What You Should Know:

–              Intuity Medical, Inc., a medical technology company committed to making it easier to live with diabetes, announced today that its POGO Automatic® Blood Glucose Monitoring (ABGM) system, featuring one-step testing, is now covered by Medicare Part B. This decision expands access to the innovative monitor for the 16.5 million seniors age 65 and up living with diabetes.

–              The Centers for Medicare and Medicaid Services (CMS) created two new coverage codes specifically for POGO Automatic, recognizing this new and significantly different technology compared to traditional blood glucose meters (BGMs). POGO Automatic features an all-in-one design that integrates testing supplies into a 10-test cartridge.

Advancing Diabetes Management: POGO Automatic Blood Glucose Monitoring System

POGO Automatic, the pioneering and sole FDA-cleared automatic blood glucose monitoring (ABGM) system available, revolutionizes diabetes management. It enables people with diabetes (PWD) to effortlessly test their glucose levels without disrupting their daily routines. This one-step process automates the multi-step glucose monitoring associated with traditional BGMs, particularly aiding seniors in checking their blood glucose more easily.

Endorsed as the optimal solution for numerous diabetes patients by Rosemarie Lajara, MD, an endocrinologist at Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas, POGO Automatic is recognized by healthcare professionals for its user-friendly design, which can enhance testing compliance. Dr. Lajara emphasizes the significance of such innovation for diabetes patients, especially within the Medicare population, which often includes individuals facing dexterity, visual, or physical challenges hindering traditional self-monitoring blood glucose (SMBG) meters.

Automating blood glucose testing steps addresses an unmet need for many patients who struggle with handling traditional blood glucose meters, test strips, lancets, and lancing devices. The introduction of new coverage codes—Healthcare Common Procedure Coding System (HCPCS) codes E2104 for the monitor for use with integrated lancing/blood sample testing cartridge and A4271 for the integrated lancing and blood sample testing cartridges—enables Medicare beneficiaries, who previously lacked access to this new technology, to acquire POGO Automatic under their Medicare Part B coverage.

Intuity Medical, Inc., founded with the mission of simplifying life for people with diabetes, introduced the FDA-cleared POGO Automatic® Blood Glucose Monitoring System. This innovative system streamlines testing with its all-in-one design, eliminating the need for separate strips and lancets. Manufactured in the U.S., POGO Automatic cartridges are produced at the company’s headquarters in Fremont, California.

What You Should Know: 

– Intuity Medical, Inc., a commercial-stage medical technology and digital health company focused on making life with diabetes easier, today announced that the POGO Automatic® Blood Glucose Monitoring System is now available at the more than 2,200 U.S. pharmacies of Kroger Health, the healthcare division of The Kroger Co. 

– With POGO Automatic Monitors and Cartridges now available at all Kroger Health pharmacy locations, the simplicity of One-Step testing is easily accessible to many people with diabetes.

Why It Matters

Many people with diabetes struggle with the burden of testing blood glucose with traditional glucose meters because it can be complicated, there’s a lot to carry around, and it can be very disruptive to everyday life.

“For people with diabetes, consistent blood glucose monitoring is essential for managing their disease, but the barriers presented by traditional meters can prevent them from testing regularly,” said Emory Anderson, president and CEO of Intuity Medical, Inc. “Intuity Medical is proud to share a joint commitment with Kroger Health pharmacies to make glucose testing simpler for customers with diabetes. We’ve done this by providing POGO Automatic’s One-Step™ testing, which automatically does the work of lancing and blood collection, freeing people with diabetes from the hassles of traditional glucose testing.”

POGO Blood Gllucose Monitoring: How It Works

POGO Automatic, from Intuity Medical, is the first and only FDA-cleared automatic blood glucose monitor with 10-test cartridge technology that automatically lances, collects blood, and produces a glucose result at the push of a button and doesn’t require people with diabetes to carry or load separate lancets and test strips.

Testing blood glucose with POGO Automatic is simple and automatic. With everything needed for 10 tests integrated into a single cartridge, users never again have to handle separate lancets or test strips. They can discreetly test and obtain an accurate glucose result in a matter of seconds, without everyone noticing.

Eligible, privately insured patients can now save by filling prescriptions at Kroger Health pharmacies for POGO Automatic Test Cartridges and/or a POGO Automatic Monitor through the POGO Automatic Prescription Savings Program. Participants will pay no more than $59 for up to 150 tests per prescription and can receive a no-cost POGO Automatic Monitor with a prescription. 

What You Should Know:

– In an effort to make blood glucose data more actionable for providers and patients alike, Rimidi, a leading clinical management platform announced its integration with the ARKRAY GLUCOCARD® Shine Connex Blood Glucose Monitoring System to Rimidi’s Platform.

– The integration enables providers to manage blood-glucose control more proactively within existing workflows, thus boosting patient adherence.

