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Completed

NCT Number: NCT04223973

MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier Sud Francilien

Corbeil-Essonnes, Essones, 91100, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medtrum A7+ insulin Pump

Device

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

Lab A1C

Biological

Measure of Lab A1C at baseline and end of study

Primary outcomes

  1. Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks

    Time frame: Month 3

    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).

Secondary outcomes

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

    Time frame: Month 3

    A1C is expressed in percentage based on Laboratory measurement. A1C is obtained & measured from a blood sample.

  2. Compare The Time Spent in Range

    Time frame: Month 3

    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. Compare Patients Pump Satisfaction

    Time frame: Month 3

    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).

  4. Compare Patients PDM Satisfaction

    Time frame: Month 3

    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)

  5. Number of Participants With at Least One Pump Occlusion

    Time frame: Month 3

    occlusion reported by patient

Sponsors and collaborators

Lead sponsor

Medtrum France

Industry

Registry information

Official study title

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

Acronym: MedInPS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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