MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

Medtrum

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Biological: Lab A1C; Device: Medtrum A7+ insulin Pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT04223973

2019-A02566-51

Details and patient eligibility

About

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

Full 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)

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Active Group

Experimental group

Description:

Using the Medtrum Pump A7+ during 3 months

Treatment:

Device: Medtrum A7+ insulin Pump

Biological: Lab A1C

Control Group

Active Comparator group

Description:

using the usual Insulet Patch pump

Treatment:

Biological: Lab A1C