Aug 28,2017

Tandem Diabetes Care Announces FDA Approval and Launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.

REGULATORY FDA

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Aug 29,2017

Nemaura Develops Medical Grade SugarBEAT® Android App for Diabetes Management

Nemaura Medical Inc. (OTCQB: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today that it has completed development of a medical grade app prepared and verified in accordance with ISO13485 quality systems and the appropriate medical devices directives, and designed to be used with the sugarBEAT® device or with glucose meters and strips to display glucose levels on users android mobile devices.

PRODUCT

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Sep 07,2017

Fitbit, Dexcom team up to bring CGM data to Fitbit's new smartwatch

Good news for anyone who thought Fitbit's move toward the smartwatch market would be a move away from health: The wearable maker has just announced a partnership with Dexcom that will bring data from the company's continuous glucose monitor directly to the display of Fitbit's upcoming Ionic smartwatch.

COLLABORATION PARTNERSHIP

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Sep 22,2017

New Dexcom API lets third-party apps access users' glucose data

Continuous glucose monitoring company Dexcom, which already allows users to monitor their CGM data on their phones and Apple Watch, is now making some patient data available to third parties via an API.

PRODUCT

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Sep 27,2017

Abbott's Freestyle Libre system becomes first CGM to be FDA cleared for use without fingersticks

Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA.

REGULATORY FDA

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Sep 21,2017

Nemaura Announces Successful Interim Results for SugarBEAT® European Clinical Trials

This clinical trial programme consists of a total of 525 patient days, comprising 75 patients continuously wearing sugarBEAT® for up to 14 hours per day over 7 consecutive days in a combination of home and clinic settings. The trials are expected to determine safety, accuracy, precision and utility of sugarBEAT® as an adjunct to finger stick testing, and is expected to be completed over the next ten weeks.

PRODUCT

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Oct 18,2017

Insulet and Dexcom Partner to Offer Choices for Animas Users

Insulet Corporation is partnering with DexCom, Inc. to provide the Omnipod System and a $200 gift card from Dexcom which can be used towards the purchase of a Dexcom G5 Mobile CGM for qualified Animas insulin pump users.

COLLABORATION PARTNERSHIP

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Oct 24,2017

Tandem Diabetes Care to Provide All t:slim X2 Insulin Pump Features Approved in 2018 to Users at No Cost and Expands Existing Dexcom Welcome Offer for Animas Customers

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced that it will make any new features approved for the t:slim X2™ Insulin Pump by the U.S. Food and Drug Administration (FDA) in 2018 available to all in-warranty users at no cost through the Tandem Device Updater. Tandem and continuous glucose monitoring partner, Dexcom, Inc., also announced the extension of their existing joint welcome program for Animas customers from December 31, 2017 to March 31, 2018.

PRODUCT

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Dec 08,2017

Lilly begins Phase 1 study of automated insulin delivery system

Indianapolis-based pharmaceutical Eli Lilly and Company announced this week that the first Type 1 diabetes patient has been dosed in a feasibility study of the company’s investigational Automated Insulin Delivery (AID) system. The company’s hybrid closed-loop platform consists of an insulin pump with a dedicated controller for system inputs, a dosing algorithm, and a continuous glucose monitor (CGM).

CLINICAL STUDY

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Dec 01,2017

Impact of Ramadan fasting on glucose levels in women with gestational diabetes mellitus treated with diet alone or diet plus metformin: a continuous glucose monitoring study

Women with gestational diabetes mellitus (GDM) are categorized as at high risk for adverse events during Ramadan fasting. However, this is largely based on clinical opinion. In this study, some light is shed on what happens to glucose levels during Ramadan fasting. The conclusion of the study is that CGM data indicates that Ramadan fasting in women with GDM treated with diet alone or with diet plus metformin was associated with lower mean glucose levels and higher rates of hypoglycemia when compared with non-fasting glucose levels. Women with GDM should be advised against fasting during Ramadan until further data is available.

CLINICAL STUDY

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