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Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes 75

Recruiting
Clinical Trial NCT05777330 is an interventional study for Type1 Diabetes Mellitus that is recruiting. It started on 9 August 2023 with plans to enroll 75 participants. Led by Universitair Ziekenhuis Brussel, it is expected to complete by 1 August 2028. The latest data from ClinicalTrials.gov was last updated on 2 September 2025.
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 ...Show More
Detailed Description
Type 1 diabetes is a for now incurable disease caused by a major immune-mediated loss of insulin-producing pancreatic beta cells, can lead to potentially severe acute and chronic complications and requires a lifelong insulin treatment. Clinical onset of type 1 diabetes is preceded by an asymptomatic disease phase of highly variable duration, which is signaled by the presence of multiple (≥2) types of islet autoantibo...Show More
Official Title

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

Conditions
Type1 Diabetes Mellitus
Other Study IDs
  • PredicT1D
NCT ID Number
NCT05777330
Start Date (Actual)
2023-08-09
Last Update Posted
2025-09-02
Completion Date (Estimated)
2028-08
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Screening
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherAutoantibody-positive individuals
Oral glucose tolerance test (OGTT)
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes. OGTT is performed every 6 months (every 3 months in case of dysglycemia) in all participants.
Hyperglycemic clamp test
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes. Clamp test is performed every 12 months in single autoantibody-positive participants and every 6 months in multiple autoantibody-positive participants. Clamp tests are not performed i...Show More
Continuous glucose monitoring
Longitudinal study using repeated OGTT, CGM and hyperglycemic clamp tests to evaluate glycemic variability, beta cell function and insulin action in individuals at moderate, high and very high risk of clinical onset of type 1 diabetes. A 10-day CGM recording is performed every 6 months (every 3 months in case of dysglycemia) in all participants.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression to persistent dysglycemia
In initially normoglycemic (single or multiple) autoantibody-positive individuals
2-3 years
Progression to persistent dysglycemia and stage 3 type 1 diabetes
In all multiple autoantibody-positive individuals
2-3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
5 Years
Eligible Sexes
All
  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.

  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.
Universitair Ziekenhuis Brussel logoUniversitair Ziekenhuis Brussel
Breakthrough T1D logoBreakthrough T1D
Study Central Contact
Contact: Belgian Diabetes Registry, 02 477 45 46, [email protected]
6 Study Locations in 1 Countries

Liège

Clinique CHC MontLégia, Liège, Liège, 4000, Belgium
Alexandra Van Eyck, Contact, 04 355 42 14, [email protected]
Nicole Seret, MD, Principal Investigator
Recruiting

West-Vlaanderen

A.Z. Sint-Jan Brugge, Bruges, West-Vlaanderen, 8000, Belgium
Fabienne Beyaert, Contact, [email protected]
Recruiting
Universitair Ziekenhuis Antwerpen, Antwerp, 2650, Belgium
Beeldens Jente, Contact, +3 436 8409, [email protected]
Rie Braspenning, Contact, +32 3 821 4002, [email protected]
Christophe De Block, MD, PhD, Principal Investigator
Marieke den Brinker, MD, PhD, Principal Investigator
Niels Bochanen, MD, Sub-Investigator
Recruiting
Universitair Ziekenhuis Gent, Ghent, 9000, Belgium
Nancy Platteau, Contact, +329 332 6394, [email protected]
Els Feyen, Contact, [email protected]
Bruno Lapauw, MD, PhD, Principal Investigator
Joke Marlier, MD, Sub-Investigator
Sara Van Aken, MD, Sub-Investigator
Hasan Kahya, MD, PhD, Sub-Investigator
Recruiting
Universitair Ziekenhuis Brussel, Jette, 1090, Belgium
Karen Hanssens, Contact, +322 477 77 60, [email protected]
Aster Desouter, MD, Principal Investigator
Willem Staels, MD PhD, Sub-Investigator
Recruiting
Universitair Ziekenhuis Leuven, Leuven, 3000, Belgium
Natalie Van den Driessche, Contact, +3216 34 85 54, [email protected]
Pieter Gillard, MD, PhD, Principal Investigator
Kristina Casteels, MD, PhD, Sub-Investigator
Recruiting