Monitoring glucose levels to predict diabetes in at-risk individuals

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

This study is testing if continuous glucose monitoring can help predict type 1 diabetes in young people who are at risk because they have certain antibodies in their blood.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 5 Years to 39 Years
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Locations: 6 sites (Liège, Liège and 5 other locations)
• Trial ID: NCT05777330 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to continuously monitor glycemic variability in individuals aged 5-39 years who are at risk for type 1 diabetes due to the presence of multiple autoantibodies. Participants will undergo regular continuous glucose monitoring (CGM) and oral glucose tolerance tests (OGTT) over a period of 2-3 years to assess their glucose levels and predict the onset of dysglycemia. The study will compare data from multiple autoantibody-positive individuals with those who are single autoantibody-positive to identify differences in glycemic variability. The goal is to enhance early diagnosis and intervention strategies for type 1 diabetes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 5-39 years who are persistently positive for one or more types of islet autoantibodies and do not meet the clinical criteria for diabetes.

Not a fit: Patients who are already diagnosed with diabetes or have a history of significant emotional or psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and intervention for individuals at high risk of developing type 1 diabetes, potentially preventing severe complications.

How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring for predicting diabetes onset, but this specific approach focusing on glycemic variability in asymptomatic individuals is relatively novel.

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.

Where this trial is running

Liège, Liège and 5 other locations

• 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)

Study contacts

• Principal investigator: Bart Keymeulen — Vrije Universiteit Brussel
• Study coordinator: Belgian Diabetes Registry

Conditions Type1 Diabetes Mellitus