Blood Glucose Data Directly Embedded in EHR

Diabetes is the most expensive chronic condition in the nation, with more than $237 billion spent each year on direct medical costs, and another $90 billion on reduced productivity. With over 37 million people in the U.S. currently living with the condition, patients must have access to reliable and affordable blood glucose monitoring systems. The integration between Rimidi and ARKRAY enables providers to see blood glucose data in their EHR existing workflows, thus providing a more comprehensive view of patients’ health, and in turn driving better clinical decisions. For example, providers are alerted when a patient has an out-of-range reading or has not taken their blood-glucose in a certain amount of time, prompting them to follow up with their patient accordingly.

“With a large portion of the U.S. population living with diabetes, and a significant amount living in areas with poor cellular service, patients need devices that they can rely on to monitor their conditions without having to schedule an in-person appointment with their provider,” said Lucienne Ide, MD, PhD, Founder and CEO of Rimidi. “Through our partnership with ARKRAY, we’re tackling these challenges head on, ensuring more patients and providers have the tools they need to properly monitor conditions and make actionable insights that improve health outcomes.”

What You Should Know:

– After taking part in proving the clinical benefit of using AI-based decision support tools, as was recently published in Nature Medicine, Yale New Haven Health System and DreaMed Diabetes announced a collaboration that will explore what it would take to adopt such a solution into a real-world health system.

– As part of the collaboration, Yale New Haven will utilize DreaMed’s Advisor Pro platform to create a virtual clinic, this real-world evaluation will assess the onboarding of 100 pediatric patients with diabetes. Participants of the program will receive the benefits of optimization of their treatment regimen either in a fully remote treatment environment or with virtual visits supplementing the standard of care quarterly in-person visits they would have for the duration of six months. Continuous glucose monitor, or blood glucose monitor, data will be integrated with information from patients’ insulin pumps forming the basis for treatment optimizations that will be recommended by the DreaMed Advisor platform, which must be approved by clinicians prior to dispersing the alterations to the patient.

– During the evaluation, different aspects of the treatment will be measured to assess how effectively they perform compared to conventional methods. This will include gauging satisfaction levels, both from the participant and the provider, as well as factoring in financial considerations, the effectiveness and precision of the treatment, the flow of service, and the ease through which administering changes can be applied.

– The DreaMed Advisor platform offers personalized optimization of insulin therapy management, driven by a technology that runs on artificial intelligence (AI) and algorithms. Recommendations are based on analysis of information derived from CGM, glucometers, insulin pumps, and the use of event-oriented data.

What You Should Know:

– Abbott has received CE Mark (European approval) for its next-generation FreeStyle Libre 3 system for people with diabetes.

– FreeStyle Libre 3 is the latest advancement from Abbott’s FreeStyle Libre family of products and featuring the smallest, thinnest continuous glucose monitoring (CGM) sensor (~size of two stacked U.S. pennies) and a more environmentally sustainable system design.

Abbott, the worldwide leader in continuous glucose monitoring (CGM) technology, announced today it has secured CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe. The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones every minute, offering unsurpassed 14-day accuracy in the smallest and thinnest3 sensor design at the same affordable price as previous versions of the device. This is the first time Abbott has changed the sensor design since the initial FreeStyle Libre launch to be even more discreet for an enhanced user experience.

FreeStyle Libre 3 is the latest advancement from Abbott’s FreeStyle Libre family of products and features the following:

– The smallest, thinnest continuous glucose monitoring (CGM) sensor (~size of two stacked U.S. pennies) and a more environmentally sustainable system design

– Priced the same as previous generations of the device (which is ~70% less than other CGMs) to ensure as many people as possible living with diabetes have access

– The only CGM with real-time glucose readings and optional alarms automatically delivered to your smartphone every minute via the FreeStyle Libre 3 mobile app

– The longest-lasting, self-applied CGM available (14 days compared to other CGMs at 10 days) with unsurpassed performance and accuracy to make living with diabetes easier

Data also show use of the FreeStyle Libre system reduces diabetes-related hospital admissions and work absentee rates to help improve quality of life.

Availability

Abbott is launching the FreeStyle Libre 3 system in Europe in the coming months. The FreeStyle Libre portfolio has been clinically proven to improve glucose control, increase time in target glucose range, decrease time in hyperglycemia (high glucose levels) and hypoglycemia (low glucose levels), and lower HbA1c (average glucose levels over a three-month period) – all factors contributing to better health outcomes.  Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S.

“Abbott won’t stop innovating when there’s room to raise the bar. We’ve done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “People living with diabetes are at the center of our design process, and we made our next-generation technology even more discreet for a better user experience to make managing diabetes as easy and seamless as possible.”

