Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes.

A continuous glucose monitoring (CGM) system consisting of a wireless, subcutaneously implantable glucose sensor and a body-worn transmitter is described and clinical performance over a 28 day implant period in 12 type 1 diabetic patients is reported. The implantable sensor is constructed of a fluorescent, boronic-acid based glucose indicating polymer coated onto a miniaturized, polymer-encased optical detection system. The external transmitter wirelessly communicates with and powers the sensor and contains Bluetooth capability for interfacing with a Smartphone application. The accuracy of 19 implanted sensors were evaluated over 28 days during 6 in-clinic sessions by comparing the CGM glucose values to venous blood glucose measurements taken every 15 min. Mean absolute relative difference (MARD) for all sensors was 11.6 ± 0.7%, and Clarke error grid analysis showed that 99% of paired data points were in the combined A and B zones.

[1]  S. Wild,et al.  Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. , 2004, Diabetes care.

[2]  R. Ratner,et al.  Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: the National Health and Nutrition Examination Survey. , 2006, Diabetes care.

[3]  Shoji Takeuchi,et al.  Injectable hydrogel microbeads for fluorescence-based in vivo continuous glucose monitoring , 2010, Proceedings of the National Academy of Sciences.

[4]  Thomas Peyser,et al.  A new-generation continuous glucose monitoring system: improved accuracy and reliability compared with a previous-generation system. , 2013, Diabetes technology & therapeutics.

[5]  Peter Calhoun,et al.  Performance comparison of the medtronic sof-sensor and enlite glucose sensors in inpatient studies of individuals with type 1 diabetes. , 2013, Diabetes technology & therapeutics.

[6]  S. Shinkai,et al.  Boronic Acids in Saccharide Recognition , 2006 .

[7]  Hui Jiang,et al.  Increased in vivo stability and functional lifetime of an implantable glucose sensor through platinum catalysis. , 2013, Journal of biomedical materials research. Part A.

[8]  Ronald Brazg,et al.  FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart Algorithm, a 1-Hour Warm-up Time , 2011, Journal of diabetes science and technology.

[9]  D. Klonoff.  Benefits and Limitations of Self-Monitoring of Blood Glucose , 2007, Journal of diabetes science and technology.

[10]  Steven J. Russell,et al.  A Comparative Effectiveness Analysis of Three Continuous Glucose Monitors , 2013, Diabetes Care.

[11]  Timothy L. Routh,et al.  Function of an Implanted Tissue Glucose Sensor for More than 1 Year in Animals , 2010, Science Translational Medicine.

[12]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[13]  R. Beck,et al.  Challenges for outpatient closed loop studies: how to assess efficacy. , 2013, Diabetes technology & therapeutics.

[14]  M. Phillip,et al.  Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes , 2011, Diabetes Care.

[15]  Elizabeth Goyder,et al.  Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial , 2007, BMJ : British Medical Journal.

[16]  Barry H Ginsberg.  The Current Environment of CGM Technologies , 2007, Journal of diabetes science and technology.

[17]  Boris Kovatchev,et al.  Continuous Glucose Sensors: Continuing Questions about Clinical Accuracy , 2007, Journal of diabetes science and technology.