Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes for at least one year
- Age 18 to 80 years
- Not currently known to be pregnant, nor planning pregnancy during the study.
- Willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Pregnant or lactating females
Sites / Locations
- Sheba Medical Center
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A - M30IS vs. EM30IS. First phase Mio 30, second phase Extended Mio 30.
B - EM30IS vs. M30IS. First phase Extended Mio 30, second phase Mio 30
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.
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.