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Cygnus GlucoWatch G2
Device Name:
GlucoWatch G2
Manufacturer:
Cygnus Inc., 400 Penobscot Drive, Redwood City, CA 94063, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Obsolete
Description:
The Cygnus GlucoWatch G2 is a wristwatch style automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the wrist. It is intended for self-measurement and home use. This device is now obsolete.
Assessment:
The technology used in the Cygnus GlucoWatch G2, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the GlucoWatch G2 biographer in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):791-800. doi: 10.1089/152091503322526996. PMID: 14633344. Available from: PMC2302793.

Ad Hoc protocol Children and adolescents with T1DM, aged 3.5 to 17.7 years (n=89) (Note: without interference)

Ad Hoc protocol Children and adolescents with T1DM, aged 3.5 to 17.7 years (n=89) (Note: during insulin-induced hypoglycaemia)

Ad Hoc protocol Children and adolescents with T1DM, aged 3.5 to 17.7 years (n=89) (Note: during meal-induced hyperglycaemia)

The authors concluded that, though the sensor accuracy was not as accurate as home BGMs, it may be sufficient for detecting trends.

Tansey MJ, Beck RW, Buckingham BA, Mauras N, Fiallo-Scharer R, Xing D, Killman C, Tamborlane WV, Ruedy KJ; Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: results from a diabetes research in children network (DirecNet) study. Diabetes Technol Ther. 2005 Feb;7(1):109-14. doi: 10.1089/dia.2005.7.109. PMID: 15738708. Available from: PMC2254760.

Ad Hoc protocol Children and adolescents with T1DM, aged 12.5±2.8 years (n=191)

The authors concluded that the modified sensor was more accurate than the original sensor and better for hyperglycemia than hypoglycemia.