Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System.
BACKGROUND
The objective of the analysis was to compare detection of hypoglycemic episodes (glucose <70 mg/dL lasting >15 min) with the FreeStyle Navigator Continuous Glucose Monitoring System (FSN-CGM) (Abbott Diabetes Care, Alameda, CA) alarms to detection with traditional finger stick testing at an average frequency of eight tests per day.


METHODS
The performance of FSN-CGM alarms was evaluated in a clinic setting using 58 subjects with type 1 diabetes mellitus (T1DM) monitoring interstitial glucose concentration over a 5-day period compared to reference YSI measurements (instrument manufactured by YSI, Yellow Springs, OH) at 15-min intervals. Finger stick glucose testing was evaluated in the home environment with 91 subjects with TIDM monitoring with the blood glucose meter integrated into the FreeStyle Navigator (FSN-BG) over a 20-day period. The reference was FSN-CGM with results masked from the subjects. Blood glucose values <=85 mg/dL were considered the optimal treatment level to avoid or reverse hypoglycemia.


RESULTS
With a threshold alarm setting of 85 mg/dL, 90.6% of hypoglycemic episodes were detected within +/- 30 min by FSN-CGM in the clinic study. When the alarm was activated, YSI glucose was <= 85 mg/dL 77.2% of the time. In the home environment, the average FSN-BG testing frequency was 7.9 tests per day. Hypoglycemia was verified within +/- 30 min by FSN-BG measurements <= 85 mg/dL at a rate of 27.5%.


CONCLUSIONS
Even with a high rate of FSN-BG testing, hypoglycemia detected by FSN-CGM was verified by patients with T1DM very infrequently. A high rate of hypoglycemia detection with a moderate rate of unnecessary alarms can be attained using FSN-CGM.
McGarraugh
Geoffrey
G
Abbott Diabetes Care, Alameda, California, USA. geoff.mcgarraugh@abbott.com
Bergenstal
Richard
R
D000293:Adolescent; D000328:Adult; D015374:Biosensing Techniques; D001786:Blood Glucose / Q000032:analysis*; D015992:Body Mass Index; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000175:diagnosis* / Q000453:epidemiology*; D008297:Male; D018670:Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult
D001786:Blood Glucose