Insulet, a prominent player in the diabetes care sector, is actively seeking to broaden the use of its Omnipod 5 insulin pump to include individuals with Type 2 diabetes after its recent regulatory submission to the U.S. Food and Drug Administration (FDA). The move could significantly impact the treatment landscape for the 30 million Americans currently living with Type 2 diabetes.
The Omnipod 5 device, which has been approved for use in Type 1 diabetes patients, is designed to automate insulin delivery, aiming to simplify daily diabetes management tasks. The intent behind expanding the device’s indication is to offer these same benefits to a broader patient population, specifically targeting those with Type 2 diabetes who are either on basal insulin therapy or multiple daily injections.
During the American Diabetes Association’s 84th Scientific Sessions, Insulet presented compelling study results for Omnipod 5’s use in Type 2 diabetes patients. Francisco Pasquel, the study chair and an associate professor of endocrinology at Emory School of Medicine, highlighted that the research demonstrated “substantial improvements in blood glucose outcomes and overall quality of life.” This included notable reductions in the participants’ mean HbA1c levels from 8.2% to 7.4%, an increase in the time spent within their target glucose range from 45% to 66%, and reductions in overall daily insulin dosages and times spent in hyperglycemia. These results also encompassed statistically and clinically meaningful enhancements in the management of diabetes distress among the study participants.
The phase of the study involved 305 individuals across 21 different sites, evaluating the effectiveness of the Omnipod 5 over a period of 13 weeks, post a 14-day standard therapy phase. The diversity of the study’s participants was also a significant focus, with about 24% being Black and 22% Hispanic, which is critical given the higher prevalence and increased mortality rates from Type 2 diabetes within these communities.
While automated insulin delivery systems have not yet received FDA clearance specifically for Type 2 diabetes, Insulet has made inroads with a basal-only insulin pump model called Omnipod Go, specifically cleared for Type 2 diabetes. However, unlike Omnipod 5, Omnipod Go does not feature connectivity with other devices.
Insulet’s current initiatives represent part of a broader trend within the diabetes technology sector towards expanding options for Type 2 diabetes management. Other companies, like Tandem Diabetes Care and manufacturers of continuous glucose monitors like Dexcom and Abbott, have also recently advanced their technologies to better serve this population. Notably, these companies have achieved FDA clearance for devices that cater to the needs of Type 2 diabetics who are not on insulin.
Despite Omnipod 5 not yet being approved for Type 2 diabetes, its usage in this population has been supported by prescribing practices and full reimbursement through the pharmacy channel, which does not differentiate between Type 1 and Type 2 diabetes prescriptions. This acceptance in clinical practice underscores the anticipated demand and potential for the device upon receiving the official label expansion, expected as soon as early 2025.
According to analysts like Robbie Marcus from J.P. Morgan and Margaret Kaczor Andrew from William Blair, the expanded labeling could drive significant market uptake. Marcus anticipates an acceleration driven by direct marketing efforts to sub-specialty practices beginning early next year, whereas Kaczor Andrew highlights the alignment of the study results with previous data, noting several metrics that surpass earlier studies.
All these developments signal a potentially transformative phase in the management of Type 2 diabetes, aiming to enhance patient outcomes through technologically advanced, user-friendly insulin management systems.
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