwilling to use continuous glucose monitoring systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for monitoring beta-cell function in children with type 1 diabetes, potentially improving management and treatment strategies.
How similar studies have performed: Previous studies have shown correlations between 1,5-anhydroglucitol levels and diabetes progression, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)8. * Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery (AID). * Monitoring with a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM). * Patient willing to keep the same type of CGMS or FGM during the year of observation * Ability to give informed consent as documented by signature Exclusion Criteria: * Patients treated with multiple daily injections (MDI) or not willing to wear a CGMS of FGM * Patients changing the type of CGMS during the course of the study.
Where this trial is running
Geneva, Canton of Geneva
- University Hospital of Geneva — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Philippe Klee
- Email: philippe.klee@unige.ch
- Phone: +41 22 372 45 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.