Trial Outcomes & Findings for MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS) (NCT NCT04223973)
NCT ID: NCT04223973
Last Updated: 2024-08-16
Results Overview
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).
COMPLETED
NA
93 participants
Month 3
2024-08-16
Participant Flow
Date of recruitment: January 2020 to February 2021 \> total duration 13 months 8 investigational centres mainly hospitals (General and University Hospitals)
Due to Covid 19 pandemia some clinical sites Research Department decided to stop recruitment or put interventional arm of the protocol of test on hold. As consequence of this, some participants where withdrawn. Mainly in Active group as in the control group patients were using their usual devices and treatment and they resumes follow up visits as usual.
Participant milestones
| Measure |
Medtrum A7+ Insulin Pump
Using the Medtrum Pump A7+ during 3 months
Medtrum A7+ insulin Pump: Use of the Medtrum pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
Patients using their usual device: Insulet Patch pump
Lab A1C: Measure of Lab A1C at baseline and end of study Use of their usual pomp and usual CGM during 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
35
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
2
|
Reasons for withdrawal
| Measure |
Medtrum A7+ Insulin Pump
Using the Medtrum Pump A7+ during 3 months
Medtrum A7+ insulin Pump: Use of the Medtrum pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
Patients using their usual device: Insulet Patch pump
Lab A1C: Measure of Lab A1C at baseline and end of study Use of their usual pomp and usual CGM during 3 months
|
|---|---|---|
|
Overall Study
Patients 'withdrawal due to Covid 19 impact on study recruitment/follow-up on site
|
5
|
0
|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
patients reported product dysfunctions and decided to stop the study
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Medtrum A7+ Insulin Pump
n=48 Participants
Patients use the Medtrum A7+ insulin Pump during 3 months in combination with a Continuous Glucose Monitoring (CGM)
|
Insulet Patch Pump
n=45 Participants
Patients carry on using their usual Insulet Patch pump in combination with a CGM
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Population age
|
49.4 years
STANDARD_DEVIATION 11.7 • n=48 Participants
|
50.3 years
STANDARD_DEVIATION 13.6 • n=45 Participants
|
49.8 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=48 Participants
|
29 Participants
n=45 Participants
|
53 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=48 Participants
|
16 Participants
n=45 Participants
|
40 Participants
n=93 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI (kg/m²)
|
26.5 kg/m^2
STANDARD_DEVIATION 4.1 • n=48 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=45 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 4.2 • n=93 Participants
|
|
Diabetes type
Type 1 diabetics
|
41 Participants
n=48 Participants
|
43 Participants
n=45 Participants
|
84 Participants
n=93 Participants
|
|
Diabetes type
Type 2 diabetics
|
7 Participants
n=48 Participants
|
2 Participants
n=45 Participants
|
9 Participants
n=93 Participants
|
|
Time since diabetes diagnosis
|
22.7 years
STANDARD_DEVIATION 11.1 • n=48 Participants
|
22.2 years
STANDARD_DEVIATION 11.5 • n=45 Participants
|
22.5 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
|
Time since initiation of insulin pump treatment
|
5.4 years
STANDARD_DEVIATION 4.3 • n=48 Participants
|
7.1 years
STANDARD_DEVIATION 6.7 • n=45 Participants
|
6.2 years
STANDARD_DEVIATION 5.7 • n=93 Participants
|
|
A1C measured at lab Vs sensor estimation
Laboratory A1C
|
7.8 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.7 • n=48 Participants
|
7.8 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.8 • n=45 Participants
|
7.8 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.7 • n=93 Participants
|
|
A1C measured at lab Vs sensor estimation
Sensor estimated A1C
|
7.5 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.9 • n=48 Participants
|
7.4 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.8 • n=45 Participants
|
7.4 percentage of hemoglobin A1C
STANDARD_DEVIATION 0.9 • n=93 Participants
|
|
Insulin /day
Daily basal dose
|
18.7 IU/day
STANDARD_DEVIATION 10.0 • n=48 Participants
|
16.1 IU/day
STANDARD_DEVIATION 5.9 • n=45 Participants
|
17.5 IU/day
STANDARD_DEVIATION 8.4 • n=93 Participants
|
|
Insulin /day
Daily Bolus Dose
|
18.7 IU/day
STANDARD_DEVIATION 10.9 • n=48 Participants
|
21.5 IU/day
STANDARD_DEVIATION 9 • n=45 Participants
|
20 IU/day
STANDARD_DEVIATION 10.1 • n=93 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: 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)
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).
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=35 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks
|
7.345 estimated percentage of hemoglobin A1C
Standard Deviation 0.094
|
7.347 estimated percentage of hemoglobin A1C
Standard Deviation 0.085
|
SECONDARY outcome
Timeframe: Month 3Population: population per protocol as population wearing their sensor 90% of time and wearing their pump 90% of time over the last 10 weeks of the test duration
A1C is expressed in percentage based on Laboratory measurement. A1C is obtained \& measured from a blood sample.
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=35 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months
|
-0.057 percentage of laboratory hemoglobin A1C
Standard Deviation 0.475
|
0.007 percentage of laboratory hemoglobin A1C
Standard Deviation 0.496
|
SECONDARY outcome
Timeframe: Month 3Population: Modified Intent-To-Treat population (ITTm) as population with FSL (FreeStyle Libre) available data at 3 months
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.
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=36 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Compare The Time Spent in Range
|
56.5 percentage of time spent in the target
Standard Deviation 12.3
|
58.4 percentage of time spent in the target
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Month 3Population: population ITTm as population with available questionnaire data
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).
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=36 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Compare Patients Pump Satisfaction
|
3.5 units on a scale
Standard Deviation 1.2
|
4.1 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Month 3Population: population ITTm as population with available questionnaire data
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)
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=36 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Compare Patients PDM Satisfaction
|
4.4 units on a scale
Standard Deviation 0.8
|
3.8 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Month 3Population: population ITTm as population with available questionnaire data
occlusion reported by patient
Outcome measures
| Measure |
Medtrum A7+ Insulin Pump
n=36 Participants
Patients Using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
Insulet Patch Pump
n=43 Participants
Patients using their usual Insulet Patch pump in combination with a CGM
Lab A1C: Measure of Lab A1C at baseline and end of study
|
|---|---|---|
|
Number of Participants With at Least One Pump Occlusion
|
24 Participants
|
12 Participants
|
Adverse Events
Medtrum A7+ Insulin Pump
Insulet Patch Pump
Serious adverse events
| Measure |
Medtrum A7+ Insulin Pump
n=48 participants at risk
Patients using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
|
Insulet Patch Pump
n=45 participants at risk
Patients using their usual insulin pump in combination with a CGM during 3 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Ketonemia
|
2.1%
1/48 • Number of events 1 • 3 months
|
0.00%
0/45 • 3 months
|
Other adverse events
| Measure |
Medtrum A7+ Insulin Pump
n=48 participants at risk
Patients using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM
|
Insulet Patch Pump
n=45 participants at risk
Patients using their usual insulin pump in combination with a CGM during 3 months
|
|---|---|---|
|
General disorders
Bleeding at the injection site
|
8.3%
4/48 • Number of events 4 • 3 months
|
4.4%
2/45 • Number of events 2 • 3 months
|
|
General disorders
Pain at the injection site
|
6.2%
3/48 • Number of events 3 • 3 months
|
0.00%
0/45 • 3 months
|
Additional Information
Mrs Melanie MARMOUNIER-WILHLEM- Commercial DIrector
Medtrum France
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place