“Since we launched the first disposable glucose sensor in 2014, we’ve always believed all people with diabetes should have access to high-quality, accurate and affordable diabetes technologies,” said Watkin. “That’s why Abbott disrupted the traditional notion that CGMs have to sacrifice quality or accuracy for affordability, and we built our FreeStyle Libre family of products to deliver unparalleled results at a lower cost than any other CGM available.”

What You Should Know:

– Ascensia Diabetes Care and VisiQuate announced a partnership to expand beyond blood glucose monitoring and provide holistic diabetes management solutions.

– The overall solution will provide integration with Ascensia’s existing devices and digital diabetes solutions to enable it to capture data from patients who have consented to provide their information.

Ascensia Diabetes Care, a Santa Rosa, CA-based provider of blood glucose monitoring systems (BGMS) is teaming up with VisiQuate, a healthcare analytics company on their digital diabetes management platform. The strategic partnership will serve as a key element of their strategy to expand beyond blood glucose monitoring and provide holistic diabetes management solutions.

Integration Details

The overall solution will provide integration with Ascensia’s existing devices and digital diabetes solutions to enable it to capture data from patients who have consented to provide their information. The platform will then provide analytics for contracted health plan clients, analytics and engagement for involved providers, and internal analytics to support Ascensia’s business operations. It will also include a diabetes educator platform.

“The future of diabetes management is more than just using devices and medications. Collecting and analyzing data to provide actionable personalized management recommendations will be critical to improving the health and lives of people with diabetes. We believe in the importance of building a robust data platform that can enable us to capture data and offer management solutions for patients, physicians and health plans,” explained Martin Gerber, Global Head of Innovation, Ascensia Diabetes Care. “We looked at a great number of patient-centric solutions in this space and saw that VisiQuate’s HealthMobile.D solution and data platform was the best option to support our data strategy. We are excited to be working with a market leader in this field to implement this new platform for our business and offer a new data driven option for people with diabetes.”

One Drop, a digital blood glucose monitoring kit for diabetes management will now be available in select retail Apple stores, CNBC reports. Currently sold online in the Apple Store for $69.95, the digital diabetes kit includes a Bluetooth glucose meter, test strips, lancets (optional), and one year of free coaching from a certified diabetes coach.

One Drop Blood Glucose Monitor

One Drop’s blood glucose meter ensures clinically proven accurate, reliable results in just five seconds. The meter then wirelessly transmits that blood glucose data via Bluetooth to the One Drop Mobile app on your iOS device. Exceeding all FDA and CE requirements, the meter is compatible with the iPhone, Apple Watch, iPad, and iPod touch. Through the app, it lets you track everything in one place: blood glucose, food, medication, and activity.

The company recently expanded its AI-powered Predictive Insights to include 8-hour blood glucose forecasts for One Drop | Mobile iOS users with type 2 diabetes, including those on oral medications and/or basal insulin regimens, making One Drop the only provider of blood glucose forecasts for people with type 2 diabetes. Additionally, the One Drop app offers an easy-to-use Personal Health Assistant — a digital tool for monitoring medication, food and physical activity as well as blood sugar, blood pressure, weight, and other health markers.

Financial Impact of Diabetes in the U.S.

In the USA, 1 in 11 people has diabetes, costing the healthcare system more than $150 billion annually. For these individuals, maintaining blood glucose in the normal range (80–180 mg/dL) is a critical part of reducing emergency department visits, hospitalizations, renal failure and other costly complications of diabetes.

“The healthcare industry is deeply invested in resisting progress, but consumerized, data-driven, digital health is becoming a reality,” said Jeff Dachis, One Drop Founder and CEO. “Diabetes affects more than 30 million Americans today, many of whom face a tremendous amount of stigma and lack of adequate support from an over-burdened system. One Drop is shifting value towards the consumer, while remaining relentlessly focused on improving outcomes and quality of life.”

DarioHealth Corp., a blood glucose monitoring system has announced a joint marketing agreement with Glytec, a provider of insulin titration solutions. As part of the partnership, Dario Blood Glucose Monitoring System is now available to hospitals and health systems using Glytec’s virtual insulin titration service for outpatients with diabetes.

Integration Details & Benefits

Blood glucose data from the Dario Blood Glucose Monitoring System automatically sent to the Cloud in real-time, will be seamlessly imported to Glucommander Outpatient™ and utilized in conjunction with other clinical data to formulate personalized insulin dose recommendations. The connected care model supports virtual insulin titration for outpatients with diabetes.

The Dario Blood Glucose Monitoring System Overview

The Dario Blood Glucose Monitoring System combines five essential tools to simplify diabetes management: (1) a sleek, all-in-one smart glucose meter, (2) a personal diabetes progress monitor, (3) on-demand data sharing, (4) emergency hypoglycemia alerts with GPS locator, and (5) a carb counting tool.

