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:

– Digital diabetes management tools are failing to deliver meaningful health benefits to patients, according to a new evaluation by the Peterson Health Technology Institute (PHTI).

– The report casts doubt on the effectiveness of widely used digital diabetes management tools. Despite billions in investment, the study finds these tools offer minimal health benefits and actually increase healthcare spending.

Millions Rely on Tools, But Evidence Shows Little Impact

The PHTI analysis focused on eight popular tools for tracking blood sugar (non-continuous glucose monitors) used by people with Type 2 diabetes. While these tools promise better health outcomes and cost savings, the research paints a different picture:

• Small, Unsustained Improvements: HbA1c reductions, a key diabetes measure, were minimal (0.23 to 0.60%) and didn’t last over time. These results fall short of the industry standard for meaningful change.
• No Broader Health Benefits: The study found no significant improvements in weight, blood pressure, cholesterol, or other diabetes-related health factors.
• Increased Costs for All Payers: The price of these tools outweighs any cost savings because the minimal benefits don’t prevent other treatments or care. Annual spending is projected to increase across all insurance types:
  • Commercial: +$2,002
  • Medicare: +$1,011
  • Medicaid: +$723

Bright Spots and Recommendations

The report identifies two potential areas for improvement:

• Virta’s Nutritional Ketosis Approach: Early data suggests Virta’s program, which requires strict dietary changes, may lead to diabetes remission for some patients.
• Early Intervention with High-Risk Patients: Digital tools might be more impactful for newly diagnosed patients with high starting HbA1c levels, helping them establish better self-management habits.

PHTI offers recommendations for the future of digital diabetes management:

• Focus on Clinically Meaningful Benefits: New tools should aim for substantial HbA1c improvements, potentially integrating continuous glucose monitors and new medications.
• Rigorous Evidence for Adoption: Developers need to generate stronger evidence to justify wider use.
• Prioritize Access and Affordability: Solutions should be accessible for those who need them most and come at a lower cost than standard care.

Moving Forward: Transparency and Better Tools

The PHTI report calls for more transparency from providers and payers:

• Providers: Doctors need clear information on tool performance before recommending them to patients.
• Payers: Health plans and employers should require evidence of tool benefits and tie financial coverage to clinical outcomes.

“When these digital diabetes management tools launched more than a decade ago, they promised to improve health outcomes for people with diabetes and deliver savings to payers. Based on the scientific evidence, these solutions have fallen short, and it is time to move toward the next generation of innovation,” said Caroline Pearson, executive director of PHTI. “Patients with diabetes invest time, energy, and resources in these tools, and they deserve to experience meaningful, positive benefits for their health. The healthcare sector as a whole needs transparent, accurate information about the clinical and economic impact of these digital tools that are taking up precious healthcare dollars.”

This research aims to guide healthcare decision-making and accelerate the development of truly effective digital solutions for diabetes management. PHTI plans to conduct similar evaluations for virtual physical therapy, blood pressure monitoring, and mental health tools.

Click here for more information about the report.

What You Should Know: 

• During the ADA’s annual scientific sessions in San Diego on Saturday, Abbott and Weight Watchers unveils its new new connected app experience for people living with Type 2 diabetes. 
• The connected app experience, which is available now for people living with Type 2 diabetes, syncs key glucose data from Abbott’s FreeStyle Libre 2 continuous glucose monitoring system within the WeightWatchers app, allowing people to learn how food and activity impact their glucose levels. 
• The experience is guided by the WW Diabetes-Tailored Plan to make healthier choices – so one can lose weight and lower their A1C.

WeightWatchers x Abbott Connected Experience Features

Key features of the connected experience app include: 

• Glucose Card: view current glucose level and Time-in-Range for the day
• Glucose Tab: view current glucose level, daily glucose readings, and your glucose event log — readings outside the standard target range and the meals or activities that may have affected them.
• Time in Range Tab: Check three different TIR values (Today, Last 14 Days, Last Month) to understand day-to-day snapshot along with the bigger picture.

