First Interoperable Automated Glycemic Controller Approved for Use with Insulin Pumps

December 13, 2019 – The U.S. FDA has approved the t:slim X2TM insulin pump with Control-IQTM technology from Tandem Diabetes Care. Control-IQ is the first FDA-approved software in a new class of devices known as interoperable automated glycemic controllers that can help ensure proper insulin dosing.

Diabetes is a condition that interferes with the body’s ability to produce or use insulin. This can cause dangerous increases in blood glucose that can be fatal or lead to serious complications. For some patients, insulin pumps provide the best option for controlling blood glucose levels. The pumps are programmable devices that deliver insulin via subcutaneous infusion. There are two types of doses delivered – basal doses, which are small doses administered throughout the day, and boluses, which are doses delivered at mealtime. To ensure proper insulin dosing, insulin pumps must be be used in conjunction with glucose monitoring.

Control-IQ software automatically adjusts insulin delivery by connecting to an integrated continuous glucose monitor (iCGM) and a specific type of insulin pump known as an alternate controller-enabled insulin pump (ACE pump). Control-IQ uses data from the glucose monitor to proactively adapt a user’s insulin dosing to better meet their specific needs. This allows it to determine if a basal dose of insulin is required, and whether that dose should be lowered or increased.

In a clinical study, Control-IQ demonstrated its ability to determine and command safe and effective insulin delivery from a compatible ACE pump based on iCGM readings with limited user intervention outside of mealtimes. In addition, the FDA assessed Control-IQ’s reliability, cybersecurity, and fail-safe modes. The agency has advised that, while Control-IQ has been found to be reliable, it is still possible for incorrect or inappropriate calculations of insulin requirements to occur, as well as delays in insulin delivery. Other risks may include loss of communication between connected devices or exploitation of cybersecurity vulnerabilities that could lead to incorrect insulin delivery. These risks can lead to problems such as low blood glucose (hypoglycemia) or high blood glucose (hyperglycemia) that may require medical intervention.

Patients who already own and use an in-warranty t:slim X2 will have the option to add Control-IQ to their devices for free via a remote software download by the end of January 2020. New t:slim X2s with Control- IQ software already loaded are expected to begin shipping within the same timeframe, and will have a wholesale acquisition cost (WAC) of $9,995 per unit.