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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Accu-Chek® Solo micropump system
mylife™ OmniPod® Insulin Management System
Multiple Daily Injections (MDI) therapy
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • VIVIT Institut am LKH Felkirch
  • LKH Graz, Medizinische Universität Graz
  • Medizinische Universität Innsbruck
  • Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
  • Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
  • Hietzing Hospital
  • Diabetes Klinik Bad Mergentheim GmbH
  • InnoDiab Forschung GmbH
  • Gemeinschaftspraxis im Altstadt-Carree
  • Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
  • Diabeteszentrum am CKQ
  • Diabendo Praxiszentrum
  • Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
  • Jagiellonian University
  • Central Clinical Hospital of the MSWiA in Warsaw
  • Bournemouth Diabetes and Endocrine Centre
  • Wolfson Diabetes & Endocrine Clinic
  • Centre for Clinical Research and Innovation
  • King's College London, Diabetes Research Group
  • Imperial College London, Diabetes, Endocrinology and Metabolism Division
  • Manchester Royal Infirmary, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A: Accu-Chek® Solo

Group B: MDI, then Accu-Chek® Solo

Group C: mylife™ OmniPod®, then Accu-Chek® Solo

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
Change in Glycated Haemoglobin (HbA1c) Levels from Baseline 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.
Therapy Success Indicated by Change in Weight
Change in Weight from Baseline to Week 39
Change in Glycemic Index
Change in Glycemic Index from Baseline 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.
Change in Therapy Parameters Based on Type of Insulin Used
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Total Daily Insulin Dose at Baseline compared to dose at 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
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
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.
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.
Number of Consultations
Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.
Number of Pods/Infusion Assemblies Falling Off Prematurely
Average Time Spent on Infusion Assembly
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".
Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard
Amount of Waste, Inferred by Total Material Consumption

Full Information

First Posted
March 13, 2018
Last Updated
August 19, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03478969
Brief Title
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Acronym
PRO Solo
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Accu-Chek® Solo
Arm Type
Experimental
Arm 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.
Arm Title
Group B: MDI, then Accu-Chek® Solo
Arm Type
Experimental
Arm 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.
Arm Title
Group C: mylife™ OmniPod®, then Accu-Chek® Solo
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Accu-Chek® Solo micropump system
Intervention Description
Medical device for subcutaneous delivery of insulin in a personalized way.
Intervention Type
Device
Intervention Name(s)
mylife™ OmniPod® Insulin Management System
Intervention Description
A patch pump system delivering insulin.
Intervention Type
Other
Intervention Name(s)
Multiple Daily Injections (MDI) therapy
Intervention Description
Injecting insulin as per participant's need.
Primary Outcome Measure Information:
Title
Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
Description
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.
Time Frame
26 weeks
Title
Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5
Description
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.
Time Frame
Week 26 up to Week 39
Title
Device Satisfaction and Treatment Preference
Description
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.
Time Frame
Baseline up to Week 39
Title
Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
Description
Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39
Time Frame
Baseline up to Week 39
Title
Therapy Success Indicated by Change in Body Mass Index (BMI)
Description
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.
Time Frame
Baseline up to Week 39
Title
Therapy Success Indicated by Change in Weight
Description
Change in Weight from Baseline to Week 39
Time Frame
Baseline up to Week 39
Title
Change in Glycemic Index
Description
Change in Glycemic Index from Baseline to Week 39
Time Frame
Baseline up to Week 39
Title
Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
Description
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.
Time Frame
Baseline up to Week 39
Title
Change in Therapy Parameters Based on Type of Insulin Used
Time Frame
Baseline up to Week 39
Title
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Description
Total Daily Insulin Dose at Baseline compared to dose at Week 39
Time Frame
Baseline up to Week 39
Title
Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
Description
Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39
Time Frame
Baseline up to Week 39
Title
Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day
Description
Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39
Time Frame
Baseline up to Week 39
Title
Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges
Description
Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges.
Time Frame
Baseline up to Week 39
Title
Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges
Description
Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges.
Time Frame
Baseline up to Week 39
Title
Number of Consultations
Description
Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.
Time Frame
Baseline up to Week 39
Title
Number of Pods/Infusion Assemblies Falling Off Prematurely
Time Frame
Baseline up to Week 39
Title
Average Time Spent on Infusion Assembly
Time Frame
Baseline up to Week 39
Title
Number of Participants With Skin Reactions (Including Type and Intensity)
Description
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".
Time Frame
Baseline up to Week 39
Title
Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard
Time Frame
Baseline up to Week 39
Title
Amount of Waste, Inferred by Total Material Consumption
Time Frame
Baseline up to Week 39

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Vesper
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
VIVIT Institut am LKH Felkirch
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
LKH Graz, Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
City
Salzburg
ZIP/Postal Code
5026
Country
Austria
Facility Name
Hietzing Hospital
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Diabetes Klinik Bad Mergentheim GmbH
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
InnoDiab Forschung GmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Gemeinschaftspraxis im Altstadt-Carree
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
City
Lage
ZIP/Postal Code
32791
Country
Germany
Facility Name
Diabeteszentrum am CKQ
City
Quakenbrueck
ZIP/Postal Code
49610
Country
Germany
Facility Name
Diabendo Praxiszentrum
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Jagiellonian University
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Central Clinical Hospital of the MSWiA in Warsaw
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Bournemouth Diabetes and Endocrine Centre
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Wolfson Diabetes & Endocrine Clinic
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Centre for Clinical Research and Innovation
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
King's College London, Diabetes Research Group
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College London, Diabetes, Endocrinology and Metabolism Division
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Manchester Royal Infirmary, University Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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