Feasibility of Continuous Long-Term Glucose Monitoring from a Subcutaneous Glucose Sensor in Humans
Abstract
The feasibility of continuous long-term glucose monitoring in humans has not yet been demonstrated. Enzyme-based electrochemical glucose sensors with telemetric output were subcutaneously implanted and evaluated in five human subjects with type I diabetes. Subject-worn radio-receiver data-loggers stored sensor outputs. Every 1-4 weeks the subject's glucose levels were manipulated through the full clinical range of interest using standard protocols. Reference blood glucose samples were obtained every 5-10 min and analyzed in our hospital clinical laboratory and/or on glucose meters. The sensor data were evaluated versus the reference data by linear least squares regression and by the Clarke Error Grid method. After surgical explantation and device inspection, the tissue-sensor interface was evaluated histologically. The remaining sensor-membranes were also recalibrated for comparison with preimplant performance. Four of the five glucose sensors tracked glucose in vivo. One sensor responded to manipulated glucose changes for 6.2 months with clinically useful performance (>/=90% of sensor glucose values within the A and B regions of the Clarke Error Grid). For this sensor, recalibration was required every 1-4 weeks. The other three transiently responding sensors had electronic problems associated with packaging failure. The remaining sensor never tracked glucose because of failure to form any sustained connection to adjacent subcutaneous tissue. Thus, stable, clinically useful sensor performance was demonstrated in one of five subjects with diabetes for a sustained interval of greater than 6 months. While this glucose sensor implant technology shows promise in humans, it needs to be made more reliable and robust with respect to device packaging and sensor-tissue connection.
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Long-term implanted glucose sensors in humans provided accurate readings while immobile, but posture changes led to erratic outputs.
“For example, Gilligan et al. found that long-term implanted glucose sensors in humans provided accurate sensor readings while immobile, but posture changes (i.e., standing and/or moving) led to erratic outputs.85”
From Biocompatible Materials for Continuous Glucose Monitoring Devices (2013) · cites this paper as [85]
Four of the five sensors failed to produce analytically useful data because of electronic failure or lack of integration into the surrounding tissue.
“However, four of the five sensors failed to produce analytically useful data due to either electronic failure or a lack of integration into the surrounding tissue.85”
From Biocompatible Materials for Continuous Glucose Monitoring Devices (2013) · cites this paper as [85]
After subcutaneous implantation in humans, one of five biosensors functioned for about 6 months, with at least 90% of measured glucose concentrations in the A and B regions of the Clarke Error Grid.
“Following subcutaneous implantation into humans, one of five biosensors functioned for ~6 months with ≥90% of all measured glucose concentrations falling within the A and B regions of the resulting Clarke Error Grid (i.e., clinically accurate and acceptable, respectively).”
From Biocompatible Materials for Continuous Glucose Monitoring Devices (2013) · cites this paper as [85]
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- Authors
- Gilligan, B. C., Shults, M., Rhodes, R. K., Jacobs, P. G., Brauker, J. H., Pintar, T. J., & Updike, S. J.
- Affiliations
- University of Wisconsin–Madison (US)
- Dexcom (United States) (US)
- ORCID
- Jacobs, Peter G.
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2004-06
- Volume
- 6
- Issue
- 3
- Pages
- 378-386
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- OpenAlex
- W2174424607
- Cited by
- 71
- References
- 15
- Citations by year
- 2026: 2 · 2025: 2 · 2023: 1 · 2022: 2 · 2021: 4 · 2019: 1 · 2018: 4 · 2017: 2 · 2016: 4 · 2015: 1 · 2014: 5 · 2013: 5 · 2012: 3
- FWCI
- 3.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Dexcom
- National Institutes of Health
- Topics
- Physical Sciences › Engineering › Electrical and Electronic Engineering › Electrochemical sensors and biosensors
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Chemical Engineering › Bioengineering › Analytical Chemistry and Sensors
- Keywords
- continuous glucose monitoring, subcutaneous glucose sensor, type 1 diabetes, sensor recalibration, Clarke error grid, sensor reliability, biomedical implants
- MeSH terms
- Adolescent, Adult, Blood Glucose, Calibration, Diabetes Mellitus, Type 1, Female, Glucose Tolerance Test, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Regression Analysis, Sensitivity and Specificity, Reproducibility of Results, Biosensing Techniques, Least-Squares Analysis, Monitoring, Ambulatory, Prostheses and Implants, Insulin Lispro
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