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

November 3, 2023 updated by: Universitair Ziekenhuis Brussel

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 first-degree relatives (age 5-39 years) of type 1 diabetes patients, in comparison with single autoantibody-positive relatives 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. 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. Can (changes in) CGM-derived glycemic variability indices predict/detect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) relatives with the same diagnostic efficiency as OGTT- or clamp-derived variables?
  3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive relatives with the same diagnostic efficiency as OGTT- or clamp-derived variables?
  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 relatives?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2650
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Principal Investigator:
          • Christophe De Block, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marieke den Brinker, MD, PhD
      • Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Lapauw, MD, PhD
        • Sub-Investigator:
          • Joke Marlier, MD
        • Sub-Investigator:
          • Sara Van Aken, MD
      • Jette, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
        • Principal Investigator:
          • Aster Desouter, MD
        • Sub-Investigator:
          • Willem Staels, MD PhD
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven
        • Contact:
        • Principal Investigator:
          • Pieter Gillard, MD, PhD
        • Sub-Investigator:
          • Kristina Casteels, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged 5-39 years at inclusion;
  2. being a sibling, offspring or parent of a patient with confirmed auto-immune type 1 diabetes;
  3. absence of diabetes according to American Diabetes Association (ADA) criteria;
  4. 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 according to 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Autoantibody-positive first-degree relatives of type 1 diabetes patients
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 first-degree relatives 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.

Other Names:
  • OGTT
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 first-degree relatives 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.

Other Names:
  • clamp
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 first-degree relatives 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.

Other Names:
  • CGM
  • Dexcom G6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to persistent dysglycemia
Time Frame: 2-3 years
In initially normoglycemic (single or multiple) autoantibody-positive relatives
2-3 years
Progression to persistent dysglycemia and stage 3 type 1 diabetes
Time Frame: 2-3 years
In all multiple autoantibody-positive relatives
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Juvenile Diabetes Research Foundation
Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Bart Keymeulen, Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PredicT1D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We opt to restrict data access as the project involves personal and sensitive data.

A specific data use agreement could be considered for data sharing after the end of the project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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