Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
NCT ID: NCT04161651
Last Updated: 2019-11-20
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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UNKNOWN
NA
22 participants
INTERVENTIONAL
2019-11-30
2020-10-31
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
SUPPORTIVE_CARE
NONE
Study Groups
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single arm
eversense
eversense CGM
Interventions
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eversense
eversense CGM
Eligibility Criteria
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Inclusion Criteria
2. Age \> 18
3. Insulin treatment for at least 1 year (Either MDI of CSII)
4. HbA1c \< 11%
5. Signing informed consent and willing to apply with study procedure
Exclusion Criteria
2. History of DKA in the last 3 months
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
5. Any condition that require MRI imaging or planned MRI during the trial period
6. Known topical or local anaesthetic allergy
7. Known allergy to glucocorticoids
8. History of hepatitis B, hepatitis C or HIV
9. Any Bleeding disorder or taking anticoagulant medication
10. Participation in other clinical trial
11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
18 Years
ALL
No
Sponsors
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DYN Diagnostic LTD
UNKNOWN
Meir Medical Center
OTHER
Responsible Party
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Other Identifiers
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0047-19-COM
Identifier Type: -
Identifier Source: org_study_id
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