FDA approves app to give doses of insulin

The Food and Drug Administration (FDA) has cleared the first-ever smartphone app that will assist in the delivery of mobile insulin to diabetic patients with iPhones and Androids.

Tandem Diabetes Care announced the FDA had approved it to deliver insulin with the assistance of its mobile app, called t:connect, in a news release on Thursday. The move is a major step toward improving direct care and using technology to help smooth the insulin delivery process to the estimated 37 million Americans with diabetes, Tandem says.

T:connect allows people using the company’s t:slim X2 insulin pump for insulin delivery “to program and cancel bolus insulin requests through the convenience of their compatible smartphone.”

John Sheridan, president and CEO of Tandem, said the FDA’s clearance “validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements.”

“With the improvements in diabetes management provided by Tandem’s Control-IQ technology, giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution,” Sheridan said in a statement.

The app, which is compatible with both iPhone and Android, pairs with the t:slim X2 insulin pump and delivers information to the smartphone, including glucose trends, pump status changes and insulin therapy data.

The news comes amid a larger fight to decrease insulin prices in the U.S., as the drug is one of the most expensive in the country.

The Centers for Disease Control and Prevention says that, in 2020, 1 in 10 Americans had diabetes and 88 million adults have pre-diabetes.

At the same time, average annual per capita insulin costs neared $6,000 in 2018 and average annual list prices for insulin rose 11 percent from 2001 to 2018, according to a 2020 report from the American Action Forum.

The American Action Forum said diabetes cost the U.S. $327 billion in 2017, “becoming the most expensive chronic disease in the nation.”

President Biden had included a measure in the Build Back Better Act to cap the price of insulin at $35 for those with private health care, individual insurance or Medicare, but the legislation has stalled in Congress.

Tandem said its app comes at no additional cost to customers, and it will roll out an update in the spring with a limited launch group.