NEW YORK (Reuters Health) – In preterm infants, continuous glucose monitoring (CGM) reduced prolonged or severe hyperglycemia and hypoglycemia in an international randomized controlled trial.
Both conditions “are associated with long-term harm,” Dr. Kathryn Beardsall of the University of Cambridge, UK, told Reuters Health by email. “Another recent paper has shown that the intervention is cost effective, which supports the use of CGM to become an established part of clinical care, not simply a valuable research tool.” (https://bit.ly/3pONP92)
“We have been working with the clinical team and the Addenbrooke’s Charity Trust to ensure that real-time CGM is now part of the standard of care for our extremely preterm babies,” she said. “Children and babies deserve technology that has been designed and tested appropriately for their use, not dependent on off-license use.”
As reported in The Lancet Child and Adolescent Health, the study was done in 13 neonatal intensive care units in the UK, Spain, and the Netherlands. Included infants were within 24 hours of birth, had a birthweight of no more than 1,200 grams (2.6 pounds), and a gestational age up to 33 weeks plus six days.
Infants were randomly assigned to real-time CGM or standard care (with masked CGM for comparison). The main efficacy outcome was the proportion of time the sensor glucose concentration was 2.6-10 mmol/L in the first week of life.
Safety outcomes were related to hypoglycemia (glucose concentrations <2.6 mmol/L), also in the first week of life.
Seventy infants randomized to real-time CGM and 85 receiving standard care were included in the primary analysis.
Compared with the standard care group, infants managed with CGM had more time in the 2.6-10 mmol/L glucose concentration target range (mean proportion of time, 94% vs 84%; adjusted mean difference 8.9%, equivalent to 13 hours).
More infants receiving standard care experienced at least one episode of a sensor glucose concentration <2.6 mmol/L for more than one hour (15% vs. 6%).
The authors state, “This study supports the clinical use of CGM in preterm infants to optimize nutritional delivery alongside improving glucose monitoring and management.”
Dr. Beardsall added, “We would encourage other centers to consider learning to use CGM, but acknowledge that these devices are not ideally designed for use in extremely preterm infants. Their use requires training and some experience, but we would consider it worth the investment… With this in mind, we are exploring the next steps in design solutions for these babies that we hope will encourage wider use.”
Dr. Jeffrey Loughead, Medical Director of the NICU and Pediatrics at Northwestern Medicine Central DuPage Hospital in Winfield, Illinois, commented in an email to Reuters Health, “This is a feasible concept. The equipment is readily available and likely easily calibrated to the newborn population, which has differing blood hemoglobin (quantitatively and qualitatively) than adults.”
“Use of CGM in target patient populations is intriguing,” he said. “Actually, term or near-term patients may be a better group – especially infants at high risk for hypoglycemia, such as infants of diabetic women, growth-restricted infants or markedly large for gestation infants. These infants are larger have more subcutaneous fat and often need frequent heel stick glucose measurements, (as many as 6-10 times in 24 hours), so a single subcutaneous sensor application would be preferable.”
“The very preterm infant is often receiving most of its nutrition as a continuous IV infusion, thus leading to a potentially more stable blood glucose,” he noted. “Term infants are being fed intermittently, so therefore have much wider swings in their nutritional resource and potentially their glucose.”
Dr. Luisa Gonzalez Ballesteros, Neonatal-Perinatal Medicine specialist and pediatric endocrinologist at Lenox Hill Hospital in New York City, also commented by email. “This approach is potentially beneficial as it facilitates tight glucose control,” she told Reuters Health. However, “at this time, there are no CGMs produced for very low birth weight (VLBW) infants specifically, which makes the manual insertion challenging.”
“Unfortunately, this technology will be limited in the developing world due to its cost and (lack of) availability,” she said.
“The advent of CGMs is exciting; however, it needs to be fine-tuned for the VLBW population to facilitate widespread use,” she concluded. “Until such time, it is important to continue stringent monitoring of these high-risk patients.”
SOURCES: https://bit.ly/3kgQR4K and https://bit.ly/2ZLmKcy The Lancet Child and Adolescent Health, online February 9, 2021.
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