Clinical trial NCT04223973: MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)
Official title: Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes management
Insulin Pump
Lead sponsor: Medtrum France
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.
Primary purpose: TREATMENT

Brief summary: Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump

Detailed description: Compare the daily use of two single usage patch pumps and demonstrate the interest of use of the A7+TouchCare® (Medtrum) patch pump for type 1 \& 2 diabetes management.

Main objective is an estimation of Patients A1C (Glycated Haemoglobin) based on the average blood glucose (obtained from a Flash glucose monitoring) and to compare it in both groups.

Secondary objectives:

* comparison of mean A1C (laboratory values) between the two groups at Baseline and study end. Comparison to be established in a non-inferiority
* Observe Skin \& overall Tolerance, Technical incidents with the device (failure, disconnection, catheter obstruction...)
* Collection of Glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)

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 \<= 9.5%
* Any type of rapid insulin except FIASP (which can be substituted if necessary) with 60 IU max per day (unauthorized use of insulin supplements by pen injector)
* Patient able to receive and understand study information, give written informed consent, and easily participate to the trial
* Patient affiliated to the French social security system

Exclusion Criteria:

* - Patient already participating in another study
* Patient under the protection of justice or under guardianship or curatorship
* Type 2 diabetic patient requiring a daily insulin dose \> 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.

Primary outcomes:
measure: Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks
timeFrame: Month 3
Secondary outcomes:
measure: Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months
timeFrame: Month 3
measure: Compare The Time Spent in Range
timeFrame: Month 3
measure: Compare Patients Pump Satisfaction
timeFrame: Month 3
measure: Compare Patients PDM Satisfaction
timeFrame: Month 3
measure: Number of Participants With at Least One Pump Occlusion
timeFrame: Month 3
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre hospitalier Sud Francilien
state: Essones
Study officials:
affiliation: Centre Hospitalier Francilien, Corbeil
name: Freddy PENFORNIS
role: PRINCIPAL_INVESTIGATOR
References: