NCT04223973

MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Medtrum France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Medtrum A7+ insulin Pump	Use of the Medtrum pump during 3 months in combination with a CGM (Continuous Glucose Measurement)
BIOLOGICAL	Lab A1C	Measure of Lab A1C at baseline and end of study

Timeline

• Start date: 2020-01-29
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2020-01-13
• Last updated: 2024-08-16
• Results posted: 2024-08-16

Locations

1 site across 1 country: France