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NCT Number: NCT05594706

Anhydroglucitol in Children With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location status: Recruiting

Location contact

Philippe Klee, MD-PhD

CONTACT

[email protected]

+41 79 55 33 476

Philippe Klee, MD-PhD

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurement of blood levels of 1,5-anhydroglucitol

Other

Measurement of blood levels of 1,5-anhydroglucitol

Primary outcomes

  1. Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass

    Time frame: Day 1

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis

  2. Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass

    Time frame: 4 months after diagnosis

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis

  3. Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass

    Time frame: 12 months after diagnosis

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at different moments after diagnosis

  4. Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass

    Time frame: In participants with a disease duration of 3 years.

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration

  5. Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass

    Time frame: In participants with a disease duration of 5 years.

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration

  6. Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass

    Time frame: In participants with a disease duration of 10 years.

    Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function in patients with different disease duration

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Klee

CONTACT

[email protected]

+41 22 372 45 90

Pierre Maechler

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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