Clinical trial for Type1 Diabetes Mellitus
Official title Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
ClinicalTrials.gov ID: NCT05777330
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 39
You may be able to join if
- aged 5-39 years at inclusion;
- 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 likely can't join 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...
- Gastric bypass or banding;
See the full eligibility criteria
- aged 5-39 years at inclusion;
- 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.
- 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 people.
The study team makes the final eligibility decision.
Where it's taking place
- Liège, Liège, Belgium
- Bruges, West-Vlaanderen, Belgium
- Antwerp, Belgium
- Ghent, Belgium
- Jette, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liège, Liège, Belgium; Bruges, West-Vlaanderen, Belgium; Antwerp, Belgium; Ghent, Belgium; Jette, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.