Feasibility study of an ambulatory closed-loop system for the automated control of blood glucose with remote monitoring in type 1 diabetes (The Diabetes Assistant) - DiAs Trial
Completed
- Conditions
- diabetes10018424
- Registration Number
- NL-OMON39284
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
aged 21 years or older
Diagnosed with type 1 diabetes mellitus
use of an insulin pump for at least 1 year
HbA1c between 6.0% and 9.0%
Exclusion Criteria
Diabetic Ketoacidosis within the last 6 months
Severe hypoglycaemia within the last 12 months
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint will be the percent time the system is operative with all<br /><br>expected data from CGM, pump and patient manual inputs available on the<br /><br>Artificial Pancreas platform and monitoring stations. To be considered as<br /><br>successful, this percent time will have to reach more than 80% of total time of<br /><br>investigation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include the failure rates of system components, frequency<br /><br>of lost or inaccurate CGM records, and percent time of active CTR. The<br /><br>failure/missing data records will be compared to failure/missing data records<br /><br>from our past in-clinic studies.</p><br>