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

  • Type 1 Diabetes Mellitus
Trial Status:

Completed

This trial runs in
Countries
  • Austria
  • Germany
  • Poland
  • United Kingdom
Trial Identifier:

NCT03478969 RD002718

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT03478969 , RD002718 Trial Identifier
      Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, Multiple Daily Injections (MDI) therapy Treatments
      Diabetes Mellitus, Type 1 Condition
      Official 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

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 65 Years Age
      No Healthy Volunteers
      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)

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