Actively Recruiting

Age: 2Years - 18Years
All Genders
Healthy Volunteers
ID05594706

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

Led by University Hospital, Geneva · Updated on 2026-05-18

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Geneva

Lead Sponsor

U

University of Geneva, Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the blood levels of 1,5-anhydroglucitol (1,5-AG) in children with type 1 diabetes to see how these levels relate to the function and mass of insulin-producing beta cells. This study includes children newly diagnosed with diabetes as well as those with longstanding disease, comparing their results to healthy volunteers. The goal is to evaluate 1,5-AG as a new biomarker for assessing beta-cell health in type 1 diabetes. The study involves measuring 1,5-AG levels in groups of children aged 2 to 18 years. For newly diagnosed patients, measurements will be taken at diagnosis, then again four months and one year later. For children with longer disease duration, groups with 3, 5, and 10 years of diabetes will be assessed. These prospective measurements aim to track changes in beta-cell function over time. Participants will have blood tests at the specified time points to measure 1,5-AG and compare it with indirect markers of beta-cell function and mass. Data will be collected in a one-center setting, with children monitored using continuous or flash glucose monitoring systems. The study will evaluate correlations at diagnosis and during follow-up, helping to explore the potential of 1,5-AG as a biomarker in diabetes management.

CONDITIONS

Brief Title

Anhydroglucitol in Children With Type 1 Diabetes

Who Can Participate

Age: 2Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 18 years
  • Diagnosis of type 1 diabetes with positive autoantibodies against islets, insulin, IA2, GAD65, or ZnT8
  • Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery
  • Use of a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM)
  • Willingness to keep the same type of CGMS or FGM during the year of observation
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Patients treated with multiple daily injections (MDI) or unwilling to wear a CGMS or FGM
  • Patients changing the type of CGMS during the course of the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months for newly diagnosed patients; single assessments for patients with longstanding disease

Participants provide blood samples to measure levels of 1,5-anhydroglucitol and other indirect markers of beta-cell function and mass at various time points depending on their disease duration.

For newly diagnosed patients: 3 visits at diagnosis, 4 months, and 12 months; for longstanding disease cohorts: 1 visit per disease duration group

Trial Site Locations

Total: 1 location

1

University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland, 1211

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Research Team

P

Philippe Klee

P

Pierre Maechler

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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