What You Should Know:

– The digital diabetes market is on track to reach $1.5 billion dollars by 2024, according to a new report by Research2Guidance.

– The confident growth of digital diabetes care will be driven by the growth of the global addressable market for digital diabetes services. Between 2019 and 2024, the number of diagnosed diabetics with access to smart devices is set to increase from 109 million to 180 million. 

– Digital diabetes solutions have disrupted the diabetes care market and are changing overall chronic care, targeting not only diabetes but also its various comorbidities, such as obesity, hypertension, and depression.

– The report, The Global Digital Diabetes Care Market 2020: Going Beyond Diabetes Management focuses on the continued expansion of digital diabetes providers into other chronic conditions (vertical expansion) and new service opportunities (horizontal expansion), highlighting the market’s strategic direction in the next few years. This expansion will create new revenue opportunities, improve payer acceptance, and grow user bases beyond the diagnosed diabetes audience.

– In the report, the Top 10 market players LifeScan Inc., Ascensia Diabetes Care, Informed Data Systems (One Drop), mySugr (Roche), H2 Inc., Livongo Health, Omada Health, Abbott, Dexcom, and Dario Health are profiled with their offerings, mobile app portfolio performance, and strategy analysis, as well as Top 10 country profiles (market opportunity size, number of solutions, downloads, number of users, Top 5 players).

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.”

What You Should Know:

– Connecticut state Comptroller Kevin Lembo announces the launch of Livongo for Diabetes Management Program through the state health plan to deliver estimated annual savings to the state of approximately $3 million.

– The program, launched in partnership with CVS Caremark and Livongo, is projected to significantly improve health care outcomes for thousands of people with diabetes covered by the state plan by providing them with comprehensive around-the-clock live coaching and support through cellular-enabled diabetes management devices with remote monitoring capabilities.

The State of Connecticut Comptroller Kevin Lembo today announced the launch of a diabetes management program powered by Livongo through the state health plan aimed at reducing acute emergencies and long-term complications related to chronic conditions while delivering an estimated annual savings to the state of approximately $3 million. More than 500 people have already signed up for the program during a two-week soft launch period, and more are enrolling each week.

CVS/Livongo Partnership

The program, launched in partnership with CVS Caremark and Livongo, is projected to significantly improve health care outcomes for thousands of people with diabetes covered by the state plan by providing them with comprehensive around-the-clock live coaching and support through cellular-enabled diabetes management devices with remote monitoring capabilities.

As state comptroller, Lembo is the administrator of the state health plan, which serves more than 250,000 state and municipal employees, retirees and their dependents. This diabetes management program is the latest cross-sector partnership that seeks to enhance the efficiency of the state plan by helping members to better manage chronic conditions.

Livongo Diabetes Management Program Overview

The Livongo diabetes management program and devices will allow members to monitor their conditions, receive Health Nudges™, and 24/7 access to digital and telehealth coaching, all from the safety of their homes. The program is modeled after similar efforts that have a proven track record of success. A Journal of Medical Economics study found that the Livongo for Diabetes program delivered an $88 per member monthly reduction in medical spending and that clients experienced a positive return on investment in one year.

Benefits for Plan Members

The program is designed to provide several benefits to plan members and the state by:

– Providing more supportive, successful preventative care to members at no cost to them that results in better health care outcomes;

– Addressing the state’s top pharmacy cost category (diabetes medication and supplies);

– Expanding on the state’s HEP (Health Enhancement Program philosophy) of delivering more quality and smarter preventive care;

– Enhancing physician and member dialogue;

– Providing ongoing support for people with diabetes to bridge the gap between members’ everyday lives and the physician’s office; and

– Operating the state plan more efficiently and achieving potential annual savings of $3 million.

