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

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