Anhydroglucitol in Children With Type 1 Diabetes
Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedStudy Start
First participant enrolled
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 18, 2026
May 1, 2026
3.9 years
September 29, 2022
May 14, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
Day 1
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
4 months after diagnosis
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis
12 months after diagnosis
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
In participants with a disease duration of 3 years.
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
In participants with a disease duration of 5 years.
Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration
In participants with a disease duration of 10 years.
Study Arms (2)
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.
Interventions
Measurement of blood levels of 1,5-anhydroglucitol
Eligibility Criteria
Among children with type 1 diabetes, aged 2 to 18 years: 15 newly diagnosed patients and 15 age- and sex-matched controls. 5 patients with a diabetes duration of 3 (36 - 47 months), 5 patients with a disease duration of 5 (60 - 71 months) and 5 patients with a disease duration of 10 years (120 - 131 months) and 15 corresponding age- and sex-matched controls.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Geneva, Switzerlandcollaborator
- University Hospital, Genevalead
Study Sites (1)
University Hospital of Geneva
Geneva, Canton of Geneva, 1211, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 29, 2022
First Posted
October 26, 2022
Study Start
January 27, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 18, 2026
Record last verified: 2026-05