Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 4
Completed
- Conditions
- Diabetes Mellitus type 1 / diabetes10018424
- Registration Number
- NL-OMON40156
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Diagnosed with diabetes mellitus type 1;
Treated with continuous subcutaneous insulin infusion for a minimum of 6 months;
Age between 18 and 75 years.
Exclusion Criteria
Impaired awareness of hypoglycaemia according to Gold and/or Clarke questionnaire ;
BMI > 35 kg/m2;
HbA1c > 11.0%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter is the mean sensor glucose concentration, which will be<br /><br>compared between open and closed loop.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are:<br /><br>-the proportion of time spent and the number of events in the following<br /><br>categories: low glucose, very low glucose, dangerously low glucose, high<br /><br>glucose, very high glucose, and dangerously high glucose;<br /><br>-the number of carbohydrate-treated hypoglycemic events;<br /><br>-the proportion of time spent in euglycemia;<br /><br>-glycemic variability;<br /><br>-day, night, and postprandial mean glucose concentration;<br /><br>-MARD (mean absolute relative difference) of the glucose sensors compared to<br /><br>self-monitored blood glucose;<br /><br>-Heart rate and physical activity;<br /><br>-Mean glucose concentration per day (closed loop only);<br /><br>-Time that the control algorithm is inactive (closed loop only).</p><br>