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

Type1 Diabetes Mellitus Clinical Trial

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

Clinical Trial 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 first-degree relatives (age 5-39 years) of type 1 diabetes patients, in comparison with single autoantibody-positive relatives 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) relatives 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 relatives 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 relatives?

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05777330
Study type Interventional
Source Universitair Ziekenhuis Brussel
Contact Belgian Diabetes Registry
Phone 02 477 45 46
Email contact@bdronline.be
Status Recruiting
Phase N/A
Start date August 9, 2023
Completion date April 2027
View Details
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