Assessment of Hybrid Use of an Artificial Pancreas in a Home setting for Two Months in Patients with Type 1 Diabetes - DiAs Hybrid Home Trial
Completed
- Conditions
- diabetes10018424
- Registration Number
- NL-OMON41525
- 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
Aged between 18 and 70 years
Diagnosed with type 1 diabetes mellitus
Use of an insulin pump for at least 3 months
HbA1c between 7.5% and 10%
Exclusion Criteria
Diabetic Ketoacidosis within the last 6 months
Pregnancy or breastfeeding
History of cardiovascular event during the prior year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: time in range, Hybrid-AP versus OPEN.<br /><br>The main purpose of this study is to assess the effectiveness of glucose<br /><br>control achieved during 2 months Hybrid-AP during the evening and night-time/<br /><br>open-loop during day-time (Hybrid-AP) versus patient-managed open loop control<br /><br>(OPEN) in a home environment in patients with type 1 diabetes.<br /><br><br /><br>| Extension 1&2: Artificial Pancrease versus OPEN</p><br>
- Secondary Outcome Measures
Name Time Method <p>This study aims at:<br /><br>- Demonstrating the feasibility of prolonged hybrid use of an Artificial<br /><br>Pancreas model at home<br /><br>- Evaluating the effect of using an Artificial Pancreas in hybrid mode on<br /><br>patient quality of life<br /><br><br /><br>| Extension 1&2: Same outcome measures apply</p><br>