Medtronic plc, of Dublin, has gained CE-marking approval for its Minimed 780g system, a next-generation closed-loop insulin pump for people with type 1 diabetes between the ages of 7 and 80 years old. The advanced hybrid closed-loop system (AHCL) features an advanced autocorrection algorithm and Bluetooth connectivity.

The company plans to launch the Minimed 780G system this fall in select European countries.

The advanced Smartguard algorithm automates the delivery of both basal insulin and corrections to overcome a missed premeal insulin dose, known as a bolus, every five minutes to help diabetics avoid blood sugar highs and lows. The algorithm includes technology from Dreamed Diabetes Ltd., an Israeli company focused on optimizing insulin therapy for people with type 1 and type 2 diabetes.

Preliminary data from an early feasibility study of the AHCL system and Smartguard algorithm, presented earlier this year, showed that overall glycemia in the four hours following meals consumed without a bolus demonstrated 70.7% time in range and 3.26% time in hypoglycemia vs. 86% time in range and 7.65% time in hypoglycemia during consumed meals with a bolus.

When the Smartguard feature is turned off, the pump reverts to manual mode and users are simply provided an indication of when a fingerstick blood draw or blood glucose meter reading may be necessary.

Personalize goals, simplify use

Minimed 780G also lets users personalize and adjust their glucose targets with settings as low as 100 mg/dL, to maintain optimal blood sugar levels and improve glucose control.

“We wanted to design a system that further simplifies diabetes management and adapts to people’s life with the goal of enhancing their experience in a seamless way,” said Sean Salmon, executive vice president and head of Medtronic’s Diabetes Group.

Adding to the 780G’s ease of use is smartphone connectivity, which is new to the Minimed 700 series systems. Using Bluetooth, the Minimed Mobile app displays pump and continuous glucose monitoring (CGM) information and sends notifications to the user’s personal smartphone. The app “collects data from the pump and automatically sends this data to Carelink diabetes management software every five minutes when the Sync to Carelink feature is on,” a Medtronic spokesperson told BioWorld.

The Carelink Connect app gives health care providers and other care partners remote access to patient’s pump and CGM data, as well as notifications if the user’s blood sugar levels are out of the healthy range – a particular benefit with younger users. People who use the smartphone app can also opt to automatically upload their data to Carelink diabetes management software to support in-office and telehealth visits.

“We know it can be challenging to have to calculate carbohydrate intake before every snack or meal on a daily basis to ensure the right amount of insulin is dosed,” Salmon said. “With this system, users will have an extra layer of coverage for those times they miscalculate their carbs or forget to pre-bolus with an algorithm that automatically corrects for high glucose when needed.

Data to be presented at ADA

Data from three clinical trials that supported the CE certification will be presented at a Friday session of the virtual American Diabetes Association 2020 Scientific Sessions. Included in the roundup of results is the U.S. AHCL pivotal safety study. Investigators will also share results from FLAIR, a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored international, multisite, randomized crossover study of AHCL vs. the earlier version Minimed 760G, as well as a New Zealand-based AHCL randomized crossover study.

The 780G is one in a new line of Medtronic insulin pumps with Bluetooth smartphone connectivity. Also CE-marked are the Minimed 770G2 system, which comprises the same hybrid closed-loop technology as the 670G system, and the 770G3, which provides users with readings from a Medtronic glucose sensor without triggering an automatic insulin dose based on those readings. Rollout of those systems will depend on individual market approvals, the company said.

For the fourth quarter of fiscal 2020, Medtronic reported diabetes sales of $570 million, down 8.9% from $626 million in the same period the prior year. The decline was fueled by a delay in new patient starts on insulin pumps and the closing of physician offices due to COVID-19, as well as competitive pressures, Omar Ishak, Medtronic’s chairman and CEO, said on a Q4 earnings call. He added that the decline was offset in part by increased demand for diabetes supplies, including continuous glucose sensors and infusion sets, mainly in international markets.

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