MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

Diabetes Mellitus Clinical Trial

— MedInPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223973
• Other study ID #: 2019-A02566-51
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Medtrum France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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…)

• Colllection of Glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 UI 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 ?elds

• Patients allergic to nickel and adhesive

• Pregnant women, breastfeeding women

• Or any other criteria as appreciated by the study investigator.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Medtrum A7+ insulin Pump
Use of the Medtrum pump during 3 months in combination with a CGM

Biological:
• Lab A1C
Measure of Lab A1C at baseline and end of study

Locations

Country	Name	City	State
France	Centre hospitalier Sud Francilien	Corbeil-Essonnes	Essones

Sponsors (1)

Lead Sponsor	Collaborator
Medtrum France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of A1C based on average blood glucose measured by continuous glucose sensor	A1C will be estimated by a Continuous Glucose Measurement (FreeStyle Libre®) for all patients, at baseline and end of the study. 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).	3 months
Secondary	Report Patients' physiological A1C difference -as measured at the laboratory-between the active group ( Medtrum Pump) vs Control Group (comparator device) in order to assess non inferiority	A1C is expressed in percentage based on Laboratory measurement. A1C is obtained & measured from a blood sample.	3 months
Secondary	Compare The Time spent in Range for the active group ( Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority	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 months
Secondary	Compare Patients satisfaction for the active group ( Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority	Number of patients satisfied is expressed in percentage. Satisfaction to be measured by a Patient Self- questionnaire through a Visual Scoring scale ranking from 1 (the less) to 5 (the most).	3 months
Secondary	Compare number of pump dysfonction for the active group (Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority	(1) Number of technical issues related to the devices uses (reported by patient)	3 months
Secondary	Compare pump tolerance for the active group (Medtrum Pump) vs Control Group Patients (comparator device) in order to assess non inferiority	Number of incidents related to tolerance of the devices (reported by patient); Severity of incidents related to tolerance of the devices (reported by patient)	3 months