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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 Guardianâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIS | 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 |
| 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.
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc | Contact | Maya.Laron-hirsh@sheba.gov.il | maya.laronhirsh@sheba.health.gov.il | |
| Sapir Barel | Contact | 0526177726 | Sapir.Barel@sheba.gov.il |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |