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FDA Approves First Continuous Glucose Monitoring System with Fully Implantable Glucose Sensor & Compatible Mobile App
The U.S. Food and Drug Administration approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.
The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia). The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (e.g., smart phone or tablet) that is running a device-specific mobile app.
The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyzer. The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated during the clinical studies. During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent. The safety of this novel system will also be evaluated in a post-approval study. The FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system. In an 8 to 0 vote, the committee recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.
The FDA granted approval of the Eversense Continuous Glucose Monitoring System to Senseonics, Inc.
Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ technology
Tandem Diabetes Care®, Inc., a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, announced U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia). This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices. The Company plans to launch its new product with Dexcom G6® continuous glucose monitoring (CGM) integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA earlier this year. Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.
Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.
Medtronic and IBM Launch a Sweet New Diabetes App
Artificial intelligence continues to prove valuable across many healthcare specialties, but diabetes management really seems to stand out as an area where AI can truly make a direct impact on patient lives.
The latest example of the industry embracing AI’s capabilities for the millions of people living with diabetes is an app co-developed by Medtronic and IBM Watson Health dubbed the Sugar.IQ smart diabetes assistant. The app is designed to simplify and improve daily diabetes management by leveraging AI and analytic technologies from IBM Watson Health to continually analyze how an individual’s glucose level responds to their food intake, insulin dosages, daily routines, and other factors.
The idea is that the app will help people with diabetes uncover patterns that affect their glucose levels, which can help them make small adjustments throughout the day to stay on track.
For Further Information
More on the diabetes device market in the US can be found in a series of reports published by iData Research entitled the US Market Report Suite for Diabetes Devices . The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, insulin pens, insulin syringes and insulin pumps.
The iData report series on diabetes devices covers the US and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Diabetes Devices brochure and synopsis.