Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05544643 |
Other study ID # |
Sheba-21-8739-at-ctil |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 4, 2022 |
Est. completion date |
August 4, 2022 |
Study information
Verified date |
September 2022 |
Source |
Sheba Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 MiniMedâ„¢ 780G/670G 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 days.for 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.