PRO Solo Study - RD002718
Research type
Research Study
Full title
Patient-Reported Outcomes with the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. mylife OmniPod® in Patients with Type 1 Diabetes
IRAS ID
242697
Contact name
Nicholas/NO Oliver
Contact email
Sponsor organisation
Roche Diabetes Care GmbH
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-17-10-021850, EUDAMED ID
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
The study will assess treatment satisfaction in patients with type 1 diabetes comparing Accu-Chek® Solo to standard therapy via MDI and to mylife OmniPod after 26 weeks of therapy. This will be done by using a specific patient questionnaire, the Diabetes Technology Questionnaire (DTQ).
The Accu Chek® Solo micropump system is a new generation of tubeless insulin pumps, designed for maintaining tight control of blood glucose concentrations in people with insulin dependent diabetes.
The micropump system is miniaturized, so it can be worn directly on the body. Nevertheless, the electronic and electro-mechanical components can be used for several months. Only the insulin reservoir and the infusion cannula setup are replaced every few days.The study will be performed in diabetic practices and clinical centers, spread over Germany, Austria, United Kingdom and Poland.
The study duration will be approximately 40 weeks and will involve up to 5 study visits. At study start the patients will be randomly allocated (1:1:1 ratio) to one of three treatment groups to
*Group A: CSII therapy with the Accu-Chek® Solo micropump system for 26 weeks;
*Group B: Multiple daily injections (MDI) for 26 weeks; or
*Group C: CSII therapy with the mylifeTM Omnipod® system for 26 weeks.
Follow up: From Week 26 until Week 39, all groups will be using the Accu-Chek® Solo micropump system.During the visits the patients will be asked to complete patient questionnaires. Furthermore information, such as changes in concomitant medications and occurrence of adverse events, potential malfunction of the study device, hypoglycemic event experienced, will be collected from the patients.
Blood will be drawn for analysis of HbA1c and insertion sites and areas of the patients`s body where the pump has been placed will be examined. The data from the study device will be downloaded.There may also be a follow-up phone call within 2-5 days post study.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/1007
Date of REC Opinion
14 Aug 2018
REC opinion
Further Information Favourable Opinion