Jan 31,2024 TOP STORY

VBC enabler Valendo Health launches for endocrinologists to provide 'across the board' diabetes care

A new value-based care enabler Valendo Health focused on endocrinology has launched with a mission to shape the future of diabetes care. Valendo Health uses a phased approach to offer expertise, technology and data-rich tools to help independent physicians enhance clinical capacity, streamline operations and transition to value-based care. The startup has announced two initial provider partners: Cecelia Health, a virtual provider for chronic care management, and Advanced Metabolic Care + Research (AMCR), an endocrinology center in Southern California. Through its partnership with Cecelia, Valendo can offer practices like AMCR access to multilingual diabetes educators, nutritionists, nurses and other clinicians “to make sure we can provide care across the board in every community across the country,” CEO Dave Terry said. To date, Cecelia has contracted with large payers, health system and pharma companies—not smaller practices like ACMR. Valendo is now helping it to do so and to learn about the risk-taking business should it decide to pursue value-based arrangements in the future.

COLLABORATION PARTNERSHIP

#institution

#telehealth

#rpm

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Jan 31,2024

Endocrinology company Valendo Health launches with $4M and two provider partners

Valendo Health, a diabetes-focused, value-based endocrinology company, announced its launch with $4 million in seed funding and two providers. The company, built out of Redesign Health, aims to increase revenue for endocrinologists while assisting with the transition to a value-based care model. It offers telehealth and remote patient monitoring services with diabetes care clinicians, an endocrinology-focused EMR, data analytics and assistance with implementing value-based care contracting. The Boston-based company has partnered with two providers: Cecelia Health, a national virtual specialty care provider for chronic care management, and Advanced Metabolic Care + Research, an endocrinology center in Southern California serving patients with diabetes and other metabolic conditions. "At Valendo, we provide endocrinologists the tools to increase clinical capacity and grow practice revenue through virtual care and practice management support, and then we help them transition into value-based contracts." said Dave Terry, CEO and cofounder of Valendo Health.

FUNDING SEED ROUND

#telehealth

#rpm

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Jan 31,2024 TOP STORY

Trinity Biotech Announces Entry into a Letter of Intent with Bayer for a Joint Partnership to Launch a CGM Biosensor Device in China and India

Trinity Biotech announced that it has entered into a non-binding Letter of Intent with Bayer for the launch of a Continuous Glucose Monitoring biosensor device in China and India. This Letter of Intent is related to Trinity’s recently announced acquisition of the CGM assets of Waveform Technologies, Inc. Both parties intend to negotiate a definitive agreement under the framework set by the Letter of Intent in the coming months. The China Joint Partnership intends to leverage Bayer's significant and well-established presence in the Chinese healthcare market, particularly in diabetes, and is intended to lead to the launch of a low cost of care, high quality, CGM device designed to increase affordability and accessibility of diabetes care. To date, CGM use in India is not widespread, but has been trending higher recently with increasing awareness about self-care. Bayer Pharma India has a strong presence in the diabetes market with brands like Kerendia® and Glucobay®.

COLLABORATION PARTNERSHIP

#institution

#cgm

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Jan 31,2024 TOP STORY

Trinity Biotech Announces Acquisition of the CGM Assets of Waveform Technologies

Trinity Biotech announced it has entered into a definitive agreement to acquire the biosensor and Continuous Glucose Monitoring assets of privately held Waveform Technologies for $12.5 million in cash, 9 million American Depositary Shares of the Company and additional contingent consideration. “We plan to begin our journey in a de-risked manner, by using a CGM device that has already received regulatory approval as our platform sensor technology, which we intend to redesign and optimize for broad adoption and then evolve this platform technology to measure and analyse other valuable biomarkers and related datapoints." said John Gillard, Chief Executive Officer. Waveform, a developer of novel and proprietary new technologies for diabetes care, received a CE Mark for its Cascade CGM in 2019, which has since been commercially available in Europe. Waveform will no longer sell the Cascade device and Tinity Biotech will not sell that device in its current form. Trinity intends to design a next generation CGM sensor using Waveform’s platform technology and has secured additional funding from Perceptive Advisors for the next stage of the product’s development. Under the Amended Term Loan, an additional $22 million of funding has been made available to the Company, with $12.5 million being used to acquire the Waveform assets. The remaining $9.5 million is available for general corporate purposes including for the further development of the CGM and biosensor technologies.

COLLABORATION MERGERS & ACQUISITION

#product & service

#cgm

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Jan 27,2024

A New Clinical Trial To Assess Holistic Lifestyle Digital Health Intervention with Women with Post-Gestational Diabetes

A new 4-year study (1-year randomized controlled trial with three years of follow-up) is registered on Clinicaltrials.gov to assess the efficacy of a digital intervention, which focuses on diet, physical activity, sleep and mental well-being, on the glucose regulation of 400 women who previously had gestational diabetes. Women from both intervention and control groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the "HAPPY app," which will provide health promotion information about physical activity, diet, sleep, and mental wellbeing, as well as display the information collected (such as body mass index, blood pressure, and OGTT results). The active group will receive the "LVL UP app" a smartphone-based chatbot-delivered intervention, designed to provide personalized recommendations through multiple digital coaching sessions aimed at improving health literacy and practicing healthy lifestyles to prevent Type 2 diabetes and common mental disorders (i.e., anxiety, depression). The study is led by the Singapore Institute for Clinical Sciences (SICS) at the Agency for Science, Technology and Research, in collaboration with the National University of Singapore’s (NUS) Yong Loo Lin School of Medicine and the Singapore-ETH Centre.

