Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1

• EASD 2021 – Diabeloop, a pioneer in therapeutic artificial intelligence for diabetes management, is presenting new real-world data(1) of its Automated Insulin Delivery system, DBLG1. The personalized device fine-tunes insulin delivery using a state-of-the-art algorithm.
• Thousands of European patients have already been equipped since April 2021, with more countries to follow in the coming months.

(PRESS RELEASE) PARIS, 28-Sep-2021 — /EuropaWire/ —

Real-life data confirm clinical and pre-launch data: TIR significantly improved

Today, Diabeloop presents data¹ from a 1,000 patients equipped with DBLG1 System with Accu-Chek Insight insulin pump in Germany. One of the main insights unveiled is an overall Time in optimal glucose Range (70-180 mg/dL) of 73.4% for the whole cohort of patients.

When looking specifically at data² from patients whose HbA1c was available at initiation, it can be observed that Time In Range improved 17.1 percentage points. This result is consistent with results which have been previously published pre-launch³ showing an increase in Time In Range of 16.7 percentage points.

Hypoglycemia reduction a huge factor for an improved quality of life

Data also showed a significant reduction of time spent in hypoglycemia with Time below 70 mg/dL at 1% while time below 54 mg/dL was 0.2%. This outcome surpasses the targets of the 2019 International Consensus.

Feedback of people with diabetes and their caregivers have shown that reducing hypoglycemia is very important. In addition to the life-threatening risks associated with hypoglycemia, discomfort and a decreased quality of life weighs heavily on people experiencing it regularly.

Pre-launch patients
“It (diabetes) had a big impact on my professional life (…) because of my hypoglycemia.”
“I have almost eliminated lows (…), especially at night, which is important!”

Pr. Pierre-Yves Benhamou commented: “The 2019 International Consensus on Time in Range aimed at achieving >70% in range 70-180 mg/dL, <4% below 70 mg/dL and <1% below 54 mg/dL in the majority of people with type 1 diabetes. This means over 16 hours in target range and less than 1 hour below range. The outcomes observed in 1,000 patients using DBLG1 are, indeed, very good and encouraging.”

Patient satisfaction is high

In the 5 countries where DBLG1 System is currently available, feedback from equipped patients has been very positive about its impact on TIR and hypoglycemia, in addition to the system’s ease of use and enhancement of quality of life.

Public social media posts:
“87% TIR, no hypos”
“The result (related to sport): quite conservative but great. No hypo.”
“Very intuitive, little information needed to provide at initiation.”
“I am absolutely delighted. Sometimes I even forget that I have diabetes.
I let it (DBLG1) do the math and success shows.”

Erik Huneker, founder and co-CEO of Diabeloop, who will be presenting the data at EASD⁴ declared: “Looking at the great results and listening to patient feedback on real-life experiences with our system has been a great reward for our work, and encourages us to make the system even better going forward. We will be able to bring DBGL1 quickly to many more patients in Europe while we keep working on bringing more choices, more interoperability, and more solutions to people with diabetes”.

About Diabeloop
Created in 2015, Diabeloop is a high-growth company that 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.

A second round of financing of 31 million euros, concluded at the end of 2019, supported the international commercial rollout of the DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of more than 100 talented individuals who work hard to improve the quality of life for every person living with insulin-dependent diabetes.

About DBLG1
DBLG1 is a self-learning algorithm that automates and personalizes the treatment of Type 1 diabetes. The therapeutic artificial intelligence contributes to reducing the heavy mental burden associated with this chronic condition. Hosted on a dedicated handset, it is connected to a continuous glucose monitor (CGM) and an insulin pump. It analyzes the data in real time, and decides whether to maintain current settings, adjust or stop basal insulin delivery to avoid a predicted low/high or deliver a bolus to correct a high.

YourLoops, Diabeloop’s data visualization platform allows patients to access data generated by DBLG1 and share them with his/hers healthcare team.

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(1) Real-life internal data (YourLoops data extract, September 3 2021): 998 patients from Germany, who gave consent, equipped with DBLG1 System with Accu-Chek Insight insulin pump.
(2) Data from 152 patients equipped with DBLG1 System with Accu-Chek Insight insulin pump in Germany from April to September 2021 with available HbA1c at initiation, based on [Beck and al. 2019] equation for hb1Ac <=9% and hb1Ac>=6%”
(3) C. Amadou et al., Diabetes Care 2021 Jan; dc201809. doi:org/10.2337-dc20-1809
(4) Diabeloop’s Meet the Expert: DBLG1, key learnings 6 months post-launch, real-life use within an international environment
Tuesday, 28 September 19:30 – 20:00 CEST

DBLG1 System with the Accu-Chek Insight insulin pump from Roche is a CE-marked class IIb medical device for the treatment of type 1 diabetes for adults 18 years and older. CE certificate issued by TÜV Rheinland. This prescription device is intended for use by a patient. Diabeloop and DBLG1 are registered trademarks or trademarks of Diabeloop in Europe and other countries. ACCU-CHEK, ACCU-CHEK INSIGHT are trademarks of Roche /Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. in the United States and/or other countries./ The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Diabeloop is under license.

Media contact:

Stéphanie JEGU
stephanie.jegu@diabeloop.com

Logo:

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