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Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Experimental | Using the Medtrum Pump A7+ during 3 months |
|
| Control Group | Active Comparator | using the usual Insulet Patch pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtrum A7+ insulin Pump | Device | Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| Compare The Time Spent in Range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freddy PENFORNIS | Centre Hospitalier Francilien, Corbeil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier Sud Francilien | Corbeil-Essonnes | Essones | 91100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37616289 | Derived | 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. |
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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.
Date of recruitment: January 2020 to February 2021 > total duration 13 months 8 investigational centres mainly hospitals (General and University Hospitals)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol population (78 participants)
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| ID | Title | Description |
|---|---|---|
| BG000 | Medtrum A7+ Insulin Pump | Patients use the Medtrum A7+ insulin Pump during 3 months in combination with a Continuous Glucose Monitoring (CGM) |
| BG001 | Insulet Patch Pump | Patients carry on using their usual Insulet Patch pump in combination with a CGM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Measures at baseline were collected in a Case report form and check with Patient medical record |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Least Squares Mean | Standard Deviation | estimated percentage of hemoglobin A1C | Month 3 |
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medtrum A7+ Insulin Pump | Patients using the Medtrum A7+ insulin Pump during 3 months in combination with a CGM |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ketonemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at the injection site | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Melanie MARMOUNIER-WILHLEM- Commercial DIrector | Medtrum France | +33620591224 | melanie.marmounier@medtrum.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2020 | Jan 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Jan 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Randomized controlled trial (RCT), open-label with two arms, multicentric national, prospective, non-inferiority methodology versus reimbursed comparator.
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| Lab A1C | Biological | Measure of Lab A1C at baseline and end of study |
|
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.
| 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). | 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) | Month 3 |
| Number of Participants With at Least One Pump Occlusion | occlusion reported by patient | Month 3 |
| patients reported product dysfunctions and decided to stop the study |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI (kg/m²) | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes type | Count of Participants | Participants |
|
| Time since diabetes diagnosis | Mean | Standard Deviation | years |
|
| Time since initiation of insulin pump treatment | Mean | Standard Deviation | years |
|
| A1C measured at lab Vs sensor estimation | Mean | Standard Deviation | percentage of hemoglobin A1C |
|
| Insulin /day | Mean | Standard Deviation | IU/day |
|
| ID | Title | Description |
|---|
| OG000 | Medtrum A7+ Insulin Pump | 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 |
| OG001 | Insulet Patch Pump | Patients using their usual Insulet Patch pump in combination with a CGM Lab A1C: Measure of Lab A1C at baseline and end of study |
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | percentage of laboratory hemoglobin A1C | Month 3 |
|
|
|
| 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. | Modified Intent-To-Treat population (ITTm) as population with FSL (FreeStyle Libre) available data at 3 months | Posted | Mean | Standard Deviation | percentage of time spent in the target | Month 3 |
|
|
|
| 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). | population ITTm as population with available questionnaire data | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| 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) | population ITTm as population with available questionnaire data | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| Secondary | Number of Participants With at Least One Pump Occlusion | occlusion reported by patient | population ITTm as population with available questionnaire data | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 7 |
| 48 |
| EG001 | Insulet Patch Pump | Patients using their usual insulin pump in combination with a CGM during 3 months | 0 | 45 | 0 | 45 | 2 | 45 |
| Pain at the injection site | General disorders | Systematic Assessment |
|
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