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Anhydroglucitol in Children With Type 1 Diabetes

ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Measurement of blood levels of 1,5-anhydroglucitol

    Other intervention

    Measurement of blood levels of 1,5-anhydroglucitol

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Newly diagnosed patients with T1DM1 intervention
Group B: Patients with T1DM of different duration1 intervention

Trial outcomes

Primary outcomes

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

Time frame
Day 1
2

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

Time frame
4 months after diagnosis
3

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

Time frame
12 months after diagnosis
4

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

University of Geneva, Switzerland

Collaborator

Source ClinicalTrials.gov
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