Oct 11,2023 TOP STORY

Better Therapeutics Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes

Better Therapeutics announced new findings from a recent subgroup analysis of AspyreRx (formerly BT-001) in its pivotal trial for type 2 diabetes (T2D). The analysis reveals that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonists (GLP-1), leads to a substantially greater clinical improvement compared to control participants who did not incorporate AspyreRx into their regimen. The subgroup analysis, involving approximately 160 participants on GLP-1s randomized to the active and control arm of the study, exhibited an average reduction in HbA1c of 0.7% at 90 days, between the two groups. This exceeds the results of the entire BT-001 pivotal trial population, where AspyreRx outperformed the standard of care control arm by 0.4%. The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled 'Regulatory Considerations for Prescription Drug Use-Related Software,' released in September, which provides clarity about the agency’s views and intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions.

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#dtx

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Oct 06,2023

Curio Digital Therapeutics: Pivotal Trial for Postpartum Depression Digital Therapeutic Meets Efficacy Endpoints

Curio Digital Therapeutics today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial. SuMMER is a national, randomized, placebo (sham)-controlled pivotal trial evaluating MamaLift Plus for eight weeks in 141 patients (ITT population) randomized in a 2:1 ratio to the MamaLift Plus arm (N = 95) and control (sham digital) arm (N = 46). The SuMMER trial met its primary endpoint, a ?4-point improvement in Edinburgh Postnatal Depression Scale (EPDS) score. Preliminary results indicate that approximately 83% of participants in the intervention arm achieved a 4-point improvement in EPDS score, compared to only 22% in the control arm. Approximately 82% of patients in the intervention arm achieved an EPDS reduction to <13, compared to only 30% in the control arm.

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#cbt

#coaching

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Oct 06,2023

PFD Week Abstracts Show Leva’s Long-Term Treatment Value for Female Urinary Incontinence Plus New Data for Other Pelvic Floor Disorders

Axena Health, a medical device company focused on female pelvic health, commends leading researchers in women’s health, who presented data showing that urinary incontinence (UI) symptom relief is durable for two-years following eight-weeks of treatment with the Leva® Pelvic Health System. These researchers also presented data showing that the Leva System improved symptoms of early-stage pelvic organ prolapse, a pelvic floor disorder in which one or more of the pelvic organs drop or press into or out of the vagina due to a weak pelvic floor. The Leva System is a non-drug, non-surgical treatment that helps women strengthen their pelvic floor at home, on their own schedule, by guiding correct and consistent pelvic floor muscle training (PFMT).

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#connected device

#mobile app

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Oct 05,2023

Better Therapeutics Announces Publication of LivVita Liver Disease Study Results in Gastro Hep Advances

Better Therapeutics today announced the pre-print publication of the LivVita study's results in Gastro Hep Advances. The feasibility study's authors conclude that the positive efficacy, safety, and usability data underscore the potential of Better Therapeutics' digitally delivered Cognitive Behavioral Therapy (CBT) to address the unmet clinical needs associated with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. This first-of-kind study (n=22) demonstrated improvements in multiple markers, including MRI-PDFF, FibroScan CAP score, weight, FastTM score, and ALT, suggesting therapeutic potential in a larger patient population. Additionally, there were no device-related adverse events, even in patients with a large number of comorbidities and background pharmacotherapy use. The company anticipates submitting a request to the FDA for Breakthrough Device Designation by the end of 2023.

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#cbt

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Oct 04,2023

New Data from Phase 3 Trial Further Validate Prognostic Value of Veracyte’s Decipher Prostate Genomic Classifier

Veracyte announced that new data from a large, randomized phase 3 trial reinforce the value of the Decipher Prostate Genomic Classifier in helping physicians make more informed treatment decisions for their patients with prostate cancer. The findings, presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, suggest that the Decipher Prostate test can categorize more accurately risk of patients with clinically high-risk disease to help inform appropriate treatment. In the first study, the Decipher Prostate test proved effective in predicting outcomes independently associated with metastasis-free survival and distant metastasis for high-risk prostate cancer patients receiving radiation and therapy, outperforming standard risk factors including Gleason score, T-stage and prostate-specific antigen. The second study found minimal to moderate correlation between three gene expression signature tests, including Decipher Prostate, indicating they should not be used interchangeably, and clinicians should rely on evidence-based decision-making for each test.

