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

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Roche

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03478969
RD002718

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

18 to 65 years old

Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

181 participants in 3 patient groups

Group A: Accu-Chek® Solo
Experimental group
Description:
Continuous subcutaneous insulin infusion (CSII) with Accu-Chek® Solo Micropump system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
Treatment:
Device: Accu-Chek® Solo micropump system
Group B: MDI, then Accu-Chek® Solo
Experimental group
Description:
Multiple daily injections (MDI) for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
Treatment:
Device: Accu-Chek® Solo micropump system
Other: Multiple Daily Injections (MDI) therapy
Group C: mylife™ OmniPod®, then Accu-Chek® Solo
Experimental group
Description:
Continuous subcutaneous insulin infusion (CSII) with the mylife™ OmniPod® Insulin Management system for 26 weeks. From Week 26 until Week 39, all Groups will be using the Accu-Chek® Solo Micropump system for CSII therapy.
Treatment:
Device: Accu-Chek® Solo micropump system
Device: mylife™ OmniPod® Insulin Management System

Trial documents
2

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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