Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set

NCT05544643 | Completed

• 1 other identifier: Sheba-21-8739-at-ctil
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Percentage of sets that failed due to unexplained hyperglycemia

  The primary outcome is to have no more than 16% of infusion set failures due to "unexplained hyperglycemia"

  6 months

Study Arms (2)

A - M30IS vs. EM30IS. First phase Mio 30, second phase Extended Mio 30.

EXPERIMENTAL

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.

Device: Medtronic Extended Mio 30 Infusion Set

B - EM30IS vs. M30IS. First phase Extended Mio 30, second phase Mio 30

EXPERIMENTAL

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.

Device: Medtronic Extended Mio 30 Infusion Set

Interventions

Medtronic Extended Mio 30 Infusion Set DEVICE

Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set

Also known as: Medtronic Mio 30 Infusion Set, Medtronic Quick set infusion set

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• Pregnant or lactating females

Sponsors & Collaborators

• Sheba Medical Center: lead
• Medtronic: collaborator

Study Sites (2)

Sheba Medical Center

Ramat Gan, 52662, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Amir Tirosh

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 16, 2022
• Study Start: August 4, 2022
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

IL (2)