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Improved Glucose Excursions Using an Implantable Real-Time Continuous Glucose Sensor in Adults With Type 1 Diabetes

¹ Department of Medicine and Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado
² Diabetes & Glandular Disease Research Associates, San Antonio, Texas
³ Department of Medicine, University of California, San Diego, California

Address correspondence and reprint requests to Satish K. Garg, MD, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, 4200 East 9th Ave., Campus Box B-140, Denver, CO 80262. E-mail: satish.garg{at}uchsc.edu

OBJECTIVE—The capability of emerging glucose sensor technology to continuously monitor glucose levels may provide ways to achieve glycemic targets while reducing hypoglycemia.

RESEARCH DESIGN AND METHODS—A first-generation, long-term continuous glucose sensor (DexCom, San Diego, CA) was implanted subcutaneously in 15 patients with type 1 diabetes. Safety, efficacy, and potential benefits were evaluated during a blinded control period and in a study period during which patients had real-time access to the glucose data.

RESULTS—The bias differences between self-monitored blood glucose (SMBG) and sensor data were <15% at 2.8, 4.4, 5.6, 8.3, and 11.1 mmol/l. No procedure or device-related adverse events were observed. Of 15 patients, 13 (87%) had functional sensors during the 12-h simulated home use study with 96% of points in the A and B regions of the Clarke error grid, an R value of 0.88, and a mean absolute relative difference of 16% when retrospectively compared with SMBG. In actual home use, during the blinded control period (50 ± 16 days) data were not displayed to the patient, whereas during the unblinded study period (44 ± 17 days) the data were presented to the patient, and alerts were set at 3.1, 5.6, and 11.1 mmol/l. Patients spent a median of 47% less time below 3.1 mmol/l (P < 0.05) and 25% less time above 13.3 mmol/l (P < 0.05) during the nonblinded study period compared with the blinded control period.

CONCLUSIONS—The availability of real-time continuous glucose values may help patients reduce their hyperglycemic excursions and lower the risk of hypoglycemia.

Abbreviations: DCCT, Diabetes Control and Complications Trial • MARD, mean absolute relative difference • SHU, simulated home use • SMBG, self-monitored blood glucose • YSI, Yellow Springs Instrument

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