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

Michael A. Nauck

Status: Completed

Conditions: Hypoglycaemia

Treatments: Other: Rapid-acting carbohydrates; Other: low amount of carbohydrates; Other: high amount of carbohydrates

Study type: Interventional

Funder types: Other

Identifiers

NCT02057848

2014-000561-46 (EudraCT Number)

DZBL-2014-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

low amount of carbohydrates

Active Comparator group

Description:

2 x 10 g carbohydrates (muesli bars)

Treatment:

Other: low amount of carbohydrates

high amount of carbohydrates

Active Comparator group

Description:

2 x 20 g carbohydrates (muesli bars)

Treatment:

Other: high amount of carbohydrates

Rapid-acting carbohydrates

Other group

Description:

30 g rapidly absorbable carboh. + 20 g muesli bar

Treatment:

Other: Rapid-acting carbohydrates