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: Biological: Lab A1C; Device: Medtrum A7+ insulin 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)

• Study Type: Interventional
• Enrollment (Actual): 93
• 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

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 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.

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	Biological: Lab A1C; Measure of Lab A1C at baseline and end of study; Device: Medtrum A7+ insulin Pump; Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)
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 on the Last 10 Weeks	A1C will be estimated by a Continuous Glucose Measurement (FreeStyle Libre®) for all patients, at baseline and end of the study (12 weeks). 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).	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months	A1C is expressed in percentage based on Laboratory measurement. A1C is obtained & measured from a blood sample.	Month 3
Compare The Time Spent in Range	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.	Month 3
Compare Patients Pump Satisfaction	Question: Overall, how satisfied were you with the pump? Satisfaction to be measured by a Patient Self- questionnaire through a Likert scale ranking from 1 (the less) to 5 (the most).	Month 3
Compare Patients PDM Satisfaction	Question: How to qualify the discretion of use of the PDM (Personal Diabetes Manager) of the pump? the satisfaction scale went from 1 (very unsatisfied) to 5 (very satisfied)	Month 3
Number of Participants With at Least One Pump Occlusion	occlusion reported by patient	Month 3

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): August 16, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Insulin Pump; diabetes management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; 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