“Our goal is to give workers and their families every chance of success to live safe and healthy lives,” Comptroller Lembo said. “There are more than 15,000 people covered by the state plan living with diabetes who are at risk of completely avoidable dangerous complications – including emergency care for hyperglycemic episodes, high blood pressure, stroke, kidney disease, ketoacidosis and eye and skin problems and infections. This program is about avoiding the avoidable through smarter health care.”

“Those with chronic conditions are not more likely to be infected with COVID-19 – but they are at greater risk of complications if they get it,” Lembo said. “The launch of this program comes at a critical time when the need to provide access to quality and preventive care for chronic conditions is especially clear.”

– Welldoc and Redox announce a partnership to ensure bidirectional integration with EHR with Welldoc’s digital health solution for diabetes management, BlueStar.

– This partnership will allow providers to receive and review insights about users of Welldoc’s BlueStar digital health app for diabetes management directly within their EHR at the point of care.

 Welldoc, a digital health company revolutionizing chronic disease management, announced today its strategic partnership with Redox Inc., the leading interoperability platform for healthcare data exchange. The partnership will allow providers to receive and review insights about users of the BlueStar^® digital health app for diabetes management directly within their EHR at the point of care.

Optimizing Clinical Decision Support with Real-Time Patient Data

With a shared vision to improve health outcomes of patients and alleviate physician burden, Welldoc and Redox are positioned to optimize clinical decision support by making more patient data available in real-time. This is critical for patients managing a chronic disease.

Welldoc’s digital health tools work with the Redox network to ensure products are capable and securely executing meaningful, bidirectional integration workflows with a vendor-agnostic platform for healthcare data exchange. Today, more than 600 healthcare organizations using 45 EHR vendors trust Redox to strategically integrate digital health solutions into their day-to-day operations. Through this partnership, Welldoc’s BlueStar is immediately interoperable with any organization using Redox for healthcare data exchange to optimize the provider and patient experience.

Why It Matters

With one in four American adults managing multiple chronic conditions today, patients are seeking ways to better self-manage health outside of the clinical setting. BlueStar provides precise, AI-based real-time feedback focused on engaging patients to manage their health with clinical decision support.

 BlueStar^® was the first FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes. By helping individuals with chronic disease self-manage their conditions and connecting them to their own healthcare team, Welldoc streamlines payers, employers and healthcare systems resources by focusing on a digital health solution to help better manage their populations living with multiple and costly chronic diseases.

“Digital therapeutics done right is a godsend for patients managing a chronic disease,” said Luke Bonney, co-founder and CEO of Redox. “The power of a caregiver in your pocket 24/7 cannot be overstated. Welldoc is fundamentally changing the way patients live with diabetes and establishing a standard for the industry with a commitment to integrations with CGMs, wearables, and EHRs. We are excited and proud to be a part of Welldoc’s mission and to ensure that the actionable insights derived by the BlueStar platform are made available to providers in an optimal way.”

– Livongo announced an expanded partnership with Blue Cross and Blue Shield of Kansas City to provide Livongo for Diabetes program to all Blue KC fully insured clients.

– Blue KC was an early Livongo adopter and this expansion provides momentum as we continue to expand from working primarily with self-insured employers to broader markets including fully insured populations of our health plan clients.

Livongo Health, Inc. (Nasdaq: LVGO), an Applied Health Signals company empowering people with chronic conditions to live better and healthier lives, announced that it has expanded its partnership with Blue Cross and Blue Shield of Kansas City (Blue KC) to offer the Livongo for Diabetes program to all Blue KC fully insured clients. In addition, Livongo is now available to eligible Blue KC Administrative Services Only (ASO) clients.

The Livongo for Diabetes program is a whole person platform focused on empowering members with education and tools to self-manage their diabetes through mobile technology. The program offers members a cellular-enabled, two-way messaging device that measures blood glucose and delivers personalized insights, free unlimited supplies, and access to Certified Diabetes Educators for instant support and goal setting.