“Glytec will benefit from real-time, accurate blood glucose data to provide insulin titration decision support, and we are convinced that the Dario Blood Glucose Monitoring System will be a more complete solution when paired with Glucommander™ Outpatient,” said Erez Raphael, DarioHealth’s Chief Executive Officer. “We believe that people with diabetes need this synergy to be most successful in managing their diabetes.”

Applied Health Signals company Livongo Health, today announced the launch of the Study to Understand Gaining Access to Blood Glucose Records (SUGAR), or SUGAR study, a randomized controlled trial in collaboration with the University of California, San Francisco (UCSF). The aim of the clinical trial is to measure the impact of the Livongo for Diabetes program compared to the average standard of care approach to diabetes management utilizing a traditional Bluetooth glucose meter.

SUGAR Study Background/Overview

The randomized controlled clinical trial will randomize 300 people with diabetes to either participate in the Livongo for Diabetes program, which includes a cellular-connected blood glucose meter, unlimited free test strips, remote digital and 1:1 coaching with Certified Diabetes Educators, or receive a Bluetooth glucose meter and unlimited free test strips.

HbA1c is a commonly accepted lab measure for average blood glucose levels over a 90-day period. The HbA1c level can be a marker of the effectiveness of a diabetes management solution. The final results of the study will compare hemoglobin A1c (HbA1c) changes in both populations at six months.

SUGAR Study Participants

SUGAR study participants include:

● People with a diagnosis of type 2 diabetes mellitus on any type of medication

● Adults, age 18 years or older

● People not using a continuous glucose monitoring device nor an insulin pump

● iPhone users with access to data and/or Wi-Fi

Livongo for Diabetes Program

The Livongo for Diabetes program is backed by a team of data scientists who Aggregate, Interpret, Apply and Iterate (AI+AI)™ substantial amounts of health data and information to create actionable, personalized and timely insights, information and nudges to improve how Livongo members experience their chronic condition. “We are interested to see how an innovative solution like Livongo truly impacts people,” said Jenise Wong, MD, Ph.D., Assistant Professor at UCSF and Principal Investigator of the SUGAR study. “By conducting a randomized controlled trial, we can better understand the degree to which innovative offerings improve health outcomes.”

To date, Livongo has demonstrated positive health outcomes, and studies show that Livongo delivers cost savings. 

Smart Meter, LLC, makers of the iGlucose® Cellular Diabetes Care Solution, announced its integration with Validic, a healthcare data connectivity platform. The integration brings a simple, convenient and affordable diabetes management solution to people with diabetes, healthcare teams, and population management programs. 

The iGlucose solution, which uses cell-enabled technology to automatically transmit real-time blood glucose results, removes complex technology issues by automatically transmitting real-time blood glucose (BG) results that can be viewed and acted on by a healthcare team. 

With the integration of iGlucose into the Validic platform, health systems and corporate wellness leaders can now offer an effective diabetes management program that fits easily into busy lives. When an iGlucose user checks their blood glucose, the healthcare team can receive near real-time, actionable data and has the information to confidently treat their patients. 

The iGlucose Solution eliminates the day-to-day hassles of cables, syncing devices and downloading apps for people with diabetes. Healthcare teams can easily engage patients by viewing real-time results and seeing when their patients’ BG results are out of range. iGlucose enables and supports the new CMS reimbursable remote patient monitoring program (CPT 99091) that requires patient-generated, digitally stored data.

BioTel CareTM (formally known as Telcare), a BioTelemetry company has announced the release of its next-generation wireless blood glucose monitor for diabetes management. BioTel Care developed the first FDA-cleared, cellular-enabled glucometer which supports real-time transmission and consolidation of patient data in an FDA-cleared cloud.  

Building on the success of this technology, BioTel Care is launching its next-generation blood glucose monitor, which includes an innovative touch-screen user interface, enabling patients to easily test blood glucose levels while capturing additional personal health data.

The monitor’s remote capabilities allow patients to quickly communicate a wide range of relevant health information to their care providers.  Clinicians can access and track their patients’ data through the BioTel Care cloud and can provide immediate feedback, as needed, directly to their patients via the new monitor’s messaging feature.  

Patients can also track their own data with informative graphical summaries available on the monitor.  Both clinicians and patients will benefit from the system’s ability to be paired with other connected health devices, providing the option to consolidate various types of health information into a single, cloud-based repository.  

“This next generation blood glucose monitor is a great addition to our product portfolio and continues our commitment to innovate connected health solutions suited for today’s rapidly evolving healthcare market.  The design emphasizes usability, encouraging greater compliance and improved patient engagement. The BioTel Care monitor also features the ability to consolidate data from other connected health devices, uniquely positioning us to move beyond diabetes and into the management of other chronic conditions,” said Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, Inc.