JMIR Publications

ABSTRACT

Background:

Real-time continuous glucose monitoring (rtCGM) systems have shown to be a low-pain, safe and effective method in preventing hypo- and hyperglycemia in people with diabetes of various age groups. Evidence on rtCGM use in infants, and in patients with conditions other than diabetes, remains limited.

Objective:

This case study describes the off-label use of rtCGM, and the use of an open-source app for glucose monitoring, in a newborn with prolonged hypoglycemia secondary to transient congenital hyperinsulinism during the perinatal period.

Methods:

rtCGM was introduced at 39 hours of age. CBG checks were performed regularly. In order to benefit from customizable alert settings and include hypoglycemic sensor glucose levels below 40 mg/dL, the open-source app xDrip+ was introduced at 9 days of age.

Results:

Time-in-Range (45-180 mg/dL) remained consistent above 90%, whereas Time-in-Hypoglycemia (<45 mg/dL) decreased, and mean glucose was maintained above 70 mg/dL at 72 h of life and after. Daily sensor glucose profiles showed cyclic fluctuations that were less pronounced over time.

Conclusions:

While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples for off-label uses of medical devices, rtCGM being a notable exception. Real-time information allowed us to better understand glycemic patterns and to improve the quality of glycemic control accordingly. Severe hypoglycemia was prevented, measurement of serum levels of insulin and further lab diagnostics were performed much faster, whilst the patient’s individual burden caused by invasive procedures has been reduced. A wider customizability of threshold and alert settings would be beneficial for user groups with glycemic instability other than people with diabetes, and hospitalized infants in particular. Further research in the field of personal and off-label open-source rtCGM use, differences between native and open-source algorithms in translating raw sensor data, as well as customization of commercially available rtCGM systems is needed. Clinical Trial: Does not apply.