Clinical evaluation of the GlucoWatch® biographer: a continual, non-invasive glucose monitor for patients with diabetes
Abstract
A device providing frequent, automatic, and non-invasive glucose measurements for persons with diabetes has been developed: the GlucoWatch biographer. This device extracts glucose through intact skin via reverse iontophoresis where it is detected by an amperometric biosensor. The biographer can provide glucose readings every 20 min for 12 h. The performance of this device was evaluated in two large clinical studies in a controlled clinical environment (n=231), and the home environment (n=124). Accuracy of the biographer was evaluated by comparing the automatic biographer readings to serial finger-stick blood glucose (BG) measurements. Biographer performance was comparable in both environments. Mean difference between biographer and finger-stick measurements was -0.01 and 0.26 mmol l(-1) for the clinical and home environments, respectively. The mean absolute value of the relative difference was 1.06 and 1.18 mmol l(-1) for the same studies. Correlation coefficient (r) between biographer and finger-stick measurements was 0.85 and 0.80 for the two studies. In both studies, over 94% of the biographer readings were in the clinically acceptable A+B region of the Clarke Error Grid. A slight positive bias is observed for the biographer readings at low BG levels. Biographer accuracy is relatively constant over all rates of BG changes, except when BG decreases more than 10 mmol l(-1) h(-1), which occurred for only 0.2% of points in the home environment study. Biographer precision, as measured by CV%, is approx. 10%. Skin irritation, characterized by erythema and edema, was either non-existent or mild in >90% of subjects and resolved in virtually all subjects without treatment in several days.
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The GlucoWatch Biographer was an FDA-approved device capable of non-invasive glucose monitoring over a 12 hour period with 6 measurements per hour.
“This US Food and Drug Administration (FDA)-approved device is capable of non-invasive glucose monitoring over a 12 hour period with 6 measurements per hour.”
From Wearable biosensors for healthcare monitoring (2019) · cites this paper as [30]
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- Authors
- Tierney, M. J., Tamada, J. A., Potts, R. O., Jovanovic, L., & Garg, S.
- Affiliations
- Cygnus (United States) (US)
- Sansum Medical Clinic (US)
- University of Colorado Health (US)
- Corresponding author
- Tierney, M.J.
- Venue
- Biosensors and Bioelectronics
- Publisher
- Elsevier BV
- Published
- 2001-12
- Volume
- 16
- Issue
- 9-12
- Pages
- 621-629
- ISSN
- 0956-5663 (ISSN-L)
- OpenAlex
- W2066037251
- Cited by
- 390
- References
- 20
- Citations by year
- 2026: 20 · 2025: 22 · 2024: 19 · 2023: 28 · 2022: 23 · 2021: 21 · 2020: 22 · 2019: 30 · 2018: 24 · 2017: 12 · 2016: 12 · 2015: 9 · 2014: 6 · 2013: 7 · 2012: 7
- FWCI
- 5.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biosensors and Bioelectronics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Electrical and Electronic Engineering › Electrochemical sensors and biosensors
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Keywords
- non-invasive glucose monitoring, diabetes mellitus, reverse iontophoresis, amperometric biosensor, Clarke error grid, skin irritation, home monitoring, continuous glucose monitoring
- MeSH terms
- Diabetes Mellitus, Equipment Design, Glucose, Humans, Iontophoresis, Skin, Blood Glucose Self-Monitoring
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