MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

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

Detailed Description
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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 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…) Colllection of Glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Medtrum A7+ insulin Pump
* Biological: Lab A1C


Participation Criteria
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Eligibility Criteria
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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 UI 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group<br>Using the Medtrum Pump A7+ during 3 months | Device: Medtrum A7+ insulin Pump<br>* Use of the Medtrum pump during 3 months in combination with a CGM<br>Biological: Lab A1C<br>* Measure of Lab A1C at baseline and end of study<br>|
| Active Comparator: Control Group<br>using the usual Insulet Patch pump | Biological: Lab A1C<br>* Measure of Lab A1C at baseline and end of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of A1C based on average blood glucose measured by continuous glucose sensor | A1C will be estimated by a Continuous Glucose Measurement (FreeStyle Libre®) for all patients, at baseline and end of the study. The main objective is to demonstrate Non-inferiority efficacy (PP then ITT) of Medtrum A7+ insulin patch pump vs Insulet Omnipod® insulin patch pump (2 randomized groups). For the primary outcome, A1C will be estimated and appear in percentage based on assessment done by a Continuous Glucose Monitoring system. The A1C obtained in real life for the group using the comparator pump (Omnipod®) is estimated at 7,8%. Assuming that blood glucose level will be the same with Medtrum pump and based on a defined non-inferiority margin ∆ = + 0,4 (following FDA Guidance for Industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report Patients' physiological A1C difference -as measured at the laboratory-between the active group ( Medtrum Pump) vs Control Group (comparator device) in order to assess non inferiority | A1C is expressed in percentage based on Laboratory measurement. A1C is obtained & measured from a blood sample. | 3 months | 
| Compare The Time spent in Range for the active group ( Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority | Glycemic Time In Range is the Time spent in the target. It is expressed in % of time. Time in Range is automatically calculated from the Sensor data wear. | 3 months | 
| Compare Patients satisfaction for the active group ( Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority | Number of patients satisfied is expressed in percentage. Satisfaction to be measured by a Patient Self- questionnaire through a Visual Scoring scale ranking from 1 (the less) to 5 (the most). | 3 months | 
| Compare number of pump dysfonction for the active group (Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority | (1) Number of technical issues related to the devices uses (reported by patient) | 3 months | 
| Compare pump tolerance for the active group (Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority | Number of incidents related to tolerance of the devices (reported by patient) Severity of incidents related to tolerance of the devices (reported by patient) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Pump, diabetes management