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

August 19, 2021 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6800
        • VIVIT Institut am LKH Felkirch
      • Graz, Austria, 8036
        • LKH Graz, Medizinische Universität Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universitat 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 26 weeks
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
Time Frame: 26 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5
Time Frame: Week 26 up to Week 39
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
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
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)
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
Change in Weight from Baseline to Week 39
Baseline up to Week 39
Change in Glycemic Index
Time Frame: Baseline up to Week 39
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)
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
Baseline up to Week 39
Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
Time Frame: Baseline up to Week 39
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)
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
Baseline up to Week 39
Average Time Spent on Infusion Assembly
Time Frame: Baseline up to Week 39
Baseline up to Week 39
Number of Participants With Skin Reactions (Including Type and Intensity)
Time Frame: Baseline up to Week 39
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
Time Frame: Baseline up to Week 39
Baseline up to Week 39
Amount of Waste, Inferred by Total Material Consumption
Time Frame: Baseline up to Week 39
Baseline up to Week 39

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Iris Vesper, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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