EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

NCT ID: NCT06684561

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-04-30

Brief Summary

Study 1:

The purpose of this study is to evaluate safety and efficacy of Photon infusion sets (PIS) with new PFAS-free cannula (catheter) in adult patients with Type 1 diabetes for up to 10 days and 6 hours.

This is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780G insulin pump therapy with Guardian™ 4 Continuous Glucose Monitoring (CGM). All subjects will be instructed to change infusion sets every 246 hours (10 days & 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of <6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

Photon infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. Subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the Extended reservoir). The infusion set(s) or reservoir(s) can be replaced independent of each other. The date and time of each infusion set insertion will be recorded in a Daily Log (Diary) which will include the causes of early removal, if occurs.

Study 2: If Study 1 is successful, the same study designed as illustrated in Figure 1 may be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days & 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

defined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of <6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

if study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users

Group Type: EXPERIMENTAL

PIS

Intervention Type: DEVICE

All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days & 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

defined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of <6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

if study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users

Interventions

PIS

All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days & 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

defined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of <6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

if study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of type 1 diabetes for at least one year

2. Using a MiniMed™ 780G Insulin pump with Guardian sensor

3. Age 18 to 80 years

4. Hemoglobin A1c level less than or equal to 10%

5. Not currently known to be pregnant, nor planning pregnancy during the study.

6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.

2. Pregnant or lactating females

3. Subject has Glycosylated hemoglobin (HbA1c)< 10 % at time of screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Amir Tirosh

Prof. Amir Tirosh

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc

Role: CONTACT

maya.laronhirsh@sheba.health.gov.il

Maya.Laron-hirsh@sheba.gov.il

Sapir Barel

Role: CONTACT

Sapir.Barel@sheba.gov.il

0526177726

Other Identifiers

Sheba-24-1530-AT-CTIL

Identifier Type: -

Identifier Source: org_study_id