NCT05777330Recruiting
Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 8 Mar 2023
- Start date
- 9 Aug 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Type 1 diabetes
- NCT number
- NCT05777330
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 9 Aug 2023 to the primary completion date, 30 Nov 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with immune modulating or diabetogenic medication (e.g. corticosteroids) or medication that act to lower glycemia (oral antidiabetics) or agents that may influence insulin sensitivity or secretion;
Other illness
- Diabetes meeting the clinical diagnostic ADA criteria;
- Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse;
- Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders;
- History of acute or chronic pancreatitis, or (partial) pancreatectomy
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects.
Other
- Pregnancy or lactation in women; \<6 months postpartum
- Gastric bypass or banding;
Who the study is looking for
- 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.
Age in the registry: 5 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| A.Z. Sint-Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Universitair Ziekenhuis Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Clinique CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.