EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: PIS

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc; Phone Number: Maya.Laron-hirsh@sheba.gov.il; Email: maya.laronhirsh@sheba.health.gov.il
• Study Contact Backup: Name: Sapir Barel; Phone Number: 0526177726; Email: Sapir.Barel@sheba.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	The primary outcome is to have no more than 16% of infusion set failures due to "unexplained hyperglycemia" Definition of unexplained hyperglycemia: o The study meter glucose >250 mg/dL (>3 hours post-meal) which may include time during subject's sleeping hours.; Failure of a correction dose(s) to lower the study meter glucose by at least 50 mg/dL within 1 hour.; One additional correction dose may be given after first correction dose and recommended to use the bolus calculator	12 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: insulin pumps; Infusion sets; AID system
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Sheba-24-1530-AT-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No