PARIS, Sept. 16, 2021 /PRNewswire/ -- Diabeloop, created in 2015, deployed its first Automated Insulin Delivery (AID) system throughout Europe this year. The AI-based personalized solution is currently commercialized in Germany, the Netherlands, Italy, Spain and Switzerland, with more launches in EU countries coming soon. 

The interoperable controller, core of the comprehensive system, is currently available in combination  with Dexcom G6 CGM and Accu-Chek Insight insulin pump; and will be available with ViCentra's patch-like pump Kaleido.   

In parallel with the European commercial deployment, Erik Huneker and Marc Julien, co-CEOs of Diabeloop, announced they were working on the entry into the US market. The company has set-up a local and dedicated team to support future FDA applications.

The AACE CAP invitation is an honor and a great step towards introducing this innovative device to American patients. It will allow Diabeloop to increase access to key opinion leaders and strengthen relationships with other diabetes partners in the US.

"We are thrilled to welcome Diabeloop to our Corporate AACE Partnership (CAP) program," said Glenn Sebold, AACE Director of Relationships. "Our mission at AACE is elevating clinical endocrinology to improve global health, and our CAP program supports this by ensuring there is an open dialogue between industry and our association to advance patient care and find ways we can improve."

Marc Julien, Diabeloop co-CEO added: "We are very honored to join the AACE CAP. Diabeloop is dedicated to bringing individualized, easy to use diabetes management solutions to patients. Therefore, we strongly believe working with US based physicians, patient organizations and partners is key. We also have built a dedicated team, based locally to accurately understand the US market."

Diabeloop created its US Scientific Advisory Board

The US team quoted by Marc Julien is led by Zoe Heineman, Senior VP of North America, who has extensive commercial experience in the diabetes industry. She has a team of experts in regulatory, legal, and reimbursement supporting Diabeloop.

Diabeloop also has appointed several scientific advisors to its US Scientific Advisory Board: Drs. Nicholas Argento, Jason C. Baker, David M. Harlan, Camillo Ricordi and Paul Strumph.

Dr. Nicolas Argento, Medical Advisor to the diabetes program at Howard County General Hospital, is also a practiing endocrinologist at Maryland Endocrine. He has extensive experience in utilizing insulin pumps and continuous glucose monitoring (CGM), presented clinical research multiple times at major medical meetings and is very involved with the patient community via T1DExchange.

 "People with insulin requiring diabetes in the US are looking for more options to connect and combine their preferred iCGM with their preferred insulin delivery device. Physicians would like to be able to offer informed and enthusiastic support for use of a verified and certified integrated system. One size does not fit all. While some patients have integrated on their own with on-line DIY systems, most patients can't do so, and most physicians can't offer meaningful support of those freelance efforts. Diabeloop has advanced therapeutic machine learning available in a verified interoperable automated glycemic controller. I look forward to them bringing their solutions to the US, which will allow more patient choices", said Nicholas Argento, MD.

Dr. Jason C. Baker is a practicing endocrinologist at Weill Cornell Internal Medicine and Assistant Professor of Medicine at Cornell Medical College, NY. He also has an active interest in treating underserved populations which led him to found Marjorie's Fund.

"In order to successfully tackle the emotional and physical burden of type 1 diabetes, personalization of care is essential. The work of Diabeloop in bringing an individualized and accessible approach to diabetes care is an exciting, and essential, step toward helping people living with type 1 diabetes to thrive. Diabeloop strives to make its DBLG1 algorithm utilitarian and accessible, regardless of how technologically savvy a patient may be. I am thrilled to be joining Diabeloop as an advisor, and am excited to help shepherd the technology into the lives of more people living with diabetes".

Dr. David M. Harlan has led research focused on improving outcomes of those with diabetes for 35 years and currently serves as Co-Director of the University of Massachusetts Diabetes Center of Excellence and Professor of Medicine at the University of Massachusetts Medical School.    1999-2009 Dr. Harlan served as Chief of the Diabetes Branch of the NIDDK at NIH.

