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Sensor-based glucose monitoring system accurate, safe in children with type 1 diabetes
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In children with type 1 diabetes, an alternative sensor-based glucose monitoring system accurately measured blood glucose levels, with most incidents of hypoglycemia or hyperglycemia detected, recent study findings show.
“The system is unique among [interstitial fluid] glucose monitoring sensors in that it can be worn for up to 14 days and does not require user calibration,” Julie Edge, MD, MBChB, FRCPCH, a consultant in pediatric diabetes at Oxford Children’s Hospital, and colleagues wrote. “Comparison of accuracy data from this study to that from other pediatric studies using [interstitial fluid] glucose sensors demonstrated that the factory-calibrated system provided similar accuracy to systems requiring daily finger-prick calibrations. The lack of user calibration eliminates potential variations in sensor systems that may be introduced through errors in [blood glucose] results used for calibration, calibration at inappropriate times (during rapidly changing glucose), missing calibrations or use of sensor rather than [blood glucose] values for calibration.”
Edge and colleagues analyzed data from 89 children with type 1 diabetes currently testing blood glucose at least two times per day and not using a continuous glucose monitor, enrolled across nine centers in the United Kingdom (mean age, 10 years; 50.6% boys; 56% using pump therapy; 44% on multiple daily injections). Children wore the sensor-based system (Free Style Libre Flash, Abbott Diabetes Care) for 14 days and were asked to perform capillary blood glucose tests daily, followed by an interstitial fluid glucose sensor measurement. Researchers compared sensor glucose measurements with capillary blood glucose measurements; participants were masked to results.
Overall mean absolute relative difference was 13.9%; absolute relative difference was 10.4%; mean relative difference was 1.7%. Consensus error grid analysis demonstrated 83.8% of results in zone A and 99.4% of results in zones A and B. Age, body weight, sex, method of insulin administration or time of use (day vs. night) did not affect accuracy.
Children remained in the target glucose range (3.9-10 mmol/L) at least 50% of the time (mean, 12.1 hours per day), with an average of 2.2 hours per day and 9.5 hours per day in either hypoglycemia and hyperglycemia, respectively, according to researchers. Most children or their caregivers responded favorably to questions regarding device wear, ease of use and comparison with self-monitoring blood glucose. There were four mild and one moderate device-related adverse events reported, including allergic reaction, blister, scabbing and abrasion on sensor removal.
“This study has confirmed that sensor accuracy is robust to patient characteristics such as age, body weight, method of insulin administration and sex,” the researchers wrote. “Accuracy of the system, along with its robustness to differing patient characteristics, are sufficient to recommend its use to pediatric patients as support in optimizing their glycemic control.” – by Regina Schaffer
Disclosure: Abbott Diabetes Care funded this study. All researchers’ institutions received financial support from Abbott Diabetes Care to conduct the trial.
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