A Feasibility Study to Detect Neonatal Hypoglycemia in Infants of Diabetic Mothers Using Real-Time Continuous Glucose Monitoring.

Background: Infants born to mothers with diabetes commonly experience asymptomatic hypoglycemia after birth. Continuous glucose monitors (CGM) can detect asymptomatic hypoglycemia in this population without the need for painful glucose checks.

Methods: Infants born after 34 weeks of gestation to mothers with diabetes had a CGM placed after birth. One group of infants was remotely monitored in real-time by research staff during the hospitalization, whereas another group wore a blinded CGM. In both groups, hospital standard-of-care (SOC) glucose checks were performed. Clinical staff and families were blinded to CGM data. For CGM readings <45 mg/dL, research staff requested a verification blood glucose (BG) using the point-of-care glucometer.

Results: Sixteen infants were studied; 4 with a blinded CGM and 12 with remote monitoring (RM). When there were confirmatory hospital glucometer readings, the sensitivity of the CGM to detect hypoglycemia was 86% and the specificity was 91%. The positive predictive value was 55% and the negative predictive value was 98%. In the full cohort, hypoglycemia (<45 mg/dL) was confirmed in 12 of 16 infants with 30 events at <12 hours of life (HOL), 3 events between 12 and 24 HOL, and 1 event at >48 HOL. In the RM group, CGM detected hypoglycemia five times when the infant was not due for a BG check based on the SOC. Overall, the CGM detected five false-positive alerts and six true-positive alerts for hypoglycemia. Only one hypoglycemic episode was missed by CGM in the RM group. Barriers to recruitment included fear of pain with glucose checks, concerns with CGM use, satisfaction with the hospital SOC, personal reasons independent of the study, and lack of interest in participating in research.

Conclusions: Although there were barriers to recruitment and retention in the study, we conclude that CGM can provide added benefit for detecting hypoglycemia when used early after birth.