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

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

August 9, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

August 31, 2028

Conditions
Type1 Diabetes Mellitus
Interventions
DIAGNOSTIC_TEST

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."

DIAGNOSTIC_TEST

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 in participants aged between 5-11 years."

DIAGNOSTIC_TEST

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."

Trial Locations (6)

1090

RECRUITING

Universitair Ziekenhuis Brussel, Jette

2650

RECRUITING

Universitair Ziekenhuis Antwerpen, Antwerp

3000

RECRUITING

Universitair Ziekenhuis Leuven, Leuven

4000

RECRUITING

Clinique CHC MontLégia, Liège

8000

RECRUITING

A.Z. Sint-Jan Brugge, Bruges

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Breakthrough T1D

OTHER

lead

Universitair Ziekenhuis Brussel

OTHER

NCT05777330 - Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes | Biotech Hunter | Biotech Hunter