Monocentric randomised prospective intraindividuel parallel group comparison study to calculate HbA1c of self monitored blood glucose values of the last days and to use blood glucose documentation in a specialized diary with biofeedback system.
Not Applicable
Recruiting
- Conditions
- E10.90E11.90
- Registration Number
- DRKS00004339
- Lead Sponsor
- Praxis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
•Insulin treated patients with diabetes, who have to measure blood glucose at least four times daily (intensified conventionel therapy).
•Insulin treatment at least 6 months.
•age over 18 years
•signed and dated consent
Exclusion Criteria
•reported ketoacidosis in the last 3 months
•reported severe hypoglycemic episode in the last 3 months
•Pregnancy
•patients, who seem unable to follow protokol
•hemoglobin < 11g/dl
•6% < HbA1c > 11%
•patients, who can not legaly sign consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method with hemocue (point of care test) measured HbA1c after 3 and 6 months
- Secondary Outcome Measures
Name Time Method from glucose monitoring system analysed Hypoglycemia, blood glucose variability, calculated HbA1c