NCT05777330 Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
| NCT ID | NCT05777330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Type1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-08-09 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. aged 5-39 years at inclusion; 2. absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria; 3. persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A. Exclusion Criteria: 1. Pregnancy or lactation in women; \<6 months postpartum 2. Diabetes meeting the clinical diagnostic ADA criteria; 3. Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse; 4. Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders; 5. 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; 6. Gastric bypass or banding; 7. History of acute or chronic pancreatitis, or (partial) pancreatectomy 8. 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.
Contact & Investigator
Bart Keymeulen
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT05777330 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 39 Years, studying Type1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05777330 currently recruiting?
Yes, NCT05777330 is actively recruiting participants. Contact the research team at contact@bdronline.be for enrollment information.
Where is the NCT05777330 trial being conducted?
This trial is being conducted at Liège, Belgium, Bruges, Belgium, Antwerp, Belgium, Ghent, Belgium and 2 additional locations.
Who is sponsoring the NCT05777330 clinical trial?
NCT05777330 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Bart Keymeulen at Vrije Universiteit Brussel. The trial plans to enroll 75 participants.
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