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#ai/software

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Oct 02,2023 TOP STORY

Dexcom Solidifies Global Leadership in Continuous Glucose Monitoring With New Clinical Data Presented at EASD

Dexcom announced new clinical study outcomes that further demonstrate the benefits of CGM use and offered more details about its expanding portfolio of automated insulin delivery offerings at the 59th Annual Meeting of the European Association for the Study of Diabetes held Oct. 2-6, 2023 in Hamburg, Germany. New results from the COMISAIR seven-year study, the longest prospective real-world CGM study ever conducted, show significant and continued reduction of HbA1c with the use of real-time CGM by people with Type 1 diabetes. Regardless of insulin delivery method, multiple daily injections or insulin pump therapy, real-time CGM has greater and statistically significant HbA1c reduction when compared to self-monitoring blood glucose over seven years. The COMISAIR study also shows further substantial reduction in HbA1c when real-time CGM is connected to an automated insulin delivery system, specifically Tandem Control IQ. Dexcom announced the Dexcom G7 CGM system will begin launching with the Tandem t:slim X2 insulin pump before the end of the year in the U.S. and multiple markets across Europe and Asia-Pacific. This news follows the recent launch of the Omnipod 5 Automated Insulin Delivery System connected to Dexcom G6 in the UK and Germany.

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#cgm

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Sep 27,2023

Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial

Biliopancreatic disorders are quite common and involve a whole spectrum of diseases from mild to severe, including pancreatic cancers. The study aimed to assess the performance of an updated AI device called EUS-IREAD in improving the quality of endoscopic ultrasonography (EUS) procedures for diagnosing biliopancreatic diseases. EUS is essential for diagnosis but can vary in performance among endoscopists, leading to blind spots and potentially impacting patient outcomes. The study involved 290 patients with suspected biliopancreatic lesions who were randomly assigned to undergo EUS with or without EUS-IREAD assistance. Results showed that the EUS-IREAD-assisted group had a significantly lower missed scanning rate of standard stations compared to the control group (4.5% vs. 14.3%).

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#ai/software

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Sep 28,2023

New Data Presented at the 2023 ATA Annual Meeting Demonstrate that Veracyte’s Afirma-Based Testing Can Uncover Key Molecular Hallmarks of Thyroid Cancer

Veracyte, Inc. has unveiled groundbreaking data at the 2023 American Thyroid Association Annual Meeting, showcasing novel molecular insights into thyroid nodules and cancer made possible by their Afirma Genomic Sequencing Classifier (GSC). Researchers presented findings based on Afirma whole-transcriptome RNA sequencing data, which offer fresh perspectives for advancing thyroid nodule and cancer research. These insights can be explored using Veracyte's Afirma Genomic Resource for Intelligent Discovery (GRID) tool, available for research purposes. The presented data highlight the potential for personalized, whole-transcriptome-based insights in understanding thyroid nodules and cancer's molecular basis. Additionally, they introduce the Afirma GRID tool, which promises to facilitate novel discoveries in this field. The Afirma GRID tool aims to provide comprehensive molecular profiles for thyroid cancer research, fostering a more personalized approach to diagnosis and treatment.

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#ai/software

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Sep 28,2023 TOP STORY

Better Therapeutics Completes Enrollment in Real-World Evidence Program Evaluating Long-term Effectiveness of AspyreRx in Type 2 Diabetes

Better Therapeutics today announced it has completed the enrollment of 1,000 participants across two studies as part of its ongoing clinical program to evaluate the long-term effectiveness of AspyreRxTM (formerly BT-001), as measured by change in HbA1c, and safety, as measured by severity and frequency of adverse events. AspyreRx received FDA authorization in July 2023 as the first PDT to deliver Cognitive Behavioral Therapy (CBT) to treat adults with type 2 diabetes (T2D). The impact on medication use and healthcare utilization one year after beginning treatment with AspyreRx will also be evaluated, along with an advanced understanding of patient engagement patterns in a real-world setting. Depending on adequate power, Better Therapeutics plans to share initial 6-month data by the end of 2023.

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#pdt

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Sep 29,2023

Leveraging Digital Health Platforms To Improve Outcomes in Respiratory Care: Insights From ERS 2023

Propeller Health and ResMed explored the impact of digital health platforms in respiratory care at the 2023 European Respiratory Society (ERS) International Congress. One study showed that combining a virtual clinical care team with Propeller's digital self-management platform led to enhanced clinical outcomes and program retention in asthma management, emphasizing the value of a hybrid digital and clinical approach. Another study conducted in the UK demonstrated the effectiveness of Propeller's digital platform in promoting medication adherence among patients with severe asthma, resulting in improved asthma control, quality of life, and healthcare utilization, underscoring the significance of digital platforms in managing severe asthma.

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#virtual care

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