LogoBiotechNW
The life science and biotech PR distribution service

EMPERRA's Bluetooth-enabled ESYSTA® Smart Insulin Pen and the ESYSTA® Smartphone App in the Last Stages of the CE Approval Process

Emperra logo new

Potsdam, Germany, 24 June 2015 / B3C newswire / -- Emperra GmbH E-Health Technologies, specialized in digital health systems and Tele-diabetology, today announced an important further development of the innovative, integrated telemonitoring product system ESYSTA® for insulin-dependent diabetes patients. The Bluetooth-enabled ESYSTA® Smart Insulin Pen, as well as the ESYSTA® diabetes smartphone app are almost ready for their market launch. The ESYSTA® smartphone app is also open for and compatible with other conventional Bluetooth-enabled blood glucose meters. Both components are in the last stages of the CE conformity assessment procedure and will be available as an extension of the ESYSTA® product system on the European market expectedly from late summer 2015.

Data transfer via Bluetooth. The prototype
EMPERRA® developed the ESYSTA® Bluetooth Pen for those diabetics, who would like to send their data directly from the ESYSTA® Insulin Pen to their smartphone. It is equipped with a Bluetooth interface via which it communicates with the also newly developed ESYSTA® App. Other Bluetooth enabled blood glucose meters can also be linked to the ESYSTA® app. Further connections, like sensors for continuous glucose measurement, are under development.  All data could be sent by the app to the clearly structured ESYSTA® portal. The insulin pen as well as the app are currently under the CE conformity assessment procedure and will be available all over Europe shortly.

On this topic, Dr. Christian Krey, CEO of EMPERRA®, comments: „The further development of the already commercially available insulin-data transferring ESYSTA Smartpen to a Bluetooth enabled insulin pen is a logical step. By the direct transfer of the insulin data to a smartphone, a database is available at all times, that will further simplify the treatment. First diabetes centers and health insurers have already expressed their interest in providing their patients with the  ESYSTA Bluetooth pen.“

The ESYSTA® Bluetooth transmission technology
While the well-known mechanical solution for injection and the tested magnetic sensory for dosage record was adopted from the current ESYSTA® Pen, the type of data transfer will be adapted to Bluetooth low energy standards. This basically enables the connection to Bluetooth enabled smartphones, computers and even wearables (like smartwatches and measuring instruments for vital signs). The dosing accuracy for insulin of all current manufacturers will furthermore be guaranteed by the ESYSTA® adapters. Well known features that make life with daily insulin injections easier, like the automatic date and time set up or the global data access to the ESYSTA® portal solution are of course integrated.
Moving towards highly modern high-tech diabetes management systems, the Potsdam-based medical technology think tank EMPERRA® takes the next big step. The development of a Bluetooth enabled insulin pen and the corresponding smartphone software will address patients, who prefer the latest technological solutions on mobile devices and would like to use the immediately available data for their self-management.

Dr. Krey says: „Emperra is planning to offer this integrated Bluetooth solution, in compliance with CE standards, as a medical device to the European market late summer and will thereby continue to be the main innovation driver especially for smart insulin pens and integrated diabetes solutions.”

The current ESYSTA® version, that already allows insulin data and blood glucose values to be transferred wirelessly and made visible for the patient and the physician, will still be provided to patients, who prefer easy solutions or are not willing or able to use devices like smartphones or computers. Especially in nursing homes or for elderly diabetics the already in use, short-wave based product system ESYSTA® has proved tremendous medical effects. ESYSTA® is already in use in Germany - on the patient's requirement or on the physicians recommendation by prescription. The costs are covered by the health insurances.

„ESYSTA, the first validated plug and play diabetes management system, that uses a transmitting insulin pen, which automatically transfers the data, is already available on the market and is reimbursed by health insurances. The addition of a Bluetooth-based insulin pen enables the expansion of the target group of type 1 and type 2 diabetics to those who would like to have mobile access to their insulin data.“, says Dr. Klaus Stöckemann, Peppermint Venture Partners and chairman of the Emperra advisory board.

The ESYSTA® app: the novelty
The ESYSTA® App, that can read data like date, time and injected amount of insulin, but also differentiate between injected insulin and insulin used for priming, is also suitable for Bluetooth blood glucose meters of other known manufacturers. The app will of course be able to transfer all generated therapy data automatically to the ESYSTA® portal, in order to have the complete range of the ESYSTA® portal services, like the simple representation of metabolic situations by a traffic light function, as well as clearly structured diagram profiles for blood glucose and insulin applications, to its disposal. Secure access by the attending physicians, the care staff or perhaps the relatives is integrated here. In order to offer a comprehensive therapy concept, the app is also aimed at acquiring manual data to complete the monitoring.