Dr. Camillo Ricordi is recognized as one of the world's leading scientists in diabetes cure-focused research and cell transplantation. He has served as Senior Associate Dean for Research and chaired the Dean's Research Cabinet at the UM Miller School of Medicine. He is the Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami, Florida, where he is Director of the Diabetes Research Institute and the Cell Transplant Program.

A double-board certified Pediatric and Adult Endocrinologist, Dr. Paul Strumph currently consults independently. He is a former Chief Medical Officer at Metavant, Lexicon and Senseonics and former JDRF Head of Scientific Research. Dr. Strumph is also a board member of the College Diabetes Network.

"I am excited to join Diabeloop as an advisor in order to help make the Diabeloop automated insulin delivery solutions (DBL-G1 and DBL-hu) available in the US to address the needs of people with diabetes and their physicians. By incorporating machine learning, these solutions are designed to improve clinical outcomes while reducing the burden for patients. Ease of implementation and use has been prioritized by interoperability with potentially any brand of alternate controller enabled (ACE) insulin pump and any brand of an approved icgm. A subset of people in the US with insulin dependent diabetes exhibit irreducible glycemic variability. These highly uncontrolled patients could benefit from the DBL-hu algorithm, with individualized long-term machine learning, developed by Diabeloop", declared Paul Strumph, MD.

Diabeloop Scientific US presentations, 2021 agenda

June:  ADA conference, two posters and 1 abstract were presented: 

1. "Insulin pump interoperability of Diabeloop DBLG1 System"
   A. Adenis, S. Pou, H. Romero-Ulgade, Y. Tourki, S. Franc, G. Charpentier, PY Benhamou, M. Doron, E. Huneker
2. "Daily Meal Size Variations do not affect glucose control in T1D adult patients under closed-loop equipped with DBLG1 System"
3. "Diabeloop DBL4K Hybrid Closed-Loop system improves time in range without increasing time in hypoglycemia in children aged 6-12 years."
   Dulanjalee Kariyawasam, Carole Morin, Kristina Casteels, Claire Le Talle, Cécile Godot, Annie Sfez, Nathalie Garrec, Michel Polak, Guillaume Charpentier, Sylvia Franc, Jacques Beltrand

Diabeloop participated as a sponsor of the recent Children with Diabetes "Friends for Life" conference for patients and families affected by type 1 in July, in Orlando, Florida.

Diabeloop also presented data at the Association of Diabetes Care and Education Specialists (ADCES) annual conference in August, 2021 regarding DBL-hu use for patients with type 1 diabetes and kidney disease.

Diabeloop is planning to present at the Diabetes Technology Society (DTS) meeting in November, 2021.

On Diabeloop's latest US developments, Zoe Heineman, Senior VP of North America, concluded: "Diabeloop is becoming known in the US for being able to do more for even the most complex cases of diabetes with personalized parameters available in our CE-marked interoperable icontroller, which runs self-learning insulin delivery algorithms using an iCGM and an ACE pump."

About Diabeloop

Diabeloop's mission: to relieve people living with Type 1 diabetes from 100+  therapeutic decisions and reduce their heavy mental burden. Initially conceived from a medical research project, Diabeloop was created in 2015 by Dr. Guillaume Charpentier, now Chief Medical Officer, and Erik Huneker who has co-managed the company with Marc Julien since 2016. This complementary management team works with experienced partners such as French technology research key-player CEA-Leti.

In 2018, DBLG1^® System, Diabeloop's first medical device for automated diabetes management, obtained CE marking, followed by DBL-hu, its solution for highly unstable Type 1 diabetes management in 2020.

A second round of financing of 31 million euros concluded in November 2019 to speed up the international commercial rollout of the DBLG1^® iController and support an ambitious R&D program.   Today, Diabeloop gathers the personality, the passion and the skills of over 100 talented individuals who work hard to improve the quality of life for every person living with diabetes.

DIabeloop's DBLG1 and DBL-hu are not FDA approved and not available for sale in the United States.

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SOURCE Diabeloop