Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this longitudinal clinical trial is to measure variability of interstitial glucose levels with a user-friendly real-time continuous glucose monitoring (CGM) technology at regular intervals in normo- and dysglycemic multiple autoantibody-positive individuals (age 5-39 years), in comparison with single autoantibody-positive individuals in the same age range. Participants will asked to undergo repeated oral glucose tolerance tests (OGTTs) (age 5-39 years) and hyperglycemic clamp tests (age 12-39 years) in parallel for a period of at least 2-3 years. In case of confirmed dysglycemia, we propose to perform CGM and OGTT every 3 months. The main questions the study aims to answer are: 1. Do the amplitude and time trends of CGM-derived glycemic variability indices and OGTT- and clamp-derived variables differ between the intermediate, high and very high risk groups? 2. Can (changes in) CGM-derived glycemic variability indices predict/detect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 4. Can correlating (changes in) CGM-derived indices with (changes in) OGTT- and clamp-derived variables help to better understand the sequence of events leading to dysglycemia and clinical onset, as well as the relative contribution of beta cell function and insulin action to glycemic variability according to disease stage and biological and phenotypical characteristics of the individuals?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 39
Healthy Volunteers: f
View:

• aged 5-39 years at inclusion;

• absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria;

• persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A.

Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Antwerp
A.Z. Sint-Jan Brugge
RECRUITING
Bruges
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Universitair Ziekenhuis Brussel
RECRUITING
Jette
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Clinique CHC MontLégia
RECRUITING
Liège
Contact Information
Primary
Belgian Diabetes Registry
contact@bdronline.be
02 477 45 46
Time Frame
Start Date: 2023-08-09
Estimated Completion Date: 2028-08
Participants
Target number of participants: 75
Treatments
Other: Autoantibody-positive individuals
Related Therapeutic Areas
Sponsors
Collaborators: Breakthrough T1D
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov