N/A
Completed N=181
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03478969 ↗
Enrolled (actual)
181
Serious AEs
4.6%
Results posted
Aug 2021
Primary outcomePrimary: Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score — 105.9; 94.8 Scores on a Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score |
105.9; 94.8 | — |
| PRIMARY Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score |
105.1; 108.7 | — |
| SECONDARY Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5 |
7.0; 7.8; 5.3; 6.3; 7.1; 5.8 | — |
| SECONDARY Device Satisfaction and Treatment Preference |
35.3; 33.8; 35.7; 34.9; 34.0; 34.9 | — |
| SECONDARY Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels |
8.0; 8.0; 8.0; 7.8; 8.0; 7.9 | — |
| SECONDARY Therapy Success Indicated by Change in Body Mass Index (BMI) |
25.4; 27.1; 27.0; 25.3; 27.1; 27.0 | — |
| SECONDARY Therapy Success Indicated by Change in Weight |
77.2; 81.7; 83.4; 77.6; 82.3; 83.8 | — |
| SECONDARY Change in Glycemic Index |
77.0; 71.7; 68.1; 75.0; 70.2; 68.9 | — |
| SECONDARY Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII) |
62; 61; 56; 47; 45; 32 | — |
| SECONDARY Change in Therapy Parameters Based on Type of Insulin Used |
37; 30; 39; 2; 9; 2 | — |
| SECONDARY Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD) |
0.7; 0.6; 0.7; 0.6; 0.6; 0.6 | — |
| SECONDARY Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD) |
0.3; 0.3; 0.3; 0.3; 0.3; 0.2 | — |
| SECONDARY Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day |
3.2; 3.4; 2.5 | — |
| SECONDARY Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges |
3.0; 1.6; 1.1; 1.8; 1.6; 0.9 | — |
| SECONDARY Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges |
19.3; 25.9; 26.4; 19.3; 25.5; 25.4 | — |
| SECONDARY Number of Consultations |
— | — |
| SECONDARY Number of Pods/Infusion Assemblies Falling Off Prematurely |
— | — |
| SECONDARY Average Time Spent on Infusion Assembly |
— | — |
| SECONDARY Number of Participants With Skin Reactions (Including Type and Intensity) |
2; 1; 1; 0; 0; 0 | — |
| SECONDARY Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard |
— | — |
| SECONDARY Amount of Waste, Inferred by Total Material Consumption |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT03478969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.