medwireNews: The Tandem Control-IQ system delivers improved glucose control versus standard care in children with type 1 diabetes aged between 2 and 6 years and can be initiated virtually, report researchers.
Marc Breton (University of Virginia Center for Diabetes Technology, Charlottesville, USA) and co-investigator gave the families of the 102 trial participants the option of having virtual appointments using video conferencing or in-person clinic visits.
The vast majority chose the virtual option, with 81% of families randomly assigned to the closed-loop group receiving virtual training and more than 90% of all trial visits conducted online, reports the team in The New England Journal of Medicine.
The successful virtual initiation of closed-loop insulin delivery “is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable Internet access,” say the researchers.
All except five children used the closed-loop system for the full 13-week trial period, with four of the five remaining in the study. Two children refused to wear the pump after their families had received training and the other three stopped later in the trial, in one case because the child had pushed buttons on the pump, resulting in insulin delivery and hypoglycemia.
During the 13-week trial, the average time in target range (70–180 mg/dL; 3.9–10 mmol/L) increased from 56.7% to 69.3% in the 68 children in the closed-loop group.
The 34 children in the standard care group used the same continuous glucose monitor (Dexcom G6) as those in the closed-loop system along with either their personal insulin pump or multiple daily injections. Their average time in range improved only slightly from 54.9% to 55.9%, amounting to a 12.4 percentage point difference in favor of closed-loop control.
The difference was due mainly to a large reduction in the time spent in hyperglycemia among children in the closed-loop group. For example, the average time spent with levels above 250 mg/dL (13.9 mmol/L) was 8.4% versus 15.0% in the standard care group. This was not associated with an increased time in hypoglycemia.
The largest gains in glycemic control occurred overnight, with average time in range being 74% in the closed-loop group versus 56% in the standard care group, with the maximum difference seen at around 05:00 hours.
By week 13, 48% of the children in the closed-loop group met the glycated hemoglobin target of less than 7% (53 mmol/mol), compared with 30% of those receiving standard care.
In a linked editorial, Daniela Bruttomesso (University of Padua, Italy) writes that “[a] virtual approach has several advantages over in-person visits, including a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
But she stresses that factors such as patient preference, any legal issues, and access to technology must also be taken into account.
“A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children,” concludes Bruttomesso.
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N Engl J Med 2023; 388: 991–1001
N Engl J Med 2023; 388: 1052–1054