Clinical trial NCT03478969: Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
timeFrame: 26 weeks
measure: Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
timeFrame: 26 weeks
Secondary outcomes:
measure: Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5
timeFrame: Week 26 up to Week 39
measure: Device Satisfaction and Treatment Preference
timeFrame: Baseline up to Week 39
measure: Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels
timeFrame: Baseline up to Week 39
measure: Therapy Success Indicated by Change in Body Mass Index (BMI)
timeFrame: Baseline up to Week 39
measure: Therapy Success Indicated by Change in Weight
timeFrame: Baseline up to Week 39
measure: Change in Glycemic Index
timeFrame: Baseline up to Week 39
measure: Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)
timeFrame: Baseline up to Week 39
measure: Change in Therapy Parameters Based on Type of Insulin Used
timeFrame: Baseline up to Week 39
measure: Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)
timeFrame: Baseline up to Week 39
measure: Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)
timeFrame: Baseline up to Week 39
measure: Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day
timeFrame: Baseline up to Week 39
measure: Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges
timeFrame: Baseline up to Week 39
measure: Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges
timeFrame: Baseline up to Week 39
measure: Number of Consultations
timeFrame: Baseline up to Week 39
measure: Number of Pods/Infusion Assemblies Falling Off Prematurely
timeFrame: Baseline up to Week 39
measure: Average Time Spent on Infusion Assembly
timeFrame: Baseline up to Week 39
measure: Number of Participants With Skin Reactions (Including Type and Intensity)
timeFrame: Baseline up to Week 39
measure: Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard
timeFrame: Baseline up to Week 39
measure: Amount of Waste, Inferred by Total Material Consumption
timeFrame: Baseline up to Week 39
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: VIVIT Institut am LKH Felkirch
city: Graz
country: Austria
facility: LKH Graz, Medizinische Universität Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)
city: Salzburg
country: Austria
facility: Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel
city: Vienna
country: Austria
facility: Hietzing Hospital
city: Bad Mergentheim
country: Germany
facility: Diabetes Klinik Bad Mergentheim GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Fulda
country: Germany
facility: Gemeinschaftspraxis im Altstadt-Carree
city: Lage
country: Germany
facility: Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms
city: Quakenbrueck
country: Germany
facility: Diabeteszentrum am CKQ
city: Rostock
country: Germany
facility: Diabendo Praxiszentrum
city: Gdansk
country: Poland
facility: Regionalne Centrum Diabetologii - Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Jagiellonian University
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the MSWiA in Warsaw
city: Bournemouth
country: United Kingdom
facility: Bournemouth Diabetes and Endocrine Centre
city: Cambridge
country: United Kingdom
facility: Wolfson Diabetes & Endocrine Clinic
city: Darlington
country: United Kingdom
facility: Centre for Clinical Research and Innovation
city: London
country: United Kingdom
facility: King's College London, Diabetes Research Group
city: London
country: United Kingdom
facility: Imperial College London, Diabetes, Endocrinology and Metabolism Division
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Iris Vesper
role: STUDY_DIRECTOR
References: