N/A
Completed N=93
MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)
Source: ClinicalTrials.gov NCT04223973 ↗Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Aug 2024
Primary outcomePrimary: Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks — 7.345; 7.347 estimated percentage of hemoglobin A1C
Summary
Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks |
7.345; 7.347 | — |
| SECONDARY Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months |
-0.057; 0.007 | — |
| SECONDARY Compare The Time Spent in Range |
56.5; 58.4 | — |
| SECONDARY Compare Patients Pump Satisfaction |
3.5; 4.1 | — |
| SECONDARY Compare Patients PDM Satisfaction |
4.4; 3.8 | — |
| SECONDARY Number of Participants With at Least One Pump Occlusion |
24; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Patient with type 1 or 2 diabetes, 18 years of age and over
- Patients already equipped with Omnipod® ® (INSULET) insulin patch pump and Abbott FreeStyleLibre sensor®.
- A1C ranking from : >= 6,5% to 60 IU
- Patients not suitable for suing insulin pump such as: severe psychiatric disorders, rapidly progressing ischemic or proliferative retinopathy before laser treatment, and exposure to high magnetic fields
- Patients allergic to nickel and adhesive
- Pregnant women, breastfeeding women
- Or any other criteria as appreciated by the study investigator.
Data sourced from ClinicalTrials.gov (NCT04223973). 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.