Diabetes Mellitus, Type 1NCT05594706
Anhydroglucitol in Children With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Measurement of blood levels of 1,5-anhydroglucitol
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre Maechler contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, Canton of Geneva, 1211
Philippe Klee, MD-PhD, +41 79 55 33 476, philippe.klee@hcuge.ch
Philippe Klee, MD-PhD
About this study
Official title: Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Measurement of blood levels of 1,5-anhydroglucitol
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of blood levels of 1,5-anhydroglucitolOther
Measurement of blood levels of 1,5-anhydroglucitol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Measurement of blood levels of 1,5-anhydroglucitol | |
| 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. Receives: Other: Measurement of blood levels of 1,5-anhydroglucitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: In participants with a disease duration of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start27 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, Philippe Klee, MD-PhD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594706
- Sponsor's protocol ID
- 2022-01684
- Status last verified
- May 2026
- First submitted
- 29 Sep 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study
- ClinicalTrials.gov ID
- NCT05594706
- Acronym / sponsor ID
- 2022-01684
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed patients with T1DM | – | Other: Measurement of blood levels of 1,5-anhydroglucitolThe 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 | – | Other: Measurement of blood levels of 1,5-anhydroglucitolAs 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of blood levels of 1,5-anhydroglucitolMeasurement of blood levels of 1,5-anhydroglucitol | Other | Newly diagnosed patients with T1DM, Patients with T1DM of different duration |
Primary outcome
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Maechler contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Klee (+41 22 372 45 90, philippe.klee@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.