Monitoring glucose levels to predict diabetes in at-risk individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: contact@bdronline.be
• Phone: 02 477 45 46

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• National Diabetes Management Program in China

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• Understanding the genetics of autoimmune responses in type 1 diabetes

  This study is trying to understand how genes and the environment affect the development of type 1 diabetes by looking at families with a history of the disease and healthy individuals.

  Recruiting Medical College of Wisconsin · Milwaukee, Wisconsin · NCT03648918

• Understanding extremely early-onset type 1 diabetes in infants

  This study looks at infants diagnosed with extremely early-onset type 1 diabetes to see how their immune systems and genes differ from those with typical diabetes, hoping to better understand this rare condition.

  Recruiting University of Exeter · Seattle, Washington and 3 other locations · NCT03369821

• How people with diabetes find and use health information in Reunion and mainland France

  This project will see how well people with type 1, type 2, or gestational diabetes in Reunion and France understand and use health information by having them complete a single health literacy questionnaire.

  Recruiting Centre Hospitalier Universitaire de la Réunion · Saint-Denis and 1 other locations · NCT06437782

• GLP-1 analogue treatment for obesity in young adults with type 1 diabetes

  This study is testing if a weight-loss medication can help young adults with type 1 diabetes and obesity improve their health over a year.

  Recruiting Phase 2 Yale University · New Haven, Connecticut · NCT06411210

• Behavioral approaches to reduce diabetes distress in adults with type 1 diabetes

  This study tests two different group programs to see if they can help adults with type 1 diabetes feel less stressed about managing their condition.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT06405373

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.