Hypoglycemia Thresholds in Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

threshold 70 mg/dL

Procedure

At these levels, children with type 1 diabetes were administered 0.3 g/kg of simple carbohydrates in the form of sugar cubes, and blood glucose was re-evaluated 15 minutes later. According to the ISPAD consensus guidelines, once blood glucose rises above 70 mg/dL following the administration of fast-acting carbohydrates, 10-15 g of complex carbohydrates should be given. As the complex carbohydrate source, the children were provided with four crackers (12.8 g) containing quinoa, black cumin, bran, and oats. Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.

threshold 65 mg/dL

Procedure

Primary outcomes

Blood glucose levels were measured at 1 and 2 hours post-treatment

Time frame: 1 and 2 hours post-treatment

Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Impact of Two Different Hypoglycemia Thresholds on Rebound Hyperglycemia in Children With Type 1 Diabetes: A Crossover Clinical Trial

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 17, 2026
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed