Medtronic plc today announced the EnvisionTM Pro Continuous Glucose Monitoring (CGM) system — a fully disposable, zero calibration professional CGM system — has obtained CE (Conformité Européenne) Mark approval. Medtronic will begin commercial release in Europe and the Middle East this fall, subject to local regulatory requirements1. This new technology will empower healthcare professionals and their patients with either type 1 and type 2 diabetes to see accurate glucose levels and trends over time to develop more optimal diabetes therapy plans.
“Medtronic has a 20-year history in professional CGM as the first company to have an approved physician-use CGM system,” said Sheri Dodd, vice president and general manager for the Non-Intensive Diabetes Therapies business at Medtronic. “The launch of the Envision Pro CGM system represents multiple important innovations as the first disposable and zero calibration CGM from Medtronic.”
The glucose data collected by the Envision recorder generates up to five diagnostic reports that are reviewed by healthcare professionals with their patients. The main report, Pattern Snapshot, uses advanced pattern recognition algorithms to help advance the conversation between the healthcare provider and patient by identifying daily patterns of high and low sugar levels and their association with food, medication, exercise and sleep. With these insights, providers can facilitate therapy adjustments and provide lifestyle change recommendations to their patients in order to minimize excursions and the associated risk of complications. The Envision Pro CGM system provides accurate data that is blinded to the patient to obtain an unbiased view of their real-world glucose levels. It also has comprehensive event tracking features and easy-to-read reports, making it easier for physicians to have needed therapy discussions with their patients.
The Envision Pro system was designed with ease of use as a top priority. For instance, patients no longer need to calibrate the CGM through fingersticks. Also, there is no need to return the sensor or recorder to their physician, as both pieces are now fully disposable. The recorder communicates wirelessly with the patient’s smartphone allowing automatic data uploading so that the healthcare provider obtains the data seamlessly and can run reports remotely without additional in-office visits.
“Fingersticks and A1C only show part of how a person’s sugar levels are fluctuating throughout the day,” said Professor Dr. Christophe De Block, M.D., Ph.D., head of the Department of Endocrinolgy-Diabetology-Metabolism at Antwerp University Hospital. “The Envision Pro CGM system will allow me and my patients to see the percent of time that they are in the optimal target glucose range, and when they are high or low, so that we can better uncover how food, exercise and medication affect their sugar levels. This provides me the opportunity to have more informed discussions and to customize the diabetes management plans for my patients, and augments the personal engagement of patients thereby motivating them to adhere to therapeutic advice.”
1EnvisionTM Pro system is not approved for use in the U.S.