Closed-loop insulin delivery shows promise in pregnancy
medwireNews: A small study suggests that closed-loop insulin delivery can produce equivalent glycemic control to that of sensor-augmented pump delivery, but with less hypoglycemia, during 1 month of use by pregnant women with type 1 diabetes.
Previous studies from the same research team tested closed-loop delivery, alone or compared with a sensor-augmented pump, for short periods in the setting of a research facility. In this latest trial, the 16 participating women were randomly assigned to use closed-loop delivery or a senor-augmented pump for 4 weeks, followed by a 1–2 week washout period and then 4 weeks using the alternative delivery system.
After the randomized period, the women were allowed to keep using any combination of the study devices through delivery and up to 6 weeks postpartum, and the researchers report that, “despite frequent device hassles,” such as needing to reset the closed-loop system, 75% of women opted to continue with the full closed-loop system for this period.
Eight of the women had used a pump prior to study enrolment, but just three had used continuous glucose monitoring (CGM). All received training in the study devices and 2–4 weeks of practice before randomization.
During the randomized phases of the trial, closed-loop delivery resulted in a slight increase in the time women spent within the pregnancy target blood glucose range of 63–140 mg/dL (3.5–7.8 mmol/L), at 62.3% versus 60.1% with sensor-augmented pump delivery.
This difference was not statistically significant, which the researchers suggest could be a result of the high level of control already achieved with the sensor-augmented pump, or the small number of patients enrolled. Also, they note that they enrolled a wide variety of women, including a night-shift worker, a woman who struggled to avoid post-exercise hypoglycemia, and three who rarely attended clinic appointments.
Overall, hypoglycemia was significantly reduced by closed-loop delivery, with the time spent below 63 mg/dL (3.5 mmol/L) reduced from 2.7% to 1.6% and that below 50 mg/dL (2.8 mmol/L) from 0.5% to 0.2%.
Helen Murphy (University of Cambridge, UK) and study co-authors note that the time spent within the standard blood glucose target range of 70–180 mg/dL (3.9–10.0 mmol/L) was around 72%, which was comparable to the 68% achieved by the CGM group of the CONCEPTT trial.
“Taken together, these data suggest that closed-loop insulin delivery facilitates good day-to-day glucose control in a broad patient population and is effective for minimizing the risk of hypoglycemia,” the team writes in Diabetes Care.
They add: “Larger trials of longer duration closed-loop insulin delivery are needed to understand the effect on maternal glucose control and infant health outcomes in routine care settings.”
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