Livongo for Diabetes Program Results for Blue KC Clients

To date, Blue KC clients using Livongo demonstrated a combined +75 NPS score and a significant decrease in eHbA1c. Blue KC is the largest not-for-profit health insurer in Missouri, the only not-for-profit commercial health insurer in Kansas City, and provides health coverage services to more than one million members.

More than 720 organizations, including more than 20 percent of the Fortune 500 self-insured employers, health systems, health plans, and the two leading pharmacy benefit managers have implemented Livongo solutions.

Why It Matters for Blue KC Clients & Plan Members

“As the chronic condition epidemic in the United States continues to progress, it is paramount that healthcare organizations find solutions that address these conditions and the related costs,” said Raelene Knolla, D.O., Department Vice President and Senior Medical Director for Blue KC. “Through a combination of technology, data science, and coaching, Livongo has proven its effectiveness in delivering a great experience that bends the cost curve for organizations who provide health coverage services. We are excited for our continued work together and for the prospects of improved outcomes and cost savings for our Clients and Members.”

– Livongo announced a partnership with VSP Vision Care to offer mutual Members resources and insights to manage chronic conditions and vision care on one platform.

– People with diabetes and prediabetes have an increased risk of vision complications and vision loss and by offering them resources to better manage their eye health on the Livongo platform, we can effectively close gaps in care. 

Livongo Health, Inc., an Applied Health Signals company empowering people with chronic conditions to live better and healthier lives, today announced a partnership with VSP® Vision Care to expand outreach efforts to Members with diabetes. This partnership includes the opportunity for mutual clients to provide their employees with important reminders to schedule their annual comprehensive eye exam with a VSP network doctor.

Livongo Solutions Now Available to VSP Employees & Their Dependents

As part of the collaboration, Livongo will now offer its Diabetes, Hypertension, and Behavioral Health solutions to VSP employees and their dependents. Under most VSP plans, Members with diabetes receive a covered-in-full retinal screening and are eligible for additional exams and services at the discretion of their VSP network doctor. Through the program, mutual Members will also receive communications encouraging them to connect with a local VSP network doctor, via VSP’s ‘Find a Doctor’ tool. VSP clients interested in adding Livongo’s chronic condition management services can contact their VSP Market Director.

“Livongo’s partnership with VSP Vision Care is another important step for us as we continue to enhance our Applied Health Signals platform and shows how Livongo’s consumer-first mindset leads to innovations that improve our overall Member experience,” said Livongo President Dr. Jennifer Schneider. “Vision is an important piece of the healthcare experience for people living with chronic conditions, and especially diabetes. By seamlessly offering resources and insights to manage chronic conditions and vision care on one platform, we can better address the whole person and make it easier to stay healthy.”

Impact of Diabetes on Eye Vision

The Centers for Disease Control estimates that more than 100 million Americans have diabetes or prediabetes. People living with diabetes or prediabetes have an increased risk of glaucoma, cataracts, and is a leading cause of vision loss due to retinopathy. Having an annual comprehensive eye exam is critical for everyone, but especially for people with diabetes, as it can play a role in preventing or delaying blindness due to the condition.

“Chronic conditions like diabetes continue to take an unprecedented toll on so many lives, yet comprehensive eye care is a simple, but often overlooked way of preventing vision loss,” said Kate Renwick-Espinosa, President of VSP Vision Care. “As the leader in vision care for people with diabetes, we’re proud to partner with Livongo and offer our clients, members, and employees an effortless way to keep their eye health top of mind and help drive better health outcomes overall.”

– One Drop’s wireless glucose meter kit and supplies for diabetes management are now available at hundreds of Walmart stores in the United States.

– Retail expansion increases accessibility of healthcare technology and support for people with chronic conditions such as diabetes and hypertension.

One Drop, a New York City-based provider of digital therapeutic solutions for diabetes and other chronic conditions, today announced that its wireless glucose meter kit and supplies are now available at hundreds of Walmart stores in the United States. Each kit includes a Bluetooth glucose meter, lancing device, carry case, test strips, and lancets, as well as one year of free access to One Drop’s certified diabetes coaches for 24/7 support.

