NEW YORK (Reuters Health) – Parental fear of hypoglycemia probably blunts the potential benefits of continuous glucose monitoring in children with type 1 diabetes, researchers conclude in a report published online December 30 in Diabetes Care.

“Overcoming the barriers that prevent the integration of these glucose data into day-to-day management of pediatric diabetes remains a substantial challenge,” the authors comment.

Dr. Nelly Mauras, at the Nemours Children’s Clinic in Jacksonville, Florida, and colleagues point out that continuous glucose monitoring (CGM) makes it possible to identify blood glucose patterns and variability in glucose excursions in people with type 1 diabetes.  This has been shown to improve glycemic control in adults, but to a lesser degree in children.

They note that CGM has not been studied extensively in young children, a group for whom diabetes management rests with the parents.  The team therefore conducted a 26-week study of 146 type-1 diabetics aged 4-9 years (mean 7.5 years) who were randomly assigned to CGM or to usual care, which included glucose readings at least 4 times a day.

Parents in both groups were instructed how to make insulin adjustments based on CGM or meter data and how to use computer software to review retrospective data to alter insulin dosing.

Mean HbA1c was 7.9% at randomization.  The primary objective was to reduce HbA1c by at least 0.5% without any episodes of severe hypoglycemia at 26 weeks.  Only 19% of the CGM group and 28% of the control group (p=0.17) met this target, the investigators report.

Episodes of severe hypoglycemia were not significantly different in the two arms, with 3 episodes in the CGM group and 6 in the control group, according to the report.

The authors found that the amount of time the CGM sensor was worn declined over the study period, with only 41% averaging at least 6 days per week of use at 6 months.

Discussing the results, they note that while the parents were generally well educated and had no major problems with the use of CGM, they did express concern about the accuracy of the sensor.  Another factor that may have led to the lack of substantial reduction in HbA1c was the insulin-adjusting algorithms used in this study, which were designed to mitigate the risk of hypoglycemia, Dr. Mauras and colleagues suggest.

Summing up, they conclude, “CGM in 4- to 9-year-olds did not improve glycemic control, despite a high degree of parental satisfaction with CGM. We postulate that this may be related to limited use of CGM glucose data in the day-to-day management of diabetes, target glucose levels that are too high, and a persistent, unremitting fear of hypoglycemia in the parents of these young children.”

SOURCE:

A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years

Diabetes Care 2011.