Fully Automated glycemic control with ultrarapid insulin in a bihormonal closed loop System in patients with Type 1 diabetes.
Completed
- Conditions
- Type 1 diabetes10018424
- Registration Number
- NL-OMON51782
- Lead Sponsor
- Inreda Diabetic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
- Diagnosed with type 1 diabetes
- Treated with the Inreda Artificial Pancreas for a minimum of 1 month
- Age between 18 and 75 years
- Willing and able to sign informed consent
Exclusion Criteria
- Impaired awareness of hypoglycemia (score >= 4) according to the Gold and/or
Clarke questionnaire
- Pregnancy and/or breastfeeding
- Use of oral antidiabetic agents
- Insulinoma
- Hypersensitivity reactions to Lyumjev insulin or any of the excipients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main parameter to express efficacy is the time above range (>10 mmol/l), which<br /><br>will be compared between Lyumjev and Humalog. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety parameters<br /><br>- Side effects of Lyumjev<br /><br><br /><br>Pharmacodynamic parameters<br /><br>- Percentage of time spent in range (3.9-10.0 mmol/l)<br /><br>- Percentage of time spent below range (< 3.9 mmol/l)<br /><br>- Percentage of time spent in level 2 below range (< 3.0 mmol/l)<br /><br>- Percentage of time spent in level 2 above range (> 13.9 mmol/l)<br /><br>- Mean/median glucose value<br /><br>- Glycemic variability expressed as coefficient of variation (CV) and<br /><br>interquartile range (IQR)<br /><br><br /><br>AP-related parameters<br /><br>- Daily administered dosage of glucagon<br /><br>- Daily administered dosage of insulin<br /><br>- The percentage of time that the closed loop algorithm is active</p><br>