Tandem Diabetes Care, Inc. (TNDM – Free Report) recently announced that bolus insulin dosing on the t:slim X2 insulin pump utilizing the t:connect mobile app has been cleared by the FDA. With this approval, the t:connect mobile app becomes the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on iOS and Android operating systems.
The updated t:connect mobile app is intended to provide t:slim X2 insulin pump users with the ability to program and cancel bolus insulin requests using their compatible smartphones. This new feature will be offered in the United States for no additional cost to new t:slim X2 insulin pump customers and in-warranty customers. When released, it will be available through a remote software update for the t:slim X2 insulin pump and the updated t:connect mobile app.
The company plans to roll out the mobile bolus feature update in a series of limited launch groups during spring, closely followed by an expanded launch later in summer this year. The limited launch participants have already been selected.
Per management, giving a meal bolus is currently the most common reason behind a person interacting with their pump thanks to advancements in diabetes management with the Tandem Diabetes’ Control-IQ technology. Given this, using a smartphone app allows for a convenient and discrete solution to administer a meal bolus.
Features of t:connect Mobile App in Detail
The t:connect mobile app is a secure, user-friendly mobile application. When paired with a t:slim X2 insulin pump, the t:connect mobile app discreetly displays the user’s pump information on their smartphone. The mobile app displays the last 24 hours of glucose trends, pump status changes and insulin therapy data, including basal and bolus deliveries and suspensions of insulin delivery, in addition to the newly authorized bolus feature.
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The mobile app also displays pump alerts and alarms while securely uploading data into the cloud-based t:connect web application wirelessly. It is worth noting that the t:slim X2 insulin pump operates independently from the t:connect mobile app, thereby allowing a user to retain the freedom to view pump therapy data, program requests and cancel bolus insulin requests from their pump as well.
The t:connect mobile app is compatible with select versions of iOS and Android operating systems in the United States. The company verifies if each device and operating system combination works as intended to program and cancel a bolus from a smartphone to ensure compatibility.
Notable Developments in Insulin Delivery
In addition to the latest FDA clearance, in December 2019, Tandem Diabetes was the first to be designated as an interoperable automated glycemic controller with Control-IQ technology. In February 2019, the company was the first to receive an alternate controller-enabled infusion pump classification. In June 2018, the company’s insulin pump was the first to be designated as compatible with integrated continuous glucose monitoring devices.
Per a report published in PR Newswire, the global automated insulin delivery systems market is expected to see a CAGR of 6.0% by 2027. Factors such as the increasing incidence of diabetes, growing geriatric population, rising strategic initiatives and favorable reimbursement policies, among others, are expected to fuel market growth.
Given the market prospects, the recent FDA clearance of t:connect mobile app for initiating insulin delivery from a smartphone seems strategic.
Other Notable Developments
During the third quarter of 2021, Tandem Diabetes witnessed robust international demand for the t:slim X2 pump. International pump shipments surged 209% year over year to 11,262 pumps. The company believes that the surge in pump shipments resulted from continued adoption of the t:slim X2 technology by new and existing customers and more healthcare providers prescribing the t:slim X2.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 13.2% compared to the industry’s 11% fall.
Zacks Rank and Key Picks
Currently, Tandem Diabetes carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are Owens & Minor, Inc. (OMI – Free Report) , Charles River Laboratories International, Inc. (CRL – Free Report) and HealthEquity, Inc. (HQY – Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Owens & Minor has a long-term earnings growth rate of 23.6%. Owens & Minor’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 32.4%, on average.
Owens & Minor has outperformed the industry over the past year. OMI has gained 55.7% against an 18.5% industry decline in the said period.
Charles River has a long-term earnings growth rate of 14%. Charles River surpassed earnings estimates in the trailing four quarters, delivering a surprise of 10.6%, on average.
Charles River has gained 1.9% against the industry’s 59.3% drop over the past year.
HealthEquity has a long-term earnings growth rate of 16.5%. HealthEquity’s earnings surpassed estimates in the trailing four quarters, delivering an average surprise of 9.8%.
HealthEquity has declined 30.1% against the industry’s 59.3% slump over the past year.