Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Backgrounds/Aims: It was the aim to prospectively study the optimum regime of preventive carbohydrate administration for prevention of hypoglycaemic episodes during a standardized bout of physical activity.

Detailed Description
-----------------
Research design and methods: 24 patients with type 1 diabetes participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m., either administering 2 x 10 g or 2 x 20 g carbohydrates (muesli bars) before starting and at 30 min (during the hike). Plasma glucose was determined with a laboratory method and additional carbohydrates needed to treat hypoglycaemia between 2 and 8 p.m. were recorded.

Official Title
-----------------
A Prospective, Randomized Trial Testing Different Regimens of Carbohydrate Administration to Prevent Hypoglycaemia During a Standardized Bout of Moderate Physical Activity in Patients With Type 1 Diabetes

Conditions
-----------------
Hypoglycaemia

Intervention / Treatment
-----------------
* Other: low amount of carbohydrates
* Other: high amount of carbohydrates
* Other: Rapid-acting carbohydrates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration > 1 year Exclusion Criteria: General bad health status, Malignant diseases, Systemic glucocorticoid treatment, Coronary heart disease, Uncontrolled arterial hypertension, Acute infection diseases, Diseases of liver or kidney with significant organ malfunction, Abuse of alcohol or other drugs, Participation in another trial in the last 3 months -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low amount of carbohydrates<br>2 x 10 g carbohydrates (muesli bars) | Other: low amount of carbohydrates<br>* different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes<br>|
| Active Comparator: high amount of carbohydrates<br>2 x 20 g carbohydrates (muesli bars) | Other: high amount of carbohydrates<br>* different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes<br>|
| Other: Rapid-acting carbohydrates<br>30 g rapidly absorbable carboh. + 20 g muesli bar | Other: Rapid-acting carbohydrates<br>* different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbohydrate, hypoglycemia