Dive Brief:

• Clinical trial results for Insulet's Omnipod 5 automated insulin pump system showed improvements across multiple metrics after three months of use for adult, adolescent and pediatric patients with Type 1 diabetes. The trial compared patient usage of the inulin pump system with their standard therapy, either the use of another insulin pump or insulin injections.
• For the adult group, which includes adolescents, and the child group, trial results showed use of Omnipod 5 lowered blood sugar levels and increased time spent per day in desired blood sugar ranges. Insulet presented the trial results Saturday during the Endocrine Society's 2021 annual conference.
• Omnipod 5 is a wearable insulin pump that connects with continuous glucose monitors to help patients manage their diabetes. Insulet plans to launch Omnipod 5 in the first half of 2021 and has pointed to the pump as a key growth driver for the company going forward.

Dive Insight:

The diabetes tech space, which includes both insulin pumps and CGMs, has been gaining momentum in recent years. That growth has only accelerated during the coronavirus pandemic as patients stayed out of healthcare settings and embraced virtual care, such as wearables.

Recent surveys from SVB Leerink show that both insulin pump and CGM markets are expected to keep growing as patient use increases and new populations are further penetrated.

Wall Street analysts have been bullish on the space due to the market growth potential and new product launches expected in 2021, including Insulet's Omnipod 5.

Industry and analysts are also looking at the future of diabetes tech called closed-loop systems, where a CGM and insulin pump work automatically together to manage patient blood sugar levels.

The Omnipod 5 system will compete against Tandem Diabetes Corp., whose Control-IQ technology was the first FDA-cleared algorithm for use with a fully interoperable, automated insulin dosing system. Both pumps work with Dexcom's G6 CGM system.

A third closed-loop system is also planned from Medtronic, the MiniMed 780G pump system. The pump, which will work with a Medtronic CGM, is available in Europe but there is no set timeline for a U.S. launch.

J.P. Morgan analysts believe that Omnipod 5 is likely to be the market leader for closed-loop systems due to the device being cheaper than Tandem’s offering and features like being a tubeless wearable pump

One key data point form the Insulet's trial is the amount of time patients stayed in their desired daily blood sugar range. For adults and adolescent patients, time in range increased by 2.2 hours per day compared to their standard treatment. For children, time in range increased by 3.7 hours per day.

The trial results also showed a decrease of patients' HbA1c, a measurement of patient blood sugar levels over about a three-month period. The adult and adolescent patient group's average HbA1c improved from 7.16% to 6.78% compared to their standard treatment, and the children group's improved from an average HbA1c level of 7.67% to 6.99%.

Wall Street analysts said that the trial results were mostly in line with expectations but still strong.

"The adult data looks very good, but the pediatric data is fantastic, in our view, given how difficult that patient population is to treat," J.P. Morgan analysts wrote.

SVB Leerink said that the results are positive enough to suggest an FDA clearance for the device.

Insulet's trial had to be unexpectedly halted due to a software glitch in the pump. During the pause, patients were taken off the Omnipod 5 and used either another insulin pump or insulin injections with a CGM. The pause took patients off the closed-loop system.

William Blair analysts contend the pause actually provided interesting data, with results showing the benefits of the closed-loop system compared to patients using more standard treatment methods.

Blood sugar levels increased and time in range decreased for both patient groups when use of the Omnipod 5 pump was paused, according to trial results. The metrics improved to previous levels for both groups once patients began using the pump again and were back on the closed-loop system.

The trial data was from 240 patients with Type 1 diabetes — 128 adults and adolescents and 112 children — over the span of three months. The trial compared the results to a 14-day trial of their standard therapy before the usage of the pump began.

Omnipod 5 has a breakthrough device designation and is under review by the FDA for U.S. market clearance. Insulet has a limited launch of the pump planned for the first half of 2021.

Insulet is now studying the results of the pump in the Type 2 diabetes population.