EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 40
• From Dec 2024 to the primary completion date, Dec 2025
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov