Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
NCT ID: NCT04810780
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2021-03-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1st arm
Wearing the Duo infusion set for up to 1 month or up to 4 infusion set failures.
DUO Extended Set
to evaluate saftey and efficacy of DUO extended set combined with glucose sensor
Interventions
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DUO Extended Set
to evaluate saftey and efficacy of DUO extended set combined with glucose sensor
Eligibility Criteria
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Inclusion Criteria
2. Using a MiniMed™ 670G or 640G 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
2. Pregnant or lactating females
3. Subject has Glycosylated hemoglobin (HbA1c) \> 10 % at time of screening.
18 Years
80 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof. Amir Tirosh
Director, Division of Endocrinology
Principal Investigators
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amir Tirosh, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Other Identifiers
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Sheba-20-7386-at-ctil
Identifier Type: -
Identifier Source: org_study_id
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