Status:
COMPLETED
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a MiniMed™ 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04810780
Start Date
March 1 2021
End Date
December 1 2021
Last Update
May 17 2022
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel