FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

Dive Brief:

Patients using Insulet's Omnipod 5 automated insulin pump saw improved A1C levels, and their glucose readings remained in target ranges longer for participants transitioning from multiple daily injections of insulin in the device's pivotal study, data presented at the American Diabetes Association's annual meeting showed.
The data comes as Insulet hopes to receive FDA approval of the product and begin its rollout this year.
In a separate poster presentation at the ADA meeting, Medtronic researchers found that use of an insulin pump significantly reduced the need for inpatient and emergency room services among patients who require multiple daily injections of insulin.

Dive Insight:

Omnipod 5 has been highly anticipated for its potential to help shift more patients to insulin pump therapy. Insulet CEO Shacy Petrovic argues that more patients will be willing to use smaller wearable pumps with outcomes similar to traditional injection therapy than older pumps that have been more expensive and cumbersome to use.

Wall Street analysts have suggested 2021 could be pivotal for the diabetes technology industry, with almost every major manufacturer of continuous glucose monitoring devices and insulin pumps launching products this year.

Patients requiring multiple daily injections of insulin are a key diabetes subpopulation for Insulet as approximately 80% of the company's users are patients that inject insulin multiple times a day. Over the past five years, the company has doubled its patient population to hundreds of thousands of people, the CEO has said.

The subgroup analysis of Omnipod 5 followed a small group of children and adults using multiple daily injections as standard therapy. Patients used the hybrid closed loop system for three months at home. The results showed use of the hybrid closed loop system among children and adults improved time in target range and reduced A1C, compared with daily injections.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis in the subgroup.

Researchers said 97% of study participants chose to continue using the Omnipod system during an extension phase, suggesting high acceptability of the system.

SVB Leerink cited discussion with what the sales side analysts called a key opinion leader suggesting the expected FDA clearance to significantly boost Insulet's competitive position within insulin pump therapy, also noting Tandem Diabetes will face rivalry not only from Insulet but also Medtronic in the space

In Medtronic's presentation at the ADA meeting, the company's scientists presented a large set of healthcare claims data to compare diabetes-related and all-cause inpatient admissions and emergency room visits over a two-year period in individuals with type 1 diabetes who used pumps and patients who controlled their diabetes with multiple daily injections of insulin.

The study found that patients on pump therapy saw a 41% decrease in inpatient utilization, compared to a 3% increase for those using injections. Combining diabetes-related inpatient and ER utilization, individuals using insulin pumps saw a decrease of 34%, compared to a decrease of 8% for those using daily injections.

Individuals on insulin pump therapy also experienced a larger decrease in A1C, down 7%, compared to down 1% for injections, according to the data.