MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

NCT04223973 | Completed Results DMC

• 1 other identifier: 2019-A02566-51
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

diabetes management; Insulin Pump

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months

  Month 3

• Compare The Time Spent in Range

  Month 3

• Compare Patients Pump Satisfaction

  Month 3

• Compare Patients PDM Satisfaction

  Month 3

• Number of Participants With at Least One Pump Occlusion

  Month 3

Study Arms (2)

Active Group

EXPERIMENTAL

Using the Medtrum Pump A7+ during 3 months

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

Control Group

ACTIVE COMPARATOR

using the usual Insulet Patch pump

Biological: Lab A1C

Interventions

Medtrum A7+ insulin Pump DEVICE

Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)

Active Group

Lab A1C BIOLOGICAL

Measure of Lab A1C at baseline and end of study

Active Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Medtrum France: lead

Study Sites (1)

Centre hospitalier Sud Francilien

Corbeil-Essonnes, Essones, 91100, France

Location

Related Publications (1)

• Amadou C, Melki V, Allain J, Clavel S, Gouet D, Chaillous L, Catargi B, Schaeplynck-Belicard P, Petit C, Thivolet C, Penfornis A. Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study. PLoS One. 2023 Aug 24;18(8):e0289684. doi: 10.1371/journal.pone.0289684. eCollection 2023.

  PMID: 37616289 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

15 patients were excluded from the PP Population due to protocol deviations (mainly premature discontinuation due to COVID 19 context), which occurred more frequently in the Touchcare group (13 patients vs 2 patients in the Omnipod group). Some differences in favour of the Omnipod pump may be explained since patients in this group used the Omnipod pump (and already satisfied with it) since several months or years, compared to only 1 to 3 months of use with the unknown Touchcare pump.

Results Point of Contact

• Title: Mrs Melanie MARMOUNIER-WILHLEM- Commercial DIrector
• Organization: Medtrum France

melanie.marmounier@medtrum.com

+33620591224

Study Officials

• Freddy PENFORNIS

  Centre Hospitalier Francilien, Corbeil

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 13, 2020
• Study Start: January 29, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 16, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)