Diabetes Mellitus
Conditions
Keywords
diabetes management, Insulin Pump
Brief summary
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)
Interventions
DEVICEMedtrum A7+ insulin Pump
Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)
BIOLOGICALLab A1C
Measure of Lab A1C at baseline and end of study
Sponsors
Medtrum France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months | Month 3 | A1C is expressed in percentage based on Laboratory measurement. A1C is obtained & measured from a blood sample. |
| Compare The Time Spent in Range | 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. |
| Compare Patients Pump Satisfaction | 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). |
| Compare Patients PDM Satisfaction | 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) |
| Number of Participants With at Least One Pump Occlusion | Month 3 | occlusion reported by patient |
Countries
France
Participant flow
Recruitment details
Date of recruitment: January 2020 to February 2021 \> total duration 13 months 8 investigational centres mainly hospitals (General and University Hospitals)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Medtrum A7+ Insulin Pump Patients use the Medtrum A7+ insulin Pump during 3 months in combination with a Continuous Glucose Monitoring (CGM) | 48 |
| Insulet Patch Pump Patients carry on using their usual Insulet Patch pump in combination with a CGM | 45 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | patients reported product dysfunctions and decided to stop the study | 3 | 0 |
| Overall Study | Patients 'withdrawal due to Covid 19 impact on study recruitment/follow-up on site | 5 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Medtrum A7+ Insulin Pump | Total | Insulet Patch Pump |
|---|---|---|---|
| A1C measured at lab Vs sensor estimation Laboratory A1C | 7.8 percentage of hemoglobin A1C STANDARD_DEVIATION 0.7 | 7.8 percentage of hemoglobin A1C STANDARD_DEVIATION 0.7 | 7.8 percentage of hemoglobin A1C STANDARD_DEVIATION 0.8 |
| A1C measured at lab Vs sensor estimation Sensor estimated A1C | 7.5 percentage of hemoglobin A1C STANDARD_DEVIATION 0.9 | 7.4 percentage of hemoglobin A1C STANDARD_DEVIATION 0.9 | 7.4 percentage of hemoglobin A1C STANDARD_DEVIATION 0.8 |
| Age, Customized Population age | 49.4 years STANDARD_DEVIATION 11.7 | 49.8 years STANDARD_DEVIATION 12.6 | 50.3 years STANDARD_DEVIATION 13.6 |
| BMI (kg/m²) | 26.5 kg/m^2 STANDARD_DEVIATION 4.1 | 26.0 kg/m^2 STANDARD_DEVIATION 4.2 | 25.4 kg/m^2 STANDARD_DEVIATION 4.3 |
| Diabetes type Type 1 diabetics | 41 Participants | 84 Participants | 43 Participants |
| Diabetes type Type 2 diabetics | 7 Participants | 9 Participants | 2 Participants |
| Insulin /day Daily basal dose | 18.7 IU/day STANDARD_DEVIATION 10 | 17.5 IU/day STANDARD_DEVIATION 8.4 | 16.1 IU/day STANDARD_DEVIATION 5.9 |
| Insulin /day Daily Bolus Dose | 18.7 IU/day STANDARD_DEVIATION 10.9 | 20 IU/day STANDARD_DEVIATION 10.1 | 21.5 IU/day STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 24 Participants | 53 Participants | 29 Participants |
| Sex: Female, Male Male | 24 Participants | 40 Participants | 16 Participants |
| Time since diabetes diagnosis | 22.7 years STANDARD_DEVIATION 11.1 | 22.5 years STANDARD_DEVIATION 11.3 | 22.2 years STANDARD_DEVIATION 11.5 |
| Time since initiation of insulin pump treatment | 5.4 years STANDARD_DEVIATION 4.3 | 6.2 years STANDARD_DEVIATION 5.7 | 7.1 years STANDARD_DEVIATION 6.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 45 |
| other Total, other adverse events | 7 / 48 | 2 / 45 |
| serious Total, serious adverse events | 1 / 48 | 0 / 45 |
Outcome results
Primary
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).
Time frame: Month 3
Population: 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)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Medtrum A7+ Insulin Pump | 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 |
| Insulet Patch Pump | Estimation of A1C (%) Based on Average Blood Glucose Measured by Continuous Glucose Sensor on the Last 10 Weeks | 7.347 estimated percentage of hemoglobin A1C | Standard Deviation 0.085 |
Secondary
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)
Time frame: Month 3
Population: population ITTm as population with available questionnaire data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtrum A7+ Insulin Pump | Compare Patients PDM Satisfaction | 4.4 units on a scale | Standard Deviation 0.8 |
| Insulet Patch Pump | Compare Patients PDM Satisfaction | 3.8 units on a scale | Standard Deviation 1 |
Secondary
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).
Time frame: Month 3
Population: population ITTm as population with available questionnaire data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtrum A7+ Insulin Pump | Compare Patients Pump Satisfaction | 3.5 units on a scale | Standard Deviation 1.2 |
| Insulet Patch Pump | Compare Patients Pump Satisfaction | 4.1 units on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: Month 3
Population: Modified Intent-To-Treat population (ITTm) as population with FSL (FreeStyle Libre) available data at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtrum A7+ Insulin Pump | Compare The Time Spent in Range | 56.5 percentage of time spent in the target | Standard Deviation 12.3 |
| Insulet Patch Pump | Compare The Time Spent in Range | 58.4 percentage of time spent in the target | Standard Deviation 13.1 |
Secondary
Number of Participants With at Least One Pump Occlusion
occlusion reported by patient
Time frame: Month 3
Population: population ITTm as population with available questionnaire data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtrum A7+ Insulin Pump | Number of Participants With at Least One Pump Occlusion | 24 Participants |
| Insulet Patch Pump | Number of Participants With at Least One Pump Occlusion | 12 Participants |
Secondary
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.
Time frame: Month 3
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtrum A7+ Insulin Pump | Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months | -0.057 percentage of laboratory hemoglobin A1C | Standard Deviation 0.475 |
| Insulet Patch Pump | Report Patients' Laboratory Hemoglobin A1C Difference Between Baseline and 3 Months | 0.007 percentage of laboratory hemoglobin A1C | Standard Deviation 0.496 |