MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump

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

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)

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.