Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-01-27
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Measurement of blood levels of 1,5-anhydroglucitol
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.
Measurement of blood levels of 1,5-anhydroglucitol
Measurement of blood levels of 1,5-anhydroglucitol
Interventions
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Measurement of blood levels of 1,5-anhydroglucitol
Measurement of blood levels of 1,5-anhydroglucitol
Eligibility Criteria
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Inclusion Criteria
* 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 changing the type of CGMS during the course of the study.
2 Years
18 Years
ALL
Yes
Sponsors
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University of Geneva, Switzerland
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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Philippe Klee, MD-PhD
Principal investigator
Locations
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University Hospital of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-01684
Identifier Type: -
Identifier Source: org_study_id
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