In addition to being sold at US Walmart stores and on walmart.com, One Drop’s wireless glucose meter is currently available at select Apple retail locations, and on getonedrop.com, amazon.com, bestbuy.com, and apple.com.

Automated Decision Support: One Drop Can Predict Blood Glucose

One Drop’s integrated platform offers an easy and effective way for people to track and manage a variety of health conditions. With A.I.-powered behavioral recommendations, dedicated one-on-one coaching recognized by the American Diabetes Association, and thousands of app and device integrations, One Drop provides personalized health programs to drive sustainable behavior change as part of a diabetes management plan.

One Drop’s efficacy has been established in more than 20 peer-reviewed studies, which show that people with diabetes using One Drop decreased their A1c (average blood glucose levels) in as little as one month. Ninety-two percent of people using One Drop’s AI-powered Predictive Insights report that they find the information helpful in their diabetes management.

Impact of Inadequate Diabetes Care

In the current healthcare climate, nearly 4 billion people lack access to medical care. In the United States alone, more than 10% of the population lives without health insurance. Where medical intervention is available, access to treatment options is stratified by wealth and income inequality. As a result, the majority of low-income individuals have limited, if any, access to life-sustaining insulin, oral hypoglycemic agents, and other medications critical to gaining control of diabetes, including blood pressure and cholesterol medicines. According to research, worldwide losses in GDP from 2011 to 2030, including direct and indirect costs of diabetes totaled $1.7 trillion dollars.

“When I was diagnosed with diabetes more than ten years ago, my high-deductible health plan — and the fact that I lived more than 100 miles away from the closest endocrinologist — left me feeling like I was on my own,” said One Drop user Julie Beck. “Now, I have instant access to my certified coach, who can answer questions like whether I should consider talking to my doctor about adjusting my meds. And with the predictive insights, I no longer worry that I might experience a sudden blood sugar low while driving and cause an accident. I’m thrilled that One Drop is now available at Walmart stores so that more people living in remote areas like me can get the help they need to take control of their health.”

– Livongo has been awarded a contract to provide the Livongo for Diabetes solution to eligible members covered by the Federal Employees Health Benefits Program (FEHBP ) under one health plan.

– The contract is Livongo’s biggest contract in company history and will account for $20-25M in revenue in 2020 and $30-35M in revenue for 2021, representing a total of $50-60M including both years.

– The announcement reflects Livongo’s overall market traction and how they are expanding from working primarily with self-insured employers, to broader and larger markets including government employees, labor unions, and fully-insured populations.

Livongo Health, Inc (Nasdaq: LVGO), an Applied Health Signals company empowering people with chronic conditions to live better and healthier lives, today announced it was awarded a contract to provide the Livongo for Diabetes solution to eligible members covered by the Federal Employees Health Benefits Program (FEHBP) who are living with Type 1 or Type 2 diabetes under one health plan covering 5.3 million federal employees, retirees, and their families out of the nearly 8 million people who receive their benefits through the FEHBP. 

Largest Contract in Company History Makes Livongo for Diabetes a Covered Benefit

Livongo signed a two-year agreement which will launch the Livongo for Diabetes program starting on January 1, 2020, and expects a 9 to 12-month deployment period to those eligible members living with diabetes. Livongo expects that this agreement will add approximately 25,000 Livongo for Diabetes Members in 2020, growing to approximately 45,000 Members in 2021. This is larger than the expectation of 20,000 to 30,000 total Members previously disclosed by Livongo. Based on this updated expected enrollment, Livongo anticipates the contract through the FEHBP will account for $20-25M in revenue in 2020 and $30-35M in revenue for 2021, representing a total of $50-60M including both years.

