Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
NCT ID: NCT02677454
Last Updated: 2016-11-15
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
56 participants
INTERVENTIONAL
2015-06-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Flash Glucose Monitor
Each patient with Type 1 diabetes will have a subcutaneous tissue FGM sensor inserted. The sensor will produce a maximum of 1440 tissue fluid glucose measurements per 24 hours and 20160 measurements during the 14 day study. The FGM data (Abbott Freestyle Libre) will be compared to the time-matched reference blood glucose measurements.
Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose 6 to 10 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study.
Flash Glucose Monitor
Interventions
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Flash Glucose Monitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult patients, age 18 or older and \< 75 years
3. Written informed consent -
Exclusion Criteria
2. Patients with severe cognitive dysfunction or other disease which makes FGM use difficult
3. History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
4. History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
5. Continous Glucose Monitor (CGM) or FGM usage in the last month
6. Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
\-
18 Years
74 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Marcus Lind, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
NU-Hospital Organization, Sweden
Locations
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NU-Hospital Group
Uddevalla, , Sweden
Countries
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Other Identifiers
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Libre
Identifier Type: -
Identifier Source: org_study_id