Issue 202 Item 5 Continuous Glucose Monitors Not Effective In Preventing Hypogly

GlucoWatch G2 Biographer (GW2B) and the continuous glucose monitoring system (CGMS) do not reliably detect hypoglycemia” in children and adolescents with type 1 diabetes. Detecting hypoglycemia is a “critically important” function of these FDA-approved devices, Dr. Eva Tsalikian and other members of the Diabetes Research in Children Network (DirecNet) Study Group note in the paper. Therefore, they assessed the performance of the two glucose monitors during both spontaneous and induced reductions in serum glucose.

During a 24-hour stay at a research center, 91 children age 3.5 to 17.7 years wore one or two CGMS devices and 89 of these subjects wore one or two GW2B devices. Data analysis centered on 192 GW2B and 401 CGMS reference pairs during hypoglycemia.

“Our results demonstrate that neither the GW2B nor the CGMS is accurate with respect to reporting glucose values in the hypoglycemic range,” the investigators report.

For example, when the GW2B alarm level was set at a reference glucose level of 60 mg/dL or lower, the sensitivity to detect hypoglycemia was low (23%) and the false-alarm rate was high (51%). For the original CGMS device as well as a modified CGMS device that became available in November 2002, the sensitivity to detect hypoglycemia was 36% and 49%, respectively, with a false-positive rate of 63% and 58%, respectively.

The accuracy of the GW2B and the CGMS is “considerably better” when reference glucose levels are set over 100 mg/dL, according to the team.

Dr. Tsalikian, from the Jaeb Center for Health Research in Tampa, said: “Both the CGMS and GW2B are not as accurate during hypoglycemia as during normal and high blood glucose levels. Both can be helpful in detecting trends and thus adjusting insulin doses accordingly and possibly improve HbA1c but not for serving as a sentinel for hypoglycemia.”

In an editorial, Dr. David C. Klonoff, from the Mills-Peninsula Health Services Diabetes Research Institute in San Mateo, California reminds clinicians that these two monitors are approved only as adjunctive devices.
When new devices come on the market, “their performance will need to be closely scrutinized, especially if their manufacturers should propose to market them as stand-alone monitors,” he writes.
Diabetes Care 2004;27:722-726,834-836.

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