Type 1 Diabetes MellitusNCT06684561
EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET
A study testing PIS in people with Type 1 Diabetes Mellitus, run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- PIS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMed™ 780G Insulin pump with Guardian sensor
- Age 18 to 80 years
- Hemoglobin A1c level less than or equal to 10%
- Not currently known to be pregnant, nor planning pregnancy during the study.
- Willingness to follow the protocol and sign the informed consent
Who cannot join
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Pregnant or lactating females
- Subject has Glycosylated hemoglobin (HbA1c)< 10 % at time of screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc contact
About this study
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.
Read more
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
- Being tested
- PIS
- Keywords
- Infusion sets, insulin pumps, AID system
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PISDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Amir Tirosh, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684561
- Sponsor's protocol ID
- Sheba-24-1530-AT-CTIL
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET
- ClinicalTrials.gov ID
- NCT06684561
- Acronym / sponsor ID
- Sheba-24-1530-AT-CTIL
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Infusion sets, insulin pumps, AID system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: PISAll 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMed™ 780G Insulin pump with Guardian sensor
- Age 18 to 80 years
- Hemoglobin A1c level less than or equal to 10%
- Not currently known to be pregnant, nor planning pregnancy during the study.
Key exclusion criteria (3 listed)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Pregnant or lactating females
- Subject has Glycosylated hemoglobin (HbA1c)< 10 % at time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PISAll 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 | Arm 1 |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc contact
Questions about this trial
What is this clinical trial studying?
A study testing PIS in people with Type 1 Diabetes Mellitus, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc (Maya.Laron-hirsh@sheba.gov.il, maya.laronhirsh@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.