Hypoglycemia Thresholds in Type 1 Diabetes

NCT07711275 | Completed

• 1 other identifier: 19.11.2024/4619
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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 (\<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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia; Blood Glucose; Child

Outcome Measures

Primary Outcomes (1)

• Blood glucose levels were measured at 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.

  1 and 2 hours post-treatment

Study Arms (2)

Control group-threshold 70 mg/dL

ACTIVE COMPARATOR

In the control group, the hypoglycaemia threshold was established in accordance with the ISPAD consensus guidelines. For this condition, the blood glucose threshold for hypoglycaemia intervention was defined as below 70 mg/dL;

Procedure: threshold 70 mg/dL

Experiment group-threshold 65 mg/dL

EXPERIMENTAL

In the experiment group, the routine clinical practice of the hospital was maintained. For this condition, the blood glucose threshold for hypoglycaemia intervention was defined as below 65 mg/dL

Procedure: threshold 65 mg/dL

Interventions

threshold 65 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.

Experiment group-threshold 65 mg/dL

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.

Control group-threshold 70 mg/dL

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: December 1, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

TU (1)