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

Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Accu-Chek® Solo micropump system; Other: Multiple Daily Injections (MDI) therapy; Device: mylife™ OmniPod® Insulin Management System

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6800
    • VIVIT Institut am LKH Felkirch
  • Graz, Austria, 8036
    • LKH Graz, Medizinische Universität Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
  • Salzburg, Austria, 5026
    • Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
  • Vienna, Austria, 1130
    • Hietzing Hospital
• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetes Klinik Bad Mergentheim GmbH
  • Essen, Germany, 45136
    • InnoDiab Forschung Gmbh
  • Fulda, Germany, 36037
    • Gemeinschaftspraxis im Altstadt-Carree
  • Lage, Germany, 32791
    • Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
  • Quakenbrueck, Germany, 49610
    • Diabeteszentrum am CKQ
  • Rostock, Germany, 18057
    • Diabendo Praxiszentrum
• Poland
  • Gdansk, Poland, 80-952
    • Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-501
    • Jagiellonian University
  • Warsaw, Poland, 02-507
    • Central Clinical Hospital of the MSWiA in Warsaw
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Bournemouth Diabetes and Endocrine Centre
  • Cambridge, United Kingdom, CB2 0QQ
    • Wolfson Diabetes & Endocrine Clinic
  • Darlington, United Kingdom, DL3 6HX
    • Centre for Clinical Research and Innovation
  • London, United Kingdom, SE5 9RS
    • King's College London, Diabetes Research Group
  • London, United Kingdom, W12 0NN
    • Imperial College London, Diabetes, Endocrinology and Metabolism Division
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Accu-Chek® Solo; 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.	Device: Accu-Chek® Solo micropump system; Medical device for subcutaneous delivery of insulin in a personalized way.
Experimental: Group B: MDI, then Accu-Chek® Solo; 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.	Device: Accu-Chek® Solo micropump system; Medical device for subcutaneous delivery of insulin in a personalized way.; Other: Multiple Daily Injections (MDI) therapy; Injecting insulin as per participant's need.
Experimental: Group C: mylife™ OmniPod®, then Accu-Chek® Solo; 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.	Device: Accu-Chek® Solo micropump system; Medical device for subcutaneous delivery of insulin in a personalized way.; Device: mylife™ OmniPod® Insulin Management System; A patch pump system delivering insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score	The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.	26 weeks
Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score	The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5	The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress.	Week 26 up to Week 39
Device Satisfaction and Treatment Preference	Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device.	Baseline up to Week 39
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels	Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39	Baseline up to Week 39
Therapy Success Indicated by Change in Body Mass Index (BMI)	This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m^2. Change in BMI from Baseline to Week 39.	Baseline up to Week 39
Therapy Success Indicated by Change in Weight	Change in Weight from Baseline to Week 39	Baseline up to Week 39
Change in Glycemic Index	Change in Glycemic Index from Baseline to Week 39	Baseline up to Week 39
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)	Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy.	Baseline up to Week 39
Change in Therapy Parameters Based on Type of Insulin Used		Baseline up to Week 39
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)	Total Daily Insulin Dose at Baseline compared to dose at Week 39	Baseline up to Week 39
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)	Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39	Baseline up to Week 39
Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day	Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39	Baseline up to Week 39
Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges	Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges.	Baseline up to Week 39
Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges	Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges.	Baseline up to Week 39
Number of Consultations	Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.	Baseline up to Week 39
Number of Pods/Infusion Assemblies Falling Off Prematurely		Baseline up to Week 39
Average Time Spent on Infusion Assembly		Baseline up to Week 39
Number of Participants With Skin Reactions (Including Type and Intensity)	Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely "itching", "redness", "swelling", "heat" and "pain". Each of these questions could be answered with one of four alternatives, "None", "Minor", "Moderate" and "Severe".	Baseline up to Week 39
Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard		Baseline up to Week 39
Amount of Waste, Inferred by Total Material Consumption		Baseline up to Week 39

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Iris Vesper, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): May 18, 2020
• Study Completion (Actual): May 18, 2020

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: RD002718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No