The US Food and Drug Administration (FDA) has approved the first interoperable
insulin dosing "controller" software that connects enabled insulin
pumps and continuous glucose monitors, adding a new step toward fully
automated insulin delivery.
The Tandem Diabetes Care Control-IQ Technology connects to an "alternate
controller-enabled" insulin pump, aka "ACE pump," and an
"integrated continuous glucose monitor," or "iCGM."
"This is the first such controller that can be used with other diabetes
devices that are also designed to be integrated into a customizable diabetes
management system for automated insulin delivery," according to an
FDA statement.
The agency noted that the authorization "paves the way for iCGMs and
ACE pumps to be used with an interoperable automated glycemic controller
as a complete automated insulin dosing (AID) system."
The FDA approved the t:Slim X2 as the first ACE pump in February 2019 and
the Dexcom G6 as the first iCGM in March 2018.
"This is fantastic news that the diabetes community has been eagerly
awaiting," diabetes technology expert
David T. Ahn, MD, program director of the
Mary and Dick Allen Diabetes Center at Hoag Hospital, Newport Beach, California, told
Medscape Medical News. "By pairing with the Dexcom G6, the Control IQ technology is the
first to offer automated insulin titration without fingersticks."
The approval was based in part on data from the International Closed Loop
trial of 168 patients with
type 1 diabetes. Published in the
New England Journal of Medicine in October 2019, the study showed that the Tandem t:slim X2 insulin pump
and the Dexcom G6 CGM with the Control-IQ technology resulted in approximately
2.6 more hours per day spent with blood glucose levels in the target range
of 70 to 180 mg/dL compared with the two separate noncommunicating devices,
with 13 fewer minutes per day spent with glucose levels below 70 mg/dL.
The technology adds a new step in the progression toward fully "closed-loop"
or "artificial pancreas" development. In addition to currently
available controller software capabilities that automatically adjust basal
insulin infusions to prevent high and low blood glucose levels (ie, the
Medtronic 670G), the Control-IQ technology also can deliver bolus doses
when glucose levels are predicted to exceed a predefined threshold.
According to Ahn, who has no financial relationships with Tandem or Dexcom,
"it is the first hybrid closed-loop algorithm to offer automated
correction boluses, which led to an impressive 100% retention of study
patients in their pivotal clinical trial."
And, he added, "Also unique to the Tandem, similar to an iPhone software
update introducing new features, the Control IQ feature will be available
via a free downloadable software update that can be applied to any Tandem
X2 pump, which has been the market for a couple years."
The FDA statement cautioned that although the system has been assessed
for reliability, "incorrect and inappropriate calculation, and command,
delay of insulin delivery can still occur.
"Other risks associated with use of the interoperable controller can
include incorrect insulin delivery as a result of loss of communication
between connected devices, or from exploitation of cybersecurity vulnerabilities,"
potentially leading to hypoglycemia or hyperglycemia, the FDA notes.
Nonetheless, Ahn said, "the approval as an ACE pump with compatibility
with iCGM is the formal introduction to a world of automated insulin delivery
where users can choose their preferred insulin pump and continuous glucose
monitoring system. Patients win with more options to choose from."
To view the original
Medscape Medical News article, please click
here.