NCT07711275Completed
Hypoglycemia Thresholds in Type 1 Diabetes
Impact of Two Different Hypoglycemia Thresholds on Rebound Hyperglycemia in Children With Type 1 Diabetes: A Crossover Clinical Trial
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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 (\<180 mg/dL) at the 2nd hour post-treatment? Patients underwent two protocols: intervention at a 65 mg/dl threshold (hospital routine; experimental group) and 70 mg/dl (literature standard; control group). Both protocols utilised 0.3 g/kg of simple carbohydrates, supplemented with a standardised complex carbohydrate (12.8 g) once blood glucose exceeded the target.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 14 Jul 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 25 Feb 2025
- Lead sponsor
- Marmara University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07711275
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 1 Dec 2024 to the primary completion date, 25 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marmara University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.