Comparison of two artificial pancreas systems for closed-loop blood glucose control versus open loop control in patients with Type 1 diabetes
- Conditions
- diabetes10018424
- Registration Number
- NL-OMON34528
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
aged 18 years or above
diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
Body Mass Index (BMI) <35 kg/m²
treated by basal-bolus insulin therapy using an external insulin pump for at least 3 months
willing to use insulin aspart and wear a continuous glucose monitoring (CGM) device for the duration of the three study days and undergo all study procedures
Exclusion Criteria
Patient is pregnant, or breast feeding during the period of the study
Symptomatic coronary artery disease
Patient is using a medication that significantly impacts glucose metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time spent in target range; this is defined as plasma glucose values between<br /><br>3.9 and 8.0 mmol/L in the basal or late postprandial state (more than 3 hours<br /><br>after breakfast, lunch and dinner) and plasma glucose values between 3.9 and<br /><br>10.0 mmol/L in the early postprandial state (first 3 hours after breakfast,<br /><br>lunch and dinner). </p><br>
- Secondary Outcome Measures
Name Time Method