CLINICAL STUDY

#mobile app

#coaching

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Jan 23,2024

Smartphone Applications to Prevent type 2 Diabetes: a systematic review and meta-analysis

Evidence supporting the use of apps for lifestyle behavior change and diabetes prevention in people at high risk of diabetes is lacking. The aim of this systematic review was to determine the acceptability and effectiveness of smartphone applications (apps) for the prevention of type 2 diabetes. PubMed, Embase, CINAHL and PsychInfo were searched from 2008 to 2023. Included studies involved adults at high risk of developing diabetes evaluating an app intervention with the aim of preventing type 2 diabetes. Twenty-four studies (n=2378) were included in this systematic review, including nine randomized controlled trials (RCTs) with an average duration of 6 months, ten quasi-experimental and seven qualitative studies. Apps were effective at promoting weight loss and decreasing BMI, with no effect on glycated haemoglobin and waist circumference. The study concluded that smartphone apps have a promising effect on preventing type 2 diabetes by supporting weight loss. Future robust trials should include diverse populations in co-design and evaluation of apps and explore the role of artificial intelligence in further personalizing interventions for higher engagement and effectiveness.

CLINICAL STUDY

#mobile app

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Jan 19,2024

‘Smart speaker’ shows potential for better self-management of Type 2 diabetes

Researchers from Stanford Medicine have created a voice-based artificial intelligence application that runs on a device already familiar to tens of millions of Americans: a “smart speaker,” commonly used to play music and check the weather. The app tells patients the correct insulin dose without requiring them to contact their doctor’s office or wait for an appointment. Participants in a randomized trial who used the system achieved optimal blood glucose levels far faster than the control group; they were also better about taking the prescribed amount of insulin at the time they were supposed to. The study followed 32 individuals with Type 2 diabetes who were all taking insulin and struggling to achieve healthy blood glucose levels. Half of those received a speaker preloaded with the voice-based artificial intelligence software created by the research team. Each participant’s insulin protocol — including starting insulin dose, fasting blood glucose range goal and insulin dose instructions — was included in the software on their device. At the end of the conversation, the software provided updated instructions by responding, for example, “OK, keep doing what you’re doing,” or “Up your dose” by a specified amount. The platform goes beyond remote monitoring by enabling remote patient intervention for the first time, the researchers said. Over the eight-week study period, 81% of patients in the group who used the app achieved glycemic control of their diabetes compared with 25% of patients who received traditional care. Patients in the trial managed by the AI had their insulin dose adjusted more frequently and needed far fewer doctor’s appointments to get their diabetes under control.

CLINICAL STUDY

#ai/software

#mobile app

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Jan 25,2024

Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

Patients with diabetes and end-stage kidney disease (ESKD) may experience “burnt-out diabetes,” defined as having an HbA1c value <6.5% without antidiabetic therapy for >6 months. The research aims to assess glycemic control by continuous glucose monitoring (Dexcom G6 CGM) metrics and glycemic markers in ESKD patients on hemodialysis with burnt-out diabetes. In this pilot prospective study, glycemic control was assessed by continuous glucose monitoring (CGM), HbA1c measures, and glycated albumin and fructosamine measurements in patients with burnt-out diabetes (n = 20) and without a history of diabetes (n = 20). Patients with burnt-out diabetes had higher CGM-measured daily glucose levels, lower percent time in the range 70–180 mg/dL, higher percent time above range (>250 mg/dL), and longer duration of hyperglycemia >180 mg/dL (hours/day) compared with patients without diabetes. The use of CGM demonstrated that patients with burnt-out diabetes have significant undiagnosed hyperglycemia. CGM and glycated albumin provide better assessment of glycemic control than do values of HbA1c and fructosamine in patients with ESKD.

CLINICAL STUDY

#cgm

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Jan 24,2024 TOP STORY

Abbott Reports Fourth-Quarter and Full-Year 2023 Results; Issues 2024 Financial Outlook

Abbott announced financial results for the fourth quarter ended Dec. 31, 2023. The company's Q4 2023 sales increased 1.5% on a reported basis, 2.1% on an organic basis, and 11% percent on an organic basis, excluding COVID-19 testing-related sales. In Diabetes Care, FreeStyle Libre sales were $1.4 billion, which represents sales growth of 25.5 percent on a reported basis and 23.8 percent on an organic basis. Abbott's full year 2023 Diabetes Care revenue reached to $5.7 billion.

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