EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

Launched by SHEBA MEDICAL CENTER · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new type of infusion set called the Photon Infusion Set (PIS) for people with Type 1 diabetes. The goal is to see how safe and effective these new infusion sets are when used with an insulin pump and continuous glucose monitoring system over a period of up to 10 days and 6 hours. Participants will change their infusion sets every 2-3 days and will wear the glucose monitor continuously to track their blood sugar levels. After trying the infusion sets, participants will have follow-up visits to share their data and experiences with the research team.

To be eligible for this study, participants must be between 18 and 80 years old, have been diagnosed with Type 1 diabetes for at least a year, and be using a specific insulin pump. They should also have a certain level of blood sugar control (measured by a test called hemoglobin A1c) and not be pregnant or planning to become pregnant during the study. Participants will need to commit to following the study rules and signing consent forms. This trial is not yet recruiting, but it aims to gather important information that could improve diabetes management for many people.

Gender

ALL

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.