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

NCT05777330 | Recruiting

• 1 other identifier: PredicT1D
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

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. 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. 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. 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. 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?

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Autoantibody-positive individuals

OTHER

Diagnostic Test: Oral glucose tolerance test (OGTT); Diagnostic Test: Hyperglycemic clamp test; Diagnostic Test: Continuous glucose monitoring

Interventions

Oral glucose tolerance test (OGTT) DIAGNOSTIC_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. OGTT is performed every 6 months (every 3 months in case of dysglycemia) in all participants.

Also known as: OGTT

Autoantibody-positive individuals

Hyperglycemic clamp test DIAGNOSTIC_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.

Also known as: clamp

Autoantibody-positive individuals

Continuous glucose monitoring DIAGNOSTIC_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. A 10-day CGM recording is performed every 6 months (every 3 months in case of dysglycemia) in all participants.

Also known as: Dexcom G6, CGM

Autoantibody-positive individuals

Eligibility Criteria

• Age: 5 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria;
• persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A.

You may not qualify if:

• Pregnancy or lactation in women; \<6 months postpartum
• Diabetes meeting the clinical diagnostic ADA criteria;
• Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse;
• Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders;
• 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;
• Gastric bypass or banding;
• History of acute or chronic pancreatitis, or (partial) pancreatectomy
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Breakthrough T1D: collaborator

Study Sites (6)

Clinique CHC MontLégia

Liège, Liège, 4000, Belgium

RECRUITING

A.Z. Sint-Jan Brugge

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Glucose Tolerance Test; Glucose Clamp Technique; Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Chemistry Techniques, Analytical; Monitoring, Physiologic

Study Officials

• Bart Keymeulen

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belgian Diabetes Registry

CONTACT

02 477 45 46; contact@bdronline.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: August 9, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)