RecruitingNot ApplicableNCT05777330

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

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

75 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Type1 Diabetes Mellitus

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. 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) individuals 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 individuals 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 individuals?

Eligibility

Min Age: 5 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is using continuous glucose monitors (CGMs) — small wearable sensors that track blood sugar levels throughout the day and night — to detect early blood sugar abnormalities in children and young adults who carry autoantibodies against the pancreas. These autoantibodies indicate a high risk of eventually developing type 1 diabetes, even before any symptoms appear. **You may be eligible if...** - You are between 5 and 39 years old - You do not yet have a diabetes diagnosis - You have been found to carry one or more autoantibodies associated with type 1 diabetes (IAA, GADA, IA-2A, or ZnT8A) **You may NOT be eligible if...** - You are pregnant, breastfeeding, or less than 6 months postpartum - You already have a diabetes diagnosis - You have a history of substance abuse or significant emotional problems - You are legally incapacitated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOral 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_TESTHyperglycemic 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_TESTContinuous 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.