MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS) (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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Medtrum A7+ insulin Pump; Biological: Lab A1C

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 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)

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Essones
    • Corbeil-Essonnes, Essones, France, 91100
      • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtrum France
• Investigators: Principal Investigator: Freddy PENFORNIS, Centre Hospitalier Francilien, Corbeil

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Insulin Pump; diabetes management
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2019-A02566-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No