Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable Closed Loop format in patients after Total Pancreatectomy, APPEL 5+
Completed
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON49195
- 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
Patients who underwent total pancreatectomy;
Age *18 years.
Exclusion Criteria
Impaired awareness of hypoglycemia;
Total pancreatectomy performed within less than 3 months before start of trial;
BMI > 35 kg/m2;
HbA1c > 90 mmol/mol;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the percentage of time spent in the target range<br /><br>(3.9-10 mmol/L) which will be compared between open and closed loop.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are:<br /><br>- The proportion of time spent in hypoglycemia and hyperglycemia;<br /><br>- Median glucose concentration;<br /><br>- Glycemic variability;<br /><br>- Day and night median glucose concentration;<br /><br>- Day and night time spent in hypo-, hyper-, and euglycemia;<br /><br>- Percentage of time that the closed loop algorithm is active;<br /><br>- Mean absolute relative difference for the glucose sensor of the closed loop<br /><br>system.</p><br>