Diabetes MellitusMedInPSNCT04223973

MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

A study testing Medtrum A7+ insulin Pump and Lab A1C in people with Diabetes Mellitus, run by Medtrum France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Medtrum A7+ insulin Pump and Lab A1C
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteFrance
Study dates: 29 Jan 2020to 1 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

- 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.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre hospitalier Sud Francilien
Corbeil-Essonnes, Essones, 91100

Other trials in France

About this study

Official title: 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

Read the 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)

Conditions: Diabetes Mellitus
Being tested: Medtrum A7+ insulin Pump, Lab A1C
Keywords: diabetes management, Insulin Pump
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtrum A7+ insulin PumpDevice
Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)
Lab A1CBiological
Measure of Lab A1C at baseline and end of study

Study groups in NCT04223973
Study group	Role	What they receive
Active Group	Experimental	Using the Medtrum Pump A7+ during 3 months Receives: Device: Medtrum A7+ insulin Pump; Biological: Lab A1C
Control Group	Active comparator	using the usual Insulet Patch pump Receives: Biological: Lab A1C

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Month 3

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Month 3
Number of Participants With at Least One Pump Occlusion
occlusion reported by patient
Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 20201 Jun 2021

First posted13 Jan 2020
Study start29 Jan 2020
Primary completion1 Mar 2021
Study completion1 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04223973
Sponsor's protocol ID: 2019-A02566-51
Acronym: MedInPS
Status last verified: Mar 2024
First submitted: 11 Dec 2019
Last updated: 16 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37616289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump
ClinicalTrials.gov ID: NCT04223973
Acronym / sponsor ID: MedInPS / 2019-A02566-51
Conditions: Diabetes Mellitus
Keywords: diabetes management, Insulin Pump
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Medtrum FranceIndustry (pharma, biotech, devices)
Study start: 29 Jan 2020 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 13 Jan 2020 (actual)
Results: Posted 16 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.

Arm	Type	Receives
Active Group	Experimental	Device: Medtrum A7+ insulin Pump, Biological: Lab A1CUsing the Medtrum Pump A7+ during 3 months
Control Group	Active comparator	Biological: Lab A1Cusing the usual Insulet Patch pump

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

- 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtrum A7+ insulin PumpUse of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)	Device	Active Group
Lab A1CMeasure of Lab A1C at baseline and end of study	Biological	Active Group, Control Group

Primary outcome

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).

5 secondary outcomes

Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months
Time frame: Month 3
Compare The Time Spent in Range
Time frame: Month 3
Compare Patients Pump Satisfaction
Time frame: Month 3
Compare Patients PDM Satisfaction
Time frame: Month 3
Number of Participants With at Least One Pump Occlusion
Time frame: Month 3

Results and safety

Results posted to the registry on 16 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medtrum A7+ Insulin Pump	48	35
Insulet Patch Pump	45	43

Primary outcome: Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks

Time frame: Month 3. Least squares mean (Standard Deviation). Unit: estimated percentage of hemoglobin A1C

Measure	Medtrum A7+ Insulin Pump n = 35	Insulet Patch Pump n = 43
Value	7.345 (0.094)	7.347 (0.085)

Population analysed: population analysed is population per protocol: population wearing the sensor and using the pump at least 90% of time over the last 10 weeks of protocol (out of 12 weeks total study duration)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medtrum A7+ Insulin Pump	1 of 48 (2.1%)	7 of 48 (14.6%)	0 of 48
Insulet Patch Pump	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37616289Amadou 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Freddy PENFORNIS principal investigator

Centre Hospitalier Francilien, Corbeil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medtrum A7+ insulin Pump and Lab A1C in people with Diabetes Mellitus, run by Medtrum France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04223973, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.