Patient satisfaction with a new smart and cost-effective Insulin Patch Pump System in type 1 diabetes patients using CSII and CGM or Flash glucose monitoring system
Completed
- Conditions
- type 1 diabetes10018424
- Registration Number
- NL-OMON55242
- Lead Sponsor
- Van Heek Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
* Male and female patients
* T1D patients <=>18 years
* Using CSII for 12 months or longer and needing a new pump within 6 months
* Using CGM or FGM
* Written informed consent obtained from the patient
Exclusion Criteria
* Pregnancy or pregnancy wish
* Patients unable to understand spoken and written Dutch language
* Patients on (hybrid) closed loop systems, i.e. Medtronic 670G pump
* Patients on Medtronic 640G CSII pump that also use CGM-based *stop before low*
* Patients with unstable glucose regulation, for example frequent hypo- or
hyperglycaemia
* Not able to perform the study according to the treating physician
* Severe comorbidity and/or psychiatric disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patient satisfaction compared to current CSII system</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of perceived dysfunctions, unexpected hypo- and hyperglycaemia,<br /><br>ketoacidosis</p><br>