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Diabetes Mellitus, Type 1PRO SoloNCT03478969

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

A study testing Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System and Multiple Daily Injections (MDI) therapy in people with Diabetes Mellitus, Type 1, run by Hoffmann-La Roche at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System and Multiple Daily Injections (MDI) therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
21 sitesin 4 countries
Study dates
17 May 2018to 18 May 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

Austria6 sites

  • VIVIT Institut am LKH Felkirch

    Feldkirch, 6800

  • LKH Graz, Medizinische Universität Graz

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)

    Salzburg, 5020

  • Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel

    Salzburg, 5026

  • Hietzing Hospital

    Vienna, 1130

Other trials in Austria

Germany6 sites

  • Diabetes Klinik Bad Mergentheim GmbH

    Bad Mergentheim, 97980

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Gemeinschaftspraxis im Altstadt-Carree

    Fulda, 36037

  • Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms

    Lage, 32791

  • Diabeteszentrum am CKQ

    Quakenbrück, 49610

  • Diabendo Praxiszentrum

    Rostock, 18057

Other trials in Germany

United Kingdom6 sites

  • Bournemouth Diabetes and Endocrine Centre

    Bournemouth, BH7 7DW

  • Wolfson Diabetes & Endocrine Clinic

    Cambridge, CB2 0QQ

  • Centre for Clinical Research and Innovation

    Darlington, DL3 6HX

  • King's College London, Diabetes Research Group

    London, SE5 9RS

  • Imperial College London, Diabetes, Endocrinology and Metabolism Division

    London, W12 0NN

  • Manchester Royal Infirmary, University Hospital

    Manchester, M13 9WL

Other trials in United Kingdom

Poland3 sites

  • Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Jagiellonian University

    Krakow, 31-501

  • Central Clinical Hospital of the MSWiA in Warsaw

    Warsaw, 02-507

Other trials in Poland

About this study

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

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.

Being tested
Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, Multiple Daily Injections (MDI) therapy
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accu-Chek® Solo micropump systemDevice

    Medical device for subcutaneous delivery of insulin in a personalized way.

  • mylife™ OmniPod® Insulin Management SystemDevice

    A patch pump system delivering insulin.

  • Multiple Daily Injections (MDI) therapyOther

    Injecting insulin as per participant's need.

Study groups in NCT03478969
Study groupRoleWhat they receive
Group A: Accu-Chek® SoloExperimentalContinuous 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.
Receives: Device: Accu-Chek® Solo micropump system
Group B: MDI, then Accu-Chek® SoloExperimentalMultiple 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.
Receives: Device: Accu-Chek® Solo micropump system; Other: Multiple Daily Injections (MDI) therapy
Group C: mylife™ OmniPod®, then Accu-Chek® SoloExperimentalContinuous 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.
Receives: Device: Accu-Chek® Solo micropump system; Device: mylife™ OmniPod® Insulin Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 26 weeks

  2. 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.

    Measured: 26 weeks

Secondary outcomes (19)

  1. 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.

    Measured: Week 26 up to Week 39

  2. 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.

    Measured: Baseline up to Week 39

  3. Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels

    Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39

    Measured: Baseline up to Week 39

  4. 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.

    Measured: Baseline up to Week 39

  5. Therapy Success Indicated by Change in Weight

    Change in Weight from Baseline to Week 39

    Measured: Baseline up to Week 39

  6. Change in Glycemic Index

    Change in Glycemic Index from Baseline to Week 39

    Measured: Baseline up to Week 39

  7. 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.

    Measured: Baseline up to Week 39

  8. Change in Therapy Parameters Based on Type of Insulin Used

    Measured: Baseline up to Week 39

  9. Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)

    Total Daily Insulin Dose at Baseline compared to dose at Week 39

    Measured: Baseline up to Week 39

  10. 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

    Measured: Baseline up to Week 39

  11. 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

    Measured: Baseline up to Week 39

  12. 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.

    Measured: Baseline up to Week 39

  13. 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.

    Measured: Baseline up to Week 39

  14. Number of Consultations

    Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school.

    Measured: Baseline up to Week 39

  15. Number of Pods/Infusion Assemblies Falling Off Prematurely

    Measured: Baseline up to Week 39

  16. Average Time Spent on Infusion Assembly

    Measured: Baseline up to Week 39

  17. 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".

    Measured: Baseline up to Week 39

  18. Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard

    Measured: Baseline up to Week 39

  19. Amount of Waste, Inferred by Total Material Consumption

    Measured: Baseline up to Week 39

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2018
  2. Study start17 May 2018
  3. Primary completion18 May 2020
  4. Study completion18 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03478969
Sponsor's protocol ID
RD002718
Acronym
PRO Solo
Status last verified
Aug 2021
First submitted
13 Mar 2018
Last updated
20 Aug 2021
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Barnard-Kelly K, Thienel F, Mader JK, Oliver N, Franek E, Vesper I, Dagenbach N, Vogt G, Etter T, Kunsting T. A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections. J Diabetes Sci Technol. 2025 Sep;19(5):1310-1316. doi: 10.1177/19322968241234055. Epub 2024 Mar 8.

    PubMed 38456441

Questions about this trial

What is this clinical trial studying?

A study testing Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System and Multiple Daily Injections (MDI) therapy in people with Diabetes Mellitus, Type 1, run by Hoffmann-La Roche at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Austria, Germany, United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03478969, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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