Contract Opens Government Sector Business for Livongo

The new contract reflects Livongo’s overall market traction and how they are expanding from working primarily with self-insured employers, to broader and larger markets including government employees, labor unions, and fully-insured populations. Livongo’s Applied Health Signals platform leverages advanced technology and data science to understand people’s unique health needs and then provide clinically-based guidance, or Health NudgesTM, to drive positive behavior change. The Livongo for Diabetes solution leads to higher Member satisfaction, improved clinical outcomes, and lower overall healthcare spending.

A 2019 study demonstrated that 94 percent of Livongo for Diabetes program Members who completed a program survey achieved improved Diabetes Empowerment Scale – Short Form (DES-SF) or Diabetes Distress Scale 2 (DDS2) in year one of the Livongo for Diabetes Program; effectively improving confidence in diabetes self-management, while decreasing burnout related to diabetes management. A separate 2019 study published in the Journal for Medical Economics showed that the Livongo for Diabetes program delivered an $88 per Member per month reduction in medical spending for Livongo Members when compared to the matched non-Livongo population and that employers experienced a positive return on investment in one year.

“This win highlights two of our competitive advantages. First, government entities and large plans want to see multi-year, clinically validated results at scale and only Livongo has that independently validated data. Second, our AI+AI engine, which aggregates information from our own devices, electronic health records, pharmacy records, smart watches, and continuous glucose monitors interprets that information, applies it back to our Members to learn what works, and then iterates using Health Nudges™, is making us smarter and more Member focused every day,” said Dr. Jennifer Schneider, M.D., M.S., President of Livongo.

The U.S. Food and Drug Administration (FDA) has permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, Referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable insulin pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences.

The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.

Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.

t:Slim X2 Insulin Pump Overview

The interoperable t:Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as AID systems, or, when not connected to other devices, the interoperable t:Slim X2 pump can be used to infuse insulin on its own. AID systems typically consist of a pump, CGM, and software to control the system.

Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type.

Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. With the authorization of the interoperable t:Slim X2 insulin pump and the establishment of these special controls, the FDA’s action also created a new regulatory classification, which provides more efficient patient access for this type of device in the future, because future ACE insulin pumps that comply with the general and special controls can go through a more efficient premarket review known as 510(k) clearance.

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, M.D. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.

Livongo Health, an Applied Health Signals company empowering people with chronic conditions to live better and healthier lives, today announced that it has acquired Denver-based myStrength, Inc., a provider of digital behavioral health solutions. Financial terms of the acquisition were not disclosed. 

The acquisition enables Livongo to more fully address the health of the whole person by integrating behavioral health conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia to Livongo’s Applied Health Signals solution. myStrength currently partners with over 130 of the largest health plans and health systems in the country including Medicaid funded community healthcare organizations across 32 states.

Founded in 2011, myStrength greatly enhances traditional care models, while addressing issues of cost, lack of access, and stigma, to deliver mental health and well-being resources at scale. The digital behavioral health platform targets the most prevalent and costly behavioral health conditions ─ empowering consumers with innovative self-care resources to manage and overcome challenges with depression, anxiety, stress, substance use disorder, chronic pain, and sleep. 

myStrength’s evidence-based resources offer digital interactive exercises, self-care modules and daily wellness inspiration, which is personalized to each user. myStrength collaborates with more than 100 health plans, integrated health systems, EAPs, disease management providers, managed and community behavioral health providers, strategic alliances, ACOs and FQHCs.

Acquisition Benefits

Approximately 135 million Americans suffer from at least one chronic condition and 20 percent of adults are also dealing with a behavioral health issue. The acquisition supports Livongo’s focus on rapid market growth, continued investment in data science, deeper integration with clients and partners, and the development of a comprehensive consumer offering to address the health needs of the whole person. 

The integration of myStrength will allow Livongo members to seamlessly manage their chronic conditions and behavioral health on one platform with a clinical grade solution that is at the same time focused on the typical health consumer. 