About the integrated diabetes tele-monitoring system ESYSTA®
With the ESYSTA® product system, EMPERRA® distributes the globally first GSM and web based insulin-integrated tele-monitoring product system. With the Bluetooth enabled addition to the product system, EMPERRA® expands the functionality of ESYSTA®.
The guiding principle of the development of ESYSTA®, in the first stage consisting of the wireless-based insulin pen, the mobile, wireless-based mini lab for blood glucose measurement and the internet data transfer base, is simple but path breaking. All data will be transmitted fully automatically and will be stored in an easy to understand, digital patient diary.
The patients neither need a download cable, nor special software, they do not even need to press a button.
The core component of the product system is the globally unique insulin pen, that can administer all marketable insulins of different manufacturers. Additionally, it completely transfers the insulin values with high system intelligence for further analysis of the treatment data to the ESYSTA® portal.
The currently used measuring methods require diabetics and nursing staff to manually transfer the insulin units, or complexly note them in their diabetes recordings. ESYSTA® provides an innovative and databank-based instrument, that offers completely new opportunities to  tele-diabetology.

Dr. Christian Krey comments: „An efficient instrument is given to the patients, that makes diabetes treatment significantly easier. Both the personal diabetes management as well as self-control of important vital signs. The patient's lifestyle is simplified and quality of life rises noticeably.“

Dr. med. Janko Schildt, Founder and General Manager responsible for medical science and technology says: „The use of ESYSTA® saves all users a considerable amount of time: this goes for the patient as well as their private and medical setting. With the existing and future further product developments, we are convinced to reach an even wider target group and to carry on supporting digital health care within reasonable costs in the patients'- physicians- and  nursing staffs' interest.“

The ESYSTA® hard- and software is completely CE certified therefore permitted in all EU countries. The ESYSTA® system fulfills all legal requirements for data protection and IT security. ESYSTA® can be prescribed via a simple prescription. The statutory as well as the private health insurances thereby cover the costs. 
With ESYSTA®, for the first time in the history of tele-diabetology, all for the diabetic relevant data is automatically recorded. Injected insulin doses, blood sugar levels and carbohydrate units are wirelessly and completely transmitted to a digital patient diary. All data can be traced back in context for months. A traffic light system signalizes critical daily values or conspicuous indicators to the patient and the attending physicians. Thus adjustments and rearrangements in therapy can be carried out quicker.

All relevant data is available on computers, tablets, smartphones (android/iOS) and for the first time also on Smart TV, via mobile network transmission and connection to an internet based analysis platform. This is not only useful to the patients, but also to the authorized physician and specialist, as well as the treating hospital and nursing staff.
ESYSTA® thereby simplifies the diagnosis, the application of the therapy and the patient care by physicians and qualified personnel. On this topic, Dr. Janko Schildt comments:„The product- and data management system ESYSTA® promotes in all its complexity the psychosocial and psychosomatic aspects in the life of the patients, that are important for every diabetes therapy. We have requested important soft indicators in our accompanying studies and could determine that the self-confidence of the ESYSTA ®users increased, as well as the growing self-responsibility.“
The expenses for the widespread, cost-intensive, chronical disease diabetes mellitus have been increasing for years. First studies suggest that these expenses could be cut demonstrably and considerably by using ESYSTA®.

Further details on the ESYSTA system can be found on: www.emperra.com

Emperra Esysta

For high resolution please click the image.

 
About EMPERRA®  E-Health Technologies

EMPERRA® was founded in 2008 in Potsdam and is defined by three clear missions:

  • The improvement of quality of life of patients and their relatives
  • Better patient care by supporting physicians and medical professionals
  • Discharge of payers in the healthcare sector

The company has taken the global endemic rise in diabetes mellitus, observable since the end of the 1990's, as an opportunity for the development of ESYSTA®. With the development of the innovative product system ESYSTA®, EMPERRA® managed to make an important contribution to the treatment of diabetes patients. Further technological innovations are under development. Furthermore, specialized consulting and management services in the telemonitoring sector are provided.

The company is integrated in a renowned network of universities, research institutions, medical and sociopolitical stakeholders and advisory bodies.

In 2015, EMPERRA® is focused on the forced market launch of ESYSTA®
Simultaneously with the market launch of ESYSTA, in the summer of 2013 a first comprehensive pilot project was started together with a large local German statutory health insurance on the basis of the specifications of the social security statute book (SGB) V, § 140 ff. The study was announced all over Europe and its results will be globally published after the presence of the final results.
During this pilot project, approximately 300 diabetes mellitus patients of type 1 as well as type 2 were provided with ESYSTA®.
The interim evaluation of the available metabolic parameters of the participants by more than 30 study-accompanying diabetologists already showed significant improvements, both in the available medical metadata as well as in the psychosomatic and psychosocial respect.
A rise in the patients self-confidence in the diabetes therapy can be determined as well as measurable self-learning effects, up to statements from the participants about their improved social integration.
Some of the accompanying diabetologists observe that thanks to the ESYSTA® data management, therapy adjustments, that without ESYSTA® would have taken a great deal of time to be recognized, came into use more rapidly.

 
Contact

Emperra GmbH E-Health Technologies
Christian Krey, PhD
CEO
This email address is being protected from spambots. You need JavaScript enabled to view it.

Cookies make it easier for us to provide you with our services. With the usage of our services you permit us to use cookies.
Ok