Evaluation of the Usability and Pharmaeconomy of the MicroTech Insulin Pump System
Phase 4
Recruiting
- Conditions
- Diabetes type 1 and 2
- Registration Number
- DRKS00033431
- Lead Sponsor
- MicroTech Medical (Hangzhou) Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Patients on insulin pump treatment (CSII, 100 patients)
Patients on insulin treatment (20 patients, Germany only)
HbA1c < 9.0 %
Subjects who are able to complete informed consent form (by him-/herself or by his/her guardian)
Exclusion Criteria
Hypoglycemia unawareness
Pregnancy
Nursing mothers
Any reason for not being able to comply with the protocol.
Serious disease or illness
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment efficacy (HbA1c and hypoglycemia frequency)
- Secondary Outcome Measures
Name Time Method Pharmacoeconomic aspects (treatment costs)<br>Safety aspects (AEs and ADEs) <br>Environmental aspects (waste reduction)