Carbohydrates to Prevent Hypoglycaemia During Physical Activity in Patients With Type 1 Diabetes
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
2 other identifiers
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedFebruary 7, 2014
February 1, 2014
2.6 years
February 5, 2014
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma glucose
6 hours
Study Arms (3)
low amount of carbohydrates
ACTIVE COMPARATOR2 x 10 g carbohydrates (muesli bars)
high amount of carbohydrates
ACTIVE COMPARATOR2 x 20 g carbohydrates (muesli bars)
Rapid-acting carbohydrates
OTHER30 g rapidly absorbable carboh. + 20 g muesli bar
Interventions
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus, 18-75 years, BMI 18-35 kg/m², Diabetes duration \> 1 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael A. Naucklead
Study Sites (1)
Diabeteszentrum
Bad Lauterberg im Harz, 37431, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Nauck, Prof. Dr.
Diabeteszentrum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 7, 2014
Study Start
July 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 7, 2014
Record last verified: 2014-02