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Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System

NCT03478969

CompletedNA

Sponsor: Hoffmann-La Roche

Conditions: Diabetes Mellitus, Type 1

Interventions: Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, Multiple Daily Injections (MDI) therapy

Countries: Austria, Germany, Poland, United Kingdom

This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosed type 1 diabetes mellitus
* At least 6 months experience with MDI therapy
* Age ≥18 years and age ≤ 65
* Able to perform carbohydrate counting
* Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently
* HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months)
* Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures
* Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase
* Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study

Exclusion Criteria:

* Prior insulin pump use
* Relevantly impaired hypoglycemia awareness
* History of \>1 hospitalization due to severe hypoglycemia within the previous 3 months
* History of \>1 hospitalization due diabetic ketoacidosis within the last 3 months
* Significant manifestation of diabetes-related late complications
* Pregnant or planning to become pregnant or breastfeeding
* Known allergic reactions to plaster adhesive
* Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy
* Serious or unstable chronic medical or psychological condition(s)
* Addiction to alcohol or other substance(s) of abuse as determined by the investigator
* Psychological condition rendering the participant unable to understand the nature and the scope of the study
* Plans for relocation or extensive travel
* Participation in another clinical study within 4 weeks prior to the screening visit
* Dependency on Sponsor or Investigator (e.g. co-worker or family member)
Locations (21)
  • Feldkirch, Austria
  • Graz, Austria
  • Innsbruck, Austria
  • Salzburg, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Bad Mergentheim, Germany
  • Essen, Germany
  • Fulda, Germany
  • Lage, Germany
  • Quakenbrück, Germany
  • Rostock, Germany
  • Gdansk, Poland
  • Krakow, Poland
  • Warsaw, Poland
  • Bournemouth, United Kingdom
  • Cambridge, United Kingdom
  • Darlington, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom