Tag Archives: Hypoglycemia

Diabeloop presents the results of the use of its Automated Insulin Delivery (AID) over the past 12 months by 4,162 patients

PARIS, 21-Sep-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a leader in therapeutic AI applied to insulin delivery, reports today on 12 months of use of its hybrid closed-loop DBLG1 System on a large, multi-country patient cohort. While Time in Range (70-180 mg/dL) still shows constant improvement, time spent in hypoglycemia stays significantly low. Users share how these clinical results, combined with a growing trust in the algorithm has led to fewer interactions with the device and improved quality of life.

New data2: one year living with DBLG1 System
Cohort of over 4,000 patients in 5 European countries

The innovative company Diabeloop, which will be present this week at the EASD Annual Meeting 2022, shares new real-world data on its first Automated Insulin Delivery system use.

DBLG1 System reached the European market a little over a year ago with consistent utilization throughout this period, with merely 1% of users discontinuing use of the product3.

In line with previously presented data4, significant improvement in Time in Range is observed here on a much larger population. The cohort gathers 4,162 patients in five countries: Germany, Italy, Spain, The Netherlands and Switzerland. TIR gain is 17.6 percentage points over a year of real life use.

Pr. Pierre-Yves Benhamou, CMO and President of Diabeloop’s scientific committee and US advisory board, commented:

“When initiating a treatment with DBLG1, it can be expected that the recommended outcomes (i.e., a TIR>70%, a TBR<4% and a GMI< 7%) will be achieved in about half of patients. Currently in Europe, the rate of achievement with standard treatment is only 27%.”

Another significant result is that this improvement in time spent in the target range is combined with a still extremely low occurrence of hypoglycemia: 0.2% < 54 mg/dL, 1.1% < 70 mg/dL. For the patients’ clinical picture and for their overall quality of life, this means less than 20 minutes per day spent in hypoglycemia, whereas the maximum accepted in the international recommendations is 60 mins.

Andrea and Martin, users of DBLG1 System share the benefit they derived from DBLG1 System on their hypoglycemia:

“Before I started using the system, I always had restless nights, because I often got hypoglycemia at night. Now the nights are great, I have to say.”

“I feel safer knowing that I’m not going to start sweating at some point, somewhere, because I have a low. That always made me feel kind of weak. I used to work as a nurse in three shifts, so I wish DBLG1 had been available, because I didn’t really have a daily routine then, where DBLG1 would have supported me.”

Algorithm performance leads patients to entrust it with fuller meal management

In the current commercial version of DBLG1, thanks to the initial parameter (meal ratio) and intuitive food logging functionality, patients:

– have access to meal size pre-configurations (small – medium – large)
– can quickly declare their meal
– personalize the carb intake declaration.

Based on the declaration, the glucose trend at time of meal and incremental patient data, the algorithm will recommend the insulin dose to deliver and manage post-prandial time period.

Diabeloop has already announced it was working on new versions to allow optimal management without declaration. Testimonials and data5 of DBLG1 real-life use however tend to show that patients trust the currently available device’s performance enough to skip some meal declarations and/or to declare approximative carbs quantities, and still get satisfying results.

For example, for the three main daily meals (breakfast, lunch and dinner), the patients used the shortcut (small-medium-large) for half of the 45 million meals declared on DBLG1.

It has also been observed that the longer the patients use DBLG1, the less likely they tend to declare meals altogether and the system will regulate itself. On average, one less meal is declared per day after 6 months of use.

Throughout the first 12 months of commercialization, feedback from users has been tremendous, highlighting time-saving, mental load alleviation and overall quality of life improvement.

Eva shares:

“I would definitely say that the mental burden has become less, or that I have to put in less effort to get good values (…) My sleep in general has gotten much better. The blood sugar levels are much more stable. I remember when I would wake up at night or set my own alarm. That has become much better since I have the Diabeloop system. The nights are fantastic.”

Erik Huneker, co-founder and CEO of Diabeloop reacts to these new real-world data and users comments:

“There is nothing more fueling for us than seeing DBLG1 perform over many months while it contributes to people with diabetes various lifestyles and needs. We have now equipped 10,000 patients and look forward to providing more personalization, ever more simplicity of use and more choices…to more and more people with diabetes.”

DIABELOOP AT EASD, September 20-23:
Booth M06
Meet the Expert session, September 21, 10:00 – 10:30 am
Supporting patient empowerment and improving glycemic outcomes with connected pens and artificial intelligence – From DBLG1 to DBL-4pen.
Networking Hub – with Erik Huneker, Pr. Lutz Heinemann & Pr. Pierre-Yves Benhamou
Platinum sponsor of #dedoc voices program

SOURCE: EuropaWire

Pr. Pierre-Yves Benhamou: The outcomes observed in 1,000 patients using Diabeloop DBLG1 are, indeed, very good and encouraging

PARIS, 28-Sep-2021 — /EPR HEALTHCARE NEWS/ —

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.

SOURCE: EuropaWire