Comparison of insulin absorption after administration of insulin lispro with a patch-pump versus a catheter based pump and the effect of catheter wear-time
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON36179
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
Aged 18 years or above
Diagnosed with Type 1 DM at least 6 months according to the WHO definition
Treated with CSII or MDII for at least 3 months
Body Mass Index (BMI) <35 kg/m²
HbA1c measured during the last three months between 6 and 10%
Using <66 insulin units per day on average.
Exclusion Criteria
Patient is pregnant or breastfeeding
Patient is using a medication which significantly impacts glucose metabolism, except if stable for at least 3 months
Patient has a severe medical or psychological condition which, in the opinion of the investigator, prohibits participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be time to peak serum insulin levels following<br /><br>administration of the mealtime insulin bolus with CP and PP, and coefficient of<br /><br>variation (CV) of basal and postprandial insulin levels after CP and PP. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will include postprandial glucose excursions, early insulin<br /><br>t50% and area under the curve for insulin levels, Maximum concentration of<br /><br>insulin levels, delta baseline to peak in insulin levels and coefficient of<br /><br>variation of basal insulin levels. Of the secondary endpoints listed above the<br /><br>same will be determined for glucose levels after administration of mealtime<br /><br>bolus.</p><br>