Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 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; |
|
| Experiment group | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University | Istanbul | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |