Diabeloop Announces Collaboration With Novo Nordisk to Pursue Its Interoperability Strategy With Connected Insulin Pens

A dedicated clinical program will assess the efficacy of the combined technologies

PARIS, FRANCE / ACCESSWIRE / March 21, 2023 / SFD 2023 - Diabeloop, a pioneer in Automated Insulin Delivery, will collaborate with leading global healthcare company, Novo Nordisk. The agreement covers integrating DBL-4pen™, Diabeloop's self-learning algorithm for MDI therapy, with Novo Nordisk's connected and reusable insulin pens, NovoPen^® 6 and NovoPen Echo^® Plus.

Diabeloop is planning a dedicated study for people living with Type 2 diabetes to evaluate the efficacy and clinical benefits of the combined technologies.

Diabeloop accelerates its interoperability strategy with connected pens

On the occasion of the annual congress of the Société francophone du diabète (SFD), in Montpellier, March 21-24, Diabeloop announces a collaboration with Novo Nordisk, a major global healthcare company.

The first milestone of the cooperation will focus on the integration of Novo Nordisk's new generation of connected pens, NovoPen^® 6 and NovoPen Echo^® Plus with DBL-4pen™.

DBL-4pen™ is a self-learning basal and bolus recommendation app for people with Type 1 and Type 2 diabetes who take multiple daily insulin injections (MDI). NovoPen^® 6 and NovoPen Echo^® Plus are connected pens with a dose memory function that keeps a history of the last 800 insulin injections and shows on a built-in digital display the number of units administered during the last injection, as well as the time since that injection. Data transfer from the connected pen to an external device is based on Near Field Communication (NFC). These connected pens are the only to be covered by public health insurance in France.

The common commitment of the two companies to bring innovative solutions for diabetes management to patients has driven the conclusion of this agreement.

"We are proud to be able to further expand our DBL-4pen™ interoperability strategy with this collaboration with Novo Nordisk. Our collaboration aims to bring more automated solutions to people with diabetes, optimizing their outcomes and improving their quality of life. With DBL-4pen™, we have developed an efficient self-learning algorithm for insulin dose recommendation, a significant step forward for MDI therapy, and we are excited to explore this with the innovative generation of NovoPen^® 6 and NovoPen Echo^® Plus connected insulin pens," explains Cécile Ferracci, CCO of Diabeloop.

Upcoming launch of a clinical program with Type 2 diabetes patients

The clinical program will start with an initial multi-brand, multicentric before/after 14-week clinical trial that aims to assess the efficacy and safety of DBL-4pen™ mobile application on glycemic control in patients with Type 2 diabetes. It will include forty (40) patients with T2D across four (4) hospitals in France.

Pr. Pierre-Yves Benhamou, Chief Medical Officer of Diabeloop, comments: "With this interventional, open, single-arm clinical trial involving adults with Type 2 diabetes, we aim to evaluate efficacy, safety and also treatment compliance. In addition, we will measure the improvement in quality of life and satisfaction of the enrolled patients and also evaluate the effect of DBL-4pen™ on the development of HbA1c in the extension phase."

Diabeloop will then initiate a dedicated clinical study, to assess the efficacy and the clinical benefits of the combined solution connecting DBL-4pen™ with NovoPen^® 6 and NovoPen Echo^® Plus connected pens. NovoPen^® 6 and NovoPen Echo^® Plus data will transmit to the DBL-4pen^TM self-learning algorithm which will recommend the dose of insulin to be injected in real-time from input data such as meals and exercise.

This trial program is shaping Diabeloop's future projects for MDI therapy. Diabeloop plans to address first the Type 2 population on intensive insulin treatment before soon expanding to people with Type 1 diabetes who do not have access to or desire to wear an insulin pump.

"We are delighted about this collaboration with Diabeloop - a company that has a shared ambition of bringing innovative digital health solutions to help people manage their diabetes," says Thomas Thestrup-Terp, Corporate Vice President, Digital Strategy and Solutions, Novo Nordisk. "Smart insulin pens offer digital connectivity for people living with diabetes and the potential to automatically recommend the ideal insulin dose in real-time. This could significantly improve the way diabetes medicines are used. We look forward to the data from the upcoming clinical study, to look at the potential benefits of NovoPen^® 6 and NovoPen Echo^® Plus alongside DBL-4pen™."

"Novo Nordisk France is pleased to support Diabeloop, a French company that has developed the first 'closed-loop' solution for patients treated with MDI. Novo Nordisk is thus supporting a game-changing company, in order to accelerate the CE marking of its new solution. We look forward to providing patients with a reliable solution that will take the NovoPen^® 6 and NovoPen Echo^® Plus from connected to smart reusable insulin pens," adds Christine Massien, Diabetes Medical Director within Novo Nordisk France.

DBL-4pen™, self-learning basal and bolus recommendation app for pen users

Diabeloop has developed a unique smartphone app that embeds its self-learning algorithm to dynamically titrate basal and bolus insulin doses. The app is connected to a connected insulin pen and a continuous glucose monitor (CGM).

This solution reaches a high level of personalization, taking into account both meals and physical activities, as well as glucose trends, and uses the entire patient history to fine-tune bolus amounts based on the patient's response to previous boluses. Requiring minimal input from users, DBL-4pen™ automatically recommends the ideal insulin dose in real time, which can be delivered via the pen with no more calculation to do.

"DBL-4pen™ can significantly contribute to improving clinical outcomes and reduce the huge mental burden for people living with Type 1 and type 2 diabetes. Diabeloop's mission and goal has always been to provide more solutions to people with diabetes. The combination of connected pens with Diabeloop's self-learning algorithm gives us the opportunity to offer more choice to the patients and bring the power of self-learning algorithms to more affordable and accessible pen solutions," concludes Erik Huneker, CEO of Diabeloop.

About Diabeloop

Diabeloop's mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.

Created in 2015, Diabeloop offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop's first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.

Diabeloop completed its Series C financing round in June 2022, securing 70 million euros, to accelerate its commercial roll-out, support its sustained growth strategy and its high-impact projects.

Today, Diabeloop gathers the personality, passion, and skills of talented individuals who work hard to improve the quality of life for every person living with diabetes.

Contact Information:

Stéphanie JÉGU
Global Brand & Communication Director, Diabeloop
stephanie.jegu@diabeloop.com

SOURCE: Diabeloop SA