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Completed
NCT07711275
Hypoglycemia Thresholds in Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1
Sex: All
Ages: 7 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 33
Sponsor: Marmara University
Location: Marmara University Istanbul
Summary
The aim of this study is to compare the impact of hypoglycaemia treatment initiated at a blood glucose threshold of 65 mg/dL versus the internationally recommended threshold of 70 mg/dL on 2-hour post-treatment blood glucose levels and the subsequent development of rebound hyperglycaemia in children with type 1 diabetes. The main questions it aims to answer are:
Is there a statistically significant difference in 2-hour post-treatment blood glucose levels in children with type 1 diabetes when hypoglycaemia intervention is initiated at a threshold of 70 mg/dL compared to 65 mg/dL?"
In children with type 1 diabetes, does the standard hypoglycaemia treatment initiated at the internationally recommended threshold of 70 mg/dL lead to the development of rebound hyperglycaemia (\
Eligibility Criteria
Inclusion Criteria:
* A confirmed diagnosis of type 1 diabetes.
* Absence of any concurrent chronic illnesses.
* Absence of any physiological conditions precluding oral intake.
* Absence of significant cognitive or developmental disorders that would impede capacity to participate in the study.
* Aged between 7 and 18 years (as children under 7 years of age may experience difficulty consuming whole grain crackers).
* Possession of a personal blood glucose monitor.
* Absence of persistent hyperglycaemia.
Exclusion Criteria:
* Days characterised by unusually high levels of routine exercise or physical activity.
* The requirement for a second dose of simple carbohydrates (sugar cubes) during a single hypoglycaemia intervention (as consuming two doses may induce hyperglycaemia following the snack).
* Experiencing multiple hypoglycaemic episodes within the same day.
Source: ClinicalTrials.gov (NCT07711275). StuddyBuddy aggregates publicly available trial information.