Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Blood Glucose, Blood Glucose Self-Monitoring
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes
- Adult patients, age 18 or older and < 75 years
- Written informed consent -
Exclusion Criteria:
- Pregnancy
- Patients with severe cognitive dysfunction or other disease which makes FGM use difficult
- History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
- History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
- Continous Glucose Monitor (CGM) or FGM usage in the last month
Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
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Sites / Locations
- NU-Hospital Group
Arms of the Study
Arm 1
Experimental
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.