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

Hoffmann-La Roche181 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

181

Conditions

Diabetes Mellitus, Type 1

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (21)

VIVIT Institut am LKH Felkirch

Feldkirch, Austria

Outcomes

Primary Outcomes

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.

Time frame: 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

Secondary Outcomes

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.

Time frame: Week 26 up to Week 39

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

LKH Graz, Medizinische Universität Graz

Medizinische Universität Innsbruck

Innsbruck, Austria

Salzburger Landeskliniken - Universitätsklinikum Salzburg (SALK)

Salzburg, Austria

Diakonissen & Wehrle Privatklinik GmbH, Standort Andräviertel

Salzburg, Austria

Hietzing Hospital

Vienna, Austria

Diabetes Klinik Bad Mergentheim GmbH

Bad Mergentheim, Germany

InnoDiab Forschung GmbH

Essen, Germany

Gemeinschaftspraxis im Altstadt-Carree

Fulda, Germany

Gemeinschaftspraxis Drs Bieber Kraus Nolte Vortherms

Lage, Germany

...and 11 more locations

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.