Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. The values will be compared to those obtained in healthy volunteers. Children with newly diagnosed diabetes as well as children with longstanding disease will be included. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in type 1 diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Switzerland
University Hospital of Geneva
RECRUITING
Geneva
Contact Information
Primary
Philippe Klee
philippe.klee@unige.ch
+41 22 372 45 90
Backup
Pierre Maechler
pierre.maechler@unige.ch
Time Frame
Start Date: 2023-01-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Newly diagnosed patients with T1DM
The investigators will do prospective measures in 10 to 15 children aged 2 to 18 years, at the time of diagnosis, four months after diagnosis and one year after diagnosis.
Patients with T1DM of different duration
As the functional beta-cell mass gradually declines as disease duration increases, the investigators will do measurements in a cohort of children aged ≤ 18 years, with increasing diabetes duration. The investigators plan to analyze groups of 5 patients with a disease duration of 3 (36 - 47 months), 5 (60 - 71 months) and 10 years (120 - 131 months), respectively.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Geneva
Collaborators: University of Geneva, Switzerland

This content was sourced from clinicaltrials.gov