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

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how changes in blood sugar levels can help predict when people might develop problems related to diabetes, specifically in those who are related to someone with type 1 diabetes. The researchers will use a device called continuous glucose monitoring (CGM) to keep track of sugar levels in the body over time in participants who are between the ages of 5 and 39. The study includes both relatives who have one type of diabetes-related antibody and those who have multiple antibodies. Participants will undergo tests every few months to measure their blood sugar response after eating and to monitor their overall health for at least 2-3 years.

To be eligible for the trial, you must be between the ages of 5 and 39, related to someone with type 1 diabetes, and not have diabetes yourself. The study will not accept individuals who are pregnant, have a history of certain medical conditions, or are taking specific medications that could affect the results. If you join the study, you'll be part of an important effort to understand how blood sugar levels change over time and how these changes can signal the onset of diabetes. Your participation could help improve diabetes care for future generations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. aged 5-39 years at inclusion;
• • 2. absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria;
• • 3. 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 meeting the clinical diagnostic 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.