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Anhydroglucitol in Children With Type 1 Diabetes
NCT05594706 · University Hospital, Geneva
In plain English
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Official title
Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
About this study
One-center prospective exploratory pilot study performed in collaboration between the Pediatric Endocrine and Diabetology unit of the University Hospitals of Geneva (HUG) and Prof. Pierre Maechler, Diabetes Center of the Faculty of Medicine, University of Geneva Switzerland.
1,5-anhydroglucitol (1,5-AG), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. The decline of this biomarker precedes the development of hyperglycemia in lean b-Phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms.
Additional studies have shown a correlation of 1,5-AG levels with risk of progression of type 1 diabetes (T1DM) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes.
The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with T1DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T1DM.
Eligibility 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.
Study design
Enrollment target: 60 participants
Age groups: child, adult
Timeline
Starts: 2023-01-27
Estimated completion: 2026-12-31
Last updated: 2026-05-18
Interventions
Other: Measurement of blood levels of 1,5-anhydroglucitol
Primary outcomes
- • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass (Day 1)
- • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass (4 months after diagnosis)
- • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass (12 months after diagnosis)
Sponsor
University Hospital, Geneva · other
With: University of Geneva, Switzerland
Contacts & investigators
ContactPhilippe Klee · contact · philippe.klee@unige.ch · +41 22 372 45 90
ContactPierre Maechler · contact · pierre.maechler@unige.ch
All locations (1)
University Hospital of GenevaRecruiting
Geneva, Canton of Geneva, Switzerland