Sep 14,2015

Dexcom G5® Mobile Continuous Glucose Monitoring System Receives CE Mark

The Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System has received CE Mark (Conformite Europeenne) and will be available in several European countries in the coming weeks. This new system from Dexcom will be introduced to healthcare professionals and diabetes association delegates at the European Association for the Study of Diabetes (EASD) conference in Stockholm.

REGULATORY CE MARK

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Oct 05,2015

Nemaura Medical Present Positive Interim Clinical Trial Results of its sugarBEAT® System

Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing the sugarBEAT® CGM System as a minimally invasive, wireless continuous glucose monitoring system, announced today that it has conducted a further interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients, and have determined a reduction in MARD from 18% to 11.8%. MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values; a lower MARD indicates higher accuracy.

CLINICAL STUDY

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Oct 13,2015

Nemaura Medical Announces Filing of Application for FDA Pre-Submission Program for sugarBEAT® System

Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless CGM (Continuous Glucose Monitoring) system known as sugarBEAT®, announced today that it has submitted an application under the FDA Pre-submission Program to confirm the Classification of their CGM for the US market.

PRODUCT

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Oct 28,2015

Senseonics Reports CGM Europe Pivotal Study Results

Senseonics, Incorporated, a privately held medical device company focused on the development and commercialization of the first fully implantable, long-term continuous glucose monitoring (CGM) system, announced it has met its primary effectiveness and safety endpoints of the interim phase of the PRECISE (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Study. Results from 44 subjects with diabetes demonstrated strong accuracy throughout the entire 90-day continuous wear period with a mean absolute relative difference (MARD) of 11.4% in the 75-400 mg/dL range when compared to YSI blood reference values. The mean absolute difference (MAD) in the <75 mg/dL range was 13.5 mg/dL. Eighty-four percent (84%) of the sensor values were within 20% of the YSI reference. There were no significant adverse events reported related to the Senseonics CGM system.

CLINICAL STUDY

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Dec 02,2015

Nemaura Medical Announces Joint Venture for European Launch of sugarBEAT® System

Nemaura Medical Inc., a medical device company developing a minimally invasive wireless continuous glucose monitoring system known as sugarBEAT, announced today that it has entered into an equal Joint Venture agreement with DBJ Jersey to market the sugarBEAT system in Europe. The company anticipates a launch in Europe during 2016, pending obtaining requisite product approvals, for which the operational aspects of the launch will be entirely managed by DBJ Jersey under the terms of the agreement, with product support from Nemaura Medical.

COLLABORATION PARTNERSHIP

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Apr 01,2014

Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents

The aim of the study is to explore the experiences of adolescents with type 1 diabetes mellitus (T1DM) and their parents taking part in an overnight closed loop study at home, using qualitative and quantitative research methods.Adolescents aged 12–18 years on insulin pump therapy were recruited to a pilot closed loop study in the home setting. Following training on the use of a study insulin pump and continuous glucose monitoring (CGM), participants were randomized to receive either real-time CGM combined with overnight closed loop or real-time CGM alone followed by the alternative treatment for an additional 21 days with a 2–3-week washout period in between study arms.

CLINICAL STUDY

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Jun 11,2014

Joslin Diabetes Center adds digital health division, partners with Dexcom

Boston-based Joslin Diabetes Center has created a new non-profit division, called Joslin Institute for Technology Translation (JITT), so that the healthcare organization can collaborate with companies currently developing tools for people with diabetes, according to a press release. The new division will work with physicians to design decision support tools for managing insulin and glucose tracking, partner with medical device and technology companies so that Joslin can push for the creation of digital health tools focused on diabetes, and develop educational programs that help healthcare professionals and patients adopt the new tools. Joslin's first partnership is with San Diego, California-based Dexcom, maker of continuous glucose monitoring systems for patients.

COLLABORATION PARTNERSHIP

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Jun 16,2014

iPhone-based artificial pancreas promising in outpatient tests

An artificial pancreas system -- consisting of a continuous glucose monitor, and insulin pump, and an iPhone 4s -- has been shown to improve glucose regulation in a simulated outpatient setting in both adults and adolescents with Type 1 diabetes, according to a new paper in the New England Journal of Medicine. The adult patients had their glucose in an acceptable range (between 70 and 180 mg per deciliter) 79 percent of the time when using the system, compared to 58 percent during the control period. For the adolescents the change was smaller but still improved -- 76 percent versus 65 percent.

CLINICAL STUDY

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Jun 13,2014

Dexcom's Forthcoming Mobile App Platform to Integrate Data from Insulet's OmniPod System

Insulet Corporation and Dexcom announced today their intention to enable Dexcom's mobile App platform, which is currently under development, to integrate data from Insulet's OmniPod System. This will be the first version of a mobile App that is capable of incorporating glucose and other diabetes-related data from patients' devices and displaying the integrated data via a smartphone App.

COLLABORATION PARTNERSHIP

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Jul 01,2014

Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit

Maintaining glucose in the target range, while avoiding hypoglycemia, is challenging in critically ill patients. The study investigated the performance and safety of Medtronic Sentrino, a newly developed continuous glucose management (CGM) system for critically ill adults.

CLINICAL STUDY

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