Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Not Applicable
Completed
- Conditions
- Type 1 Diabetes
- Interventions
- Device: DUO Extended Set
- Registration Number
- NCT04810780
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
The study will follow subjects for 28 days while using an DUO extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMedâ„¢ 670G or 640G 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1st arm DUO Extended Set Wearing the Duo infusion set for up to 1 month or up to 4 infusion set failures.
- Primary Outcome Measures
Name Time Method Primery Effectivness Endpoint 28 days Precent of catheters reaching 7- day without set failure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Medical Center
đŸ‡®đŸ‡±Tel-Hashomer, Israel