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COMPLETED
NCT07711275
NA

Hypoglycemia Thresholds in Type 1 Diabetes

Sponsor: Marmara University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

7 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-12-01

Completion Date

2025-02-25

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

PROCEDURE

threshold 70 mg/dL

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.

PROCEDURE

threshold 65 mg/dL

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.

Locations (1)

Marmara University

Istanbul, Turkey (Türkiye)