Condition: Type1 Diabetes Mellitus · Sponsor: Universitair Ziekenhuis Brussel
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 le…
This description comes directly from the study's public registry record.
Belgian Diabetes Registry · 02 477 45 46 · contact@bdronline.be
Always discuss trial participation with your own doctor first.
| Clinique CHC MontLégia | Liège, Liège, Belgium | Recruiting |
| A.Z. Sint-Jan Brugge | Bruges, West-Vlaanderen, Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen | Antwerp, Belgium | Recruiting |
| Universitair Ziekenhuis Gent | Ghent, Belgium | Recruiting |
| Universitair Ziekenhuis Brussel | Jette, Belgium | Recruiting |
| Universitair Ziekenhuis Leuven | Leuven, Belgium | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05777330