Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05544643
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2022-09-08
Brief Title:
Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the Extended Mio 30 infusion set EM30IS 7-day functioning compared to the regular Mio 30 infusion set M30IS 3-day functioning The study will be carried out in adult patients with type 1 diabetes
Secondary objective to evaluate the differences in glucose control between the infusion set currently used by participants Medtronic Quick set infusion sets and the Medtronic Mio 30 Infusion Set
Secondary objective to evaluate the differences in glucose control between the infusion set currently used by participants Medtronic Quick set infusion sets and the Medtronic Mio 30 Infusion Set
Detailed Description:
This is a 1-center prospective open-label cross-over controlled study with type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring CGM
A total of up to 40 subjects will be enrolled in order to have 20 subjects meeting eligibility criteria Eligible patients meeting the enrollment and randomization criteria will enter a run-in period of up to 1 month for device adaptation After the run- in phase The participants will enter the first study part participants will be randomized into 2 arms each arm will undergo 2 phases In each phase a different type of infusion set will be evaluated Each evaluation will be for 1 month The order will be determined by the randomization process
Arm A Quick set infusion set- M30IS First phase Quick set second phase Mio 30
Arm B M30IS- Quick set infusion set First phase Mio 30 second phase Quick set infusion set
Trial Arm A Subjects will be randomized to a group who will be using the Quick set infusion set for the initial Phase All patients will be trained on the use of the Quick set infusion set by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another Quick set infusion set
After 1 month the patients will return to a visit return all the extracted catheters sets and will switch to the M30IS entering Phase 2 All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS 1 month the patients will return all the extracted catheters sets
Trial Arm B Subjects will be randomized to a group who will be using the Mio 30 infusion set M30IS for the second Phase All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS
After 1 month the patients will return to a visit return all the extracted catheters sets and will switch to the Quick set infusion set entering Phase 2 All patients will be trained at this visit on the use of the Quick set infusion set by site staff and demonstrate proficiency in the use of the Quick set infusion set All subjects will be instructed to change sets every 3 days or at set failure replace with another Quick set infusion set 1 month the patients will return all the extracted catheters sets
After completing the first study part participants will be randomized again into 2 arms each arm will undergo 2 phases In each phase a different type of infusion set will be evaluated Each evaluation will be for 4 sets up to 28 days The order will be determined by the randomization process
Arm A M30IS - EM30IS First phase Mio 30 second phase Extended Mio 30
Arm B EM30IS - M30IS First phase Extended Mio 30 second phase Mio 30 Trial Arm A Subjects will be randomized to a group who will be using the Mio 30 infusion set M30IS for the Phase 1 All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS
At day 12 or after using 4 sets set used defined as a set that was used for more than 6 hours the patients will return to a visit return all the extracted catheters sets and will switch to the Extended Mio 30 infusion set EM30IS entering Phase 2 All patients will be trained at this visit on the use of the EM30IS by site staff and demonstrate proficiency in the use of the EM30IS All subjects will be instructed to change sets every 7 days or at set failure replace with another EM30IS After 28 days or after using 4 sets the patients will return all the extracted catheters sets
Trial Arm B Subjects will be randomized to a group who will be using the EM30IS for the initial Phase All patients will be trained on the use of the EM30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 7 days or at set failure replace with another EM30IS
At day 28 or after using 4 sets set used defined as a set that was used for more than 6 hours the patients will return to a visit return all the extracted catheters sets and will switch to the M30IS entering Phase 2 All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS After 12 days or after using 4 sets the patients will all the extracted catheters sets
Each subject will wear MiniMed 780G670G insulin system Each subject will be given for the first study part 11 infusion sets each to wear each infusion set for at least the labelled use time 3 days for M30IS or 3 days for Quick set infusin set or until infusion set failure if this occurs before 3 daysfor the second part 4 infusion sets each to wear each infusion set for at least the labelled use time 3 days for M30IS or 7 days for EM30IS or until infusion set failure if this occurs before 3 days
A total of up to 40 subjects will be enrolled in order to have 20 subjects meeting eligibility criteria Eligible patients meeting the enrollment and randomization criteria will enter a run-in period of up to 1 month for device adaptation After the run- in phase The participants will enter the first study part participants will be randomized into 2 arms each arm will undergo 2 phases In each phase a different type of infusion set will be evaluated Each evaluation will be for 1 month The order will be determined by the randomization process
Arm A Quick set infusion set- M30IS First phase Quick set second phase Mio 30
Arm B M30IS- Quick set infusion set First phase Mio 30 second phase Quick set infusion set
Trial Arm A Subjects will be randomized to a group who will be using the Quick set infusion set for the initial Phase All patients will be trained on the use of the Quick set infusion set by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another Quick set infusion set
After 1 month the patients will return to a visit return all the extracted catheters sets and will switch to the M30IS entering Phase 2 All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS 1 month the patients will return all the extracted catheters sets
Trial Arm B Subjects will be randomized to a group who will be using the Mio 30 infusion set M30IS for the second Phase All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS
After 1 month the patients will return to a visit return all the extracted catheters sets and will switch to the Quick set infusion set entering Phase 2 All patients will be trained at this visit on the use of the Quick set infusion set by site staff and demonstrate proficiency in the use of the Quick set infusion set All subjects will be instructed to change sets every 3 days or at set failure replace with another Quick set infusion set 1 month the patients will return all the extracted catheters sets
After completing the first study part participants will be randomized again into 2 arms each arm will undergo 2 phases In each phase a different type of infusion set will be evaluated Each evaluation will be for 4 sets up to 28 days The order will be determined by the randomization process
Arm A M30IS - EM30IS First phase Mio 30 second phase Extended Mio 30
Arm B EM30IS - M30IS First phase Extended Mio 30 second phase Mio 30 Trial Arm A Subjects will be randomized to a group who will be using the Mio 30 infusion set M30IS for the Phase 1 All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS
At day 12 or after using 4 sets set used defined as a set that was used for more than 6 hours the patients will return to a visit return all the extracted catheters sets and will switch to the Extended Mio 30 infusion set EM30IS entering Phase 2 All patients will be trained at this visit on the use of the EM30IS by site staff and demonstrate proficiency in the use of the EM30IS All subjects will be instructed to change sets every 7 days or at set failure replace with another EM30IS After 28 days or after using 4 sets the patients will return all the extracted catheters sets
Trial Arm B Subjects will be randomized to a group who will be using the EM30IS for the initial Phase All patients will be trained on the use of the EM30IS by site staff and will be asked to demonstrate proficiency All subjects will be instructed to change sets every 7 days or at set failure replace with another EM30IS
At day 28 or after using 4 sets set used defined as a set that was used for more than 6 hours the patients will return to a visit return all the extracted catheters sets and will switch to the M30IS entering Phase 2 All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency All subjects will be instructed to change sets every 3 days or at set failure replace with another M30IS After 12 days or after using 4 sets the patients will all the extracted catheters sets
Each subject will wear MiniMed 780G670G insulin system Each subject will be given for the first study part 11 infusion sets each to wear each infusion set for at least the labelled use time 3 days for M30IS or 3 days for Quick set infusin set or until infusion set failure if this occurs before 3 daysfor the second part 4 infusion sets each to wear each infusion set for at least the labelled use time 3 days for M30IS or 7 days for EM30IS or until infusion set failure if this occurs before 3 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None