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 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). 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). Better Therapeutics' ongoing clinical studies are designed to assess the long-term effectiveness of AspyreRx in diverse populations, as measured by change in HbA1c, and safety, as measured by severity and frequency of adverse events. 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. This initial readout is expected to be followed by additional data releases in 2024.

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Sep 28,2023 TOP STORY

GAIA's New Depression Therapy for MS Shows Significant Results

In the study published in Lancet Digital Health, GAIA’s (digital) depression therapy “amiria” was able to show that it can significantly reduce depression symptoms and that the positive therapy effects were even detectable up to 1 year after the end of therapy. This parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. he dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group. The approval of amiria for the treatment of depression in MS patients in Germany (BfArM) is currently being prepared.

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Aug 24,2023

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study

Digital health programs that incorporate frequent blood pressure (BP) self-monitoring and support for behavior change offer a scalable solution for hypertension management. The study examined the impact of a digital hypertension self-management and lifestyle change support program provided by Omada Health over 12 months. Data were analyzed from a retrospective observational cohort of commercially insured members (n=1117) that started the Omada for Hypertension program between January 1, 2019, and September 30, 2021. At 12 months, all members (including members with controlled and uncontrolled BP at baseline) and those with uncontrolled systolic BP at baseline experienced significant mean reductions in SBP (mean -4.8 mm Hg). Members with uncontrolled systolic BP at baseline also had significant reductions in diastolic blood pressure (-4.7 mm Hg), weight (-6.5 lbs), and BMI (-1.1 kg/m2). Those with controlled Systolic BP at baseline maintained within BP goal range. Additionally, 48% (418/860) of members with uncontrolled BP at baseline experienced enough change in BP to improve their BP category.

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Sep 27,2023 TOP STORY

Dario Publishes New Research Demonstrating Clinically Significant Reductions in Depression Through its Digital Behavioral Health Programs

DarioHealth announced new research published in the Journal of Medical Internet Research (JMIR) demonstrating the impact of coaching and breathing exercises as part of the Dario digital behavioral health program alongside coaching and breathing exercises for members living with depression or anxiety. The study ''Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety: Retrospective, 2-Cohort, Real-World Analysis'' analyzed the data of participants in two cohorts engaged in Dario's digital self-guided programs who started at a moderate or high level of depression or anxiety. These study participants engaged in Dario's digital programs alongside the use of a coach or digitally-delivered breathing exercises over the course of 16 weeks to understand the impact of these support mechanisms. The analysis revealed a significant decrease in depression and anxiety symptoms during the first six weeks which was maintained throughout the rest of the 16 weeks program. 63% of members using Dario to manage depression experienced an overall improvement in symptoms, and the use of coaching support significantly moderated symptoms in the first six weeks.

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Jul 26,2019

A Digital Diabetes Prevention Program (Transform) for Adults With Prediabetes: Secondary Analysis

This study aimed to investigate the effects of a novel digital therapeutic diabetes prevention program (DPP) (Transform) on weight loss, body mass index (BMI), exercise frequency, and work absenteeism. It was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in the Transform DPP from December 2016 to December 2017. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. The sample (N=273) comprised people with prediabetes who completed 4 months of the Transform program. On average, participants increased their exercise frequency by 1.7 days per week, and absenteeism was reduced by almost half a day per month. These results suggest that the digital therapeutic DPP (Transform) is effective at preventing type 2 diabetes through a significant reduction in body weight and an increase of physical activity. A prospective, controlled clinical study is warranted to validate these findings.

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Sep 26,2023 TOP STORY

Senseonics Announces the Last Patient Completion of the 365-Day ENHANCE Pivotal Clinical Study

Senseonics, a medical technology company focused on the development of implantable continuous glucose monitoring (CGM) systems, today announced the completion of the ENHANCE Pivotal Clinical Study adult cohort following the recently completed 365-day visit for the final study patient. The ENHANCE study is designed to evaluate the accuracy and safety of the Eversense system for one year. Over 165 adult subjects were inserted with Eversense systems in four centers across the United States. Data gathered in this study was also used to support the FDA submission for the integrated continuous glucose monitoring, iCGM, designation earlier in 2023. An investigational device exemption (“IDE”) supplement was submitted and approved for expansion of the study to allow for pediatric patients 14 to 18 years of age and the first pediatric study participants were enrolled in Q2 2023.

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Jan 14,2022

A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis

The aim of this study is to investigate the effects of a digital Ddiabetes Prevention Program (DPP) (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. The results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. 

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Jan 14,2022

A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis

The aim of this study is to investigate the effects of a digital Ddiabetes Prevention Program (DPP) (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. The results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. 

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Aug 11,2023

Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study

This study explored the impact of switching to hybrid closed-loop (HCL) insulin delivery systems in adults with type 1 diabetes who had elevated HbA1c levels despite using intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. They conducted an observational study involving 570 HCL users across 31 diabetes centers in England. This study demonstrates that HCL insulin delivery systems can lead to significant improvements in glycemic control, reduced hypoglycemia, enhanced quality of life, and high patient satisfaction among adults with type 1 diabetes, even in real-world settings. The results showed significant improvements, including: The mean adjusted HbA1c decreased by 1.7% after switching to HCL, and TIR (glucose levels between 70–180 mg/dL) increased from 34.2% to 61.9%.

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Aug 10,2023

Real-world Accuracy of CGM in Inpatient Critical and Noncritical Care Settings at a Safety-Net Hospital

The study aimed to assess the real-world accuracy of inpatient continuous glucose monitoring (CGM) at various levels of patient acuity in a large safety-net hospital. The research involved analyzing data from hospitalized patients who used Dexcom G6 CGM devices, comparing CGM glucose readings with both point of care (POC) and laboratory (Lab) glucose measurements. The patients were categorized as not critically ill (NCI) or critically ill (CI). The study found that CGM accuracy was acceptable in both NCI and CI patients, with the accuracy being slightly better when compared to Lab glucose readings than POC readings. The analysis also revealed that certain unique patient conditions, such as anorexia nervosa, hypoglycemia disorders, and specific medical interventions, could affect CGM accuracy. Overall, the study suggests that inpatient CGM can be a valuable tool for glucose management, especially when used in a critical care setting, but further research is needed to explore its limitations and benefits in real-world scenarios.

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