Germany’s Emperra GmbH is preparing to launch the world’s first insulin pen, capable of wirelessly transmitting information on insulin injections to an external blood glucose management device. The ESYSTA BT pen using Bluetooth, is designed to be used in combination with a wireless blood glucose meter as a complete diabetes management system.

Both the ESYSTA portal and the ESYSTA app have received a CE mark for compliance certification. Emperra plans to use currently-available scientific data from diabetic patients in Germany to secure US Food and Drug Administration (FDA) approval later this year.

“The smart insulin pen and corresponding software appeal to patients and doctors who prefer state-of-the-art technical solutions and who have recognized that the digitalization of diabetes management is a simple and reliable solution,” said Dr. Christian Krey, CEO of Emperra GmbH. With a high level of data quality and security, the ESYSTA BT pen could help doctors telemedically adjust insulin levels for patients with both type 1 and type 2 diabetes.

The mobile ESYSTA app allows patients to keep a digital blood glucose diary, as well as relay treatment recommendations to the patient. The smart insulin pen is also subject to reimbursement as a medical device, by all statutory health insurers in Germany.

“We are proud that we can use all U-100 insulins in 3 ml cartridges with the development of specially customized adapters,” said Dr. Janko Schildt, Founder and Managing Director responsible for medicine and technology. “As a result, every insulin-dependent patient can be equipped with ESYSTA®, regardless of whether the insulin comes from Lilly, Sanofi or Novo Nordisk.

“Even the accidental mixing up of basal and bolus ESYSTA® pens and priming (deaeration) can be identified on the ESYSTA® portal,” Schildt continued. “In combination with real insulin application data, I believe as a doctor that this constitutes an evolutionary leap for the digital age of diabetes management.”

Diabetic patients often measure their blood glucose levels and inject insulin several times throughout the day, making accurate documentation of these events essential. By automating documentation and analysis, patients and physicians can work together towards better diabetes management.

“Often the patient’s entries are difficult to read or simply forgotten, analyzing the data is laborious and time-consuming,” said Dr. Klaus Kusterer, a diabetologist from Mannheim, Germany. “Digital data recording can make a huge contribution to improving diabetes management. The data is complete and unadulterated and the patient no longer has to remember to document their data at all.”

In a study conducted by Emperra, in collaboration with a health insurance company, the ESYSTA system was found to help patients reduce their glycated hemoglobin (HbA1c) – a measure used to assess the average blood glucose level over a period of time – by one percent, over a twelve month period. This finding was also associated with a decreased use of injectable insulin – a major cost factor for patients and payers.