A Human Pilot Study of the Fluorescence Affinity Sensor for Continuous Glucose Monitoring in Diabetes

Autor: Ashok Gowda, Rafal Drabek, Arun P. Pillai, Ralph Dutt-Ballerstadt, Colton Evans, Eric Orzeck, Roger J. McNichols
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Blood Glucose
Male
Time Factors
Endocrinology
Diabetes and Metabolism
Pilot Projects
Type 2 diabetes
Biosensing Techniques
Bolus (medicine)
Materials Testing
Pain Measurement
Glucose tolerance test
medicine.diagnostic_test
Liter
Pain scale
Equipment Design
Fasting
Middle Aged
Texas
Anesthesia
Calibration
Original Article
Female
Adult
medicine.medical_specialty
Correlation coefficient
Transducers
Biomedical Engineering
Pain
Bioengineering
Predictive Value of Tests
Diabetes mellitus
Blood Glucose Self-Monitoring
Internal Medicine
medicine
Humans
Least-Squares Analysis
Aged
Retrospective Studies
business.industry
Reproducibility of Results
Glucose Tolerance Test
medicine.disease
Surgery
Diabetes Mellitus
Type 1
Diabetes Mellitus
Type 2
Luminescent Measurements
Linear Models
Feasibility Studies
business
Biomarkers
Popis: Objective: We report results of a pilot clinical study of a subcutaneous fluorescence affinity sensor (FAS) for continuous glucose monitoring conducted in people with type 1 and type 2 diabetes. The device was assessed based on performance, safety, and comfort level under acute conditions (4 h). Research Design and Methods: A second-generation FAS (BioTex Inc., Houston, TX) was subcutaneously implanted in the abdomens of 12 people with diabetes, and its acute performance to excursions in blood glucose was monitored over 4 h. After 30–60 min the subjects, who all had fasting blood glucose levels of less than 200 mg/dl, received a glucose bolus of 75 g/liter dextrose by oral administration. Capillary blood glucose samples were obtained from the finger tip. The FAS data were retrospectively evaluated by linear least squares regression analysis and by the Clarke error grid method. Comfort levels during insertion, operation, and sensor removal were scored by the subjects using an analog pain scale. Results: After retrospective calibration of 17 sensors implanted in 12 subjects, error grid analysis showed 97% of the paired values in zones A and B and 1.5% in zones C and D, respectively. The mean absolute relative error between sensor signal and capillary blood glucose was 13% [±15% standard deviation (SD), 100–350 mg/dl] with an average correlation coefficient of 0.84 (±0.24 SD). The actual average “warm-up” time for the FAS readings, at which highest correlation with glucose readings was determined, was 65 (±32 SD) min. Mean time lag was 4 (±5 SD) min during the initial operational hours. Pain levels during insertion and operation were modest. Conclusions: The in vivo performance of the FAS demonstrates feasibility of the fluorescence affinity technology to determine blood glucose excursions accurately and safely under acute dynamic conditions in humans with type 1 and type 2 diabetes. Specific engineering challenges to sensor and instrumentation robustness remain. Further studies will be required to validate its promising performance over longer implantation duration (5–7 days) in people with diabetes.
Databáze: OpenAIRE
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