ArticleJournal of diabetes science and technology2012
A human pilot study of the fluorescence affinity sensor for continuous glucose monitoring in diabetes.
Article in Journal of diabetes science and technology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 17 citations in OpenAlex.
- First clinical evaluation of a new percutaneous optical fiber glucose sensor for continuous glucose monitoring in diabetes.Journal of diabetes science and technology · 2013Trial
- Blood glucose self-monitoring with a long-term subconjunctival glucose sensor.Journal of diabetes science and technology · 2013Trial
- Glucose biosensors based on Michael addition crosslinked poly(ethylene glycol) hydrogels with chemo-optical sensing microdomains.Journal of materials chemistry. B · 2023Article
- Generation of an immortalized mesenchymal stem cell line producing a secreted biosensor protein for glucose monitoring.PloS one · 2017Article
- High Affinity Mannotetraose as an Alternative to Dextran in ConA Based Fluorescent Affinity Glucose Assay Due to Improved FRET Efficiency.ACS sensors · 2016Article
- Thirty-fifth anniversary of the optical affinity sensor for glucose: a personal retrospective.Journal of diabetes science and technology · 2015Article
- Acute in vivo performance evaluation of the fluorescence affinity sensor in the intravascular and interstitial space in Swine.Journal of diabetes science and technology · 2013Article
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
objectiveWe 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
methodsA 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.
resultsAfter 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.
conclusionsThe 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.