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BACKGROUND: Continuous glucose monitoring (CGM), which enables real-time glucose display and trend information as well as real-time alarms, can improve glycemic control and quality of life in patients with diabetes mellitus. Previous reports have described strategies to extend the useable lifetime of a single sensor from 1-2 weeks to 28 days. The present multisite study describes the characterization of a sensing platform achieving 90 days of continuous use for a single, fully implanted sensor. METHOD: The Senseonics CGM system is composed of a long-term implantable glucose sensor and a wearable smart transmitter. Study subjects underwent subcutaneous implantation of sensors in the upper arm. Eight-hour clinic sessions were performed every 14 days, during which sensor glucose values were compared against venous blood lab reference measurements collected every 15 minutes using mean absolute relative differences (MARDs). RESULTS: All subjects (mean ± standard deviation age: 43.5 ± 11.0 years; with 10 sensors inserted in men and 14 in women) had type 1 diabetes mellitus. Most (22 of 24) sensors reported glucose values for the entire 90 days. The MARD value was 11.4 ± 2.7% (range, 8.1-19.5%) for reference glucose values between 40-400 mg/dl. There was no significant difference in MARD throughout the 90-day study (P = .31). No serious adverse events were noted. CONCLUSIONS: The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, is the first system that uses a single sensor for continuous display of accurate glucose values for 3 months.

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A new optical sensor suitable for practical measurement of sodium in serum and whole blood samples is described. The optical sensor is based on a novel PET (photoinduced electron transfer) fluoroionophore immobilized in a hydrophilic polymer layer. The design concept of the fluoroionophore follows the receptor-spacer-fluorophore approach to sensor design using intramolecular PET-based signal transduction. Key to the development of this sensor is the identification of a nitrogen-containing, sodium-binding ionophore, coupled with a fluorophore having the correct spectral and electron-accepting properties. The slope of the sensor is approximately 0.5%/mM in the typical clinically significant range of 120-160 mM. This sensor has been implemented into a disposable cartridge, used for a commercially available critical care analyzer (Roche OPTI CCA) with precision better than +/- 1 mM (1 SD). The sensor displays excellent stability against hydrolysis and oxidation, leading to slope changes <5% after 9 months wet storage at 30 degrees C. On the basis of this design concept, fluoroionophores for other cations such as potassium, calcium and magnesium can be prepared by substitution of the ionophore.

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This communication describes a new optical sensor suitable for practical measurement of extracellular (serum or whole blood) potassium. The sensor responds rapidly and reversibly to changes in potassium concentrations typical of whole blood samples. No interferences from clinical concentrations of calcium or pH are observed, and the sodium interference is very minor. Excitation and emission occur in the visible light region. This new potassium sensor is currently used in the Roche OPTI CCA, a commercially available whole blood analyzer.

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