“The acquisition of myStrength represents Livongo’s first strategic investment to address the full range of behavioral health issues on one platform. We did an extensive evaluation of the digital behavioral health landscape and myStrength was clearly the best provider in the space, based on provable effectiveness, traction, customer base, and user satisfaction. The breadth of behavioral health solutions that myStrength offers will allow Livongo to take an integrated approach to tackle these conditions while helping people living with or at risk for chronic conditions” said Glen Tullman, Executive Chairman of Livongo. “We are excited to welcome the myStrength team to the Livongo family and to combine our capabilities to better serve our members and rapidly growing client base of self-insured employers, health plans, health systems, and pharmacy benefit managers.”

Both organizations have delivered proven solutions that improve clinical outcomes and reduce overall healthcare spending. Separate studies demonstrated that people enrolled in the Livongo for Diabetes program experienced a meaningful reduction in blood sugar and that the program saved $83 dollars per participant per month. myStrength demonstrated that 74% of engaged individuals experience improvement in depression scores and that the program delivered a 4.8x ROI (return on investment). 

“Simply put, myStrength and Livongo are a great fit. We share a commitment to providing solutions that address multiple conditions and deliver measurable outcomes, and we are like-minded when it comes to mission, values, and culture,” said Scott Cousino, Chief Executive Officer and Co-Founder of myStrength, who will join Livongo along with all of myStrength’s employees. “This move will now allow us to focus on both the physical and behavioral health of our members and strengthens our ability to bring our clients a broader, more personalized offering.”

Health2047 Inc., an American Medical Association-backed company that develops and commercializes solutions to transform healthcare at the system level, today announced the spin out of First Mile Care. With $2M in seed funding, First Mile Care is a preventive chronic care startup that is building an affordable, scalable and sustainable platform to improve the lives of people who have prediabetes. 

Development is already underway for First Mile Care’s initial platform offering is based on the proven National Diabetes Prevention Program (DPP) method developed by the CDC, which enables community-based peer-to-peer connection for chronic conditions. The platform will give people living with prediabetes – higher-than-normal blood sugar level but not yet type 2 diabetes – the ongoing support they need to make lifestyle decisions that can reverse prediabetes and reduce the risk that their condition will develop into type 2 diabetes.

The First Mile Care platform is based on the proven National Diabetes Prevention Program (National DPP) developed by the Centers for Disease Control and Prevention (CDC), a coaching program shown to reduce the incidence of type 2 diabetes by 58% compared to placebo. The program recognizes that if lifestyle changes are to be successful, coaching needs to be easy and consistent. This ongoing support provides individuals with the support they need to reduce the risk that their condition will develop into type 2 diabetes. First Mile Care will provide access to certified coaches nearby at an affordable price that is often completely covered by health insurance.

By combining a unique “first-mile” approach with population-level insights gleaned from trusted U.S. institutions like the American Medical Association (AMA) and the Centers for Disease Control and Prevention (CDC), First Mile Care has the orientation and knowledge base needed to significantly reduce chronic disease in the US

First Mile Care is the second company in a year to spin out of Health2047. The first spin out, Akiri, is building a trusted network that enables health information to move seamlessly and securely throughout the U.S. healthcare system.

“Fighting chronic disease requires starting with a scalable approach,” said First Mile Care Founder and CEO, and former Procter & Gamble GM of New Business Healthcare, Karl P. Ronn. “We must build solutions that are both affordable and accessible to everyone in the United States. First Mile Care will establish a network of certified coaches – called First Mile Coaches – in the vast majority of the 42,000 U.S. ZIP codes, enabling coaches to meet people where they live and help them make better lifestyle choices.”

The trends provided above are not suggesting that the digital diabetes care market has already seen its breakthrough, which is yet to come. However, it has all the components to evolve into a mass market in the future: a huge target group, innovative consumer-oriented products and services, working tools for HCPs and payer organizations to support patients, and a proof of concept. In other words, it is ready to ‘take off’ now.