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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Apr 2026 → Nov 30, 2027
See other at-risk trials from Universitair Ziekenhuis Brussel

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 2026 to Nov 30, 2027
    • Study completion moved earlier from Aug 2028 to Nov 30, 2027
    • Site contacts updated at 1 of 6 sites
    • Study description shortened, about 1 word
    v8
  2. Site contacts updated at 1 of 6 sitesv7
  3. Study description revisedv6
  4. Study sites: 5 to 6v5 Show 4 more changesShow less
    • Study completion date: Apr 2027 to Aug 2028
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 589 words
    • Collaborators: 2 to 1
  5. Study sites: 4 to 5v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 1, 2023 to Aug 9, 2023
    v3
  2. Start date: Apr 2023 to Jun 1, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05777330
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: Breakthrough T1D
Conditions
(from sponsor)		 Type1 Diabetes Mellitus
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov