Feb 08,2024

MedRhythms Announces Key Publications Confirming Efficacy, Safety, and Usability of InTandem™ for Chronic Stroke Walking Impairment

MedRhythms has announced the publication of two studies validating the efficacy, safety, and usability of InTandem™, an FDA-authorized, prescription-only neurorehabilitation system designed for home use to enhance walking and ambulation in adults with chronic stroke. The multi-site randomized controlled trial, published in Nature Communications, demonstrated the clinical benefits and safety of InTandem, while the usability study, published in JMIR Rehabilitation and Assistive Technologies, confirmed its safe and effective use in the home environment. The randomized controlled trial involved participants completing three 30-minute walking sessions weekly for five weeks. InTandem users showed statistically significant increases in walking speed compared to an active control group. Additionally, 48% of InTandem users transitioned from limited ambulators to community ambulators. Also, the summative usability study reported that 93% of adult chronic stroke participants could complete tasks associated with using InTandem at home, with no adverse events.

CLINICAL STUDY

#connected device

#pdt

View Analyst & Ambassador Comments
Go to original news
Feb 01,2024

Impact of digital assistive technologies on the quality of life for people with dementia: a scoping review

This scoping review aimed to explore the impact of Digital Assistive Technologies (DATs) on the quality of life (QOL) for people with dementia (PWD). The study conducted a comprehensive review of the literature from January 2013 to May 2023, utilizing databases such as Cochrane, Embase, PubMed, Scopus, and Web of Science. A total of 122 studies were included in the analysis, covering various types of DATs. The DATs were categorized into digital therapeutics (n=109), patient monitoring (n=30), digital diagnostics (n=2), care support (n=2), and health system clinical software (n=1). Digital therapeutics, in particular, were noted for their role in supporting aging-in-place and independent living by assisting with daily tasks. The study suggests that future research should focus on less-explored digital health technology categories, such as care support, health and wellness, or software solutions.

CLINICAL STUDY
View Analyst & Ambassador Comments
Go to original news
Feb 08,2024

A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting

Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycemic control and patient-reported outcomes in type 1 diabetes. The aim was to analyze the outcomes of two commercially available AHCL in real life. A prospective study was performed, including adolescents and adults with type 1 diabetes, AHCL naïve, from 14 centers, who initiated the use of MiniMed 780G with SmartGuard or Tandem t:slimX2 with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70–180 mg/dL difference from beginning to end of follow-up. Time in range increased from 61.53 to 76.17 , with no between-group differences. HbA1c decreased by 0.56%, , from 7.43 to 6.88. in the MiniMed 780G group, and from 7.14 to 6.56 in the Control-IQ group. No superiority of one AHCL over the other regarding fear of hypoglycemia or quality of life was found. Improvement in diabetes-related distress was higher in Control-IQ users. Sleep quality was improved, without differences between systems. Experience with AHCL, evaluated by the INSPIRE measures, exceeded the expectations.

CLINICAL STUDY

#closed loop

View Analyst & Ambassador Comments
Go to original news
Feb 01,2024

AI can Predict Brain Cancer Patients' Survival

Researchers at King's College London have utilized artificial intelligence (AI) to predict the survival of adult patients with glioblastoma, a challenging brain cancer, within eight months after receiving radiotherapy. The deep learning model, trained on a dataset of 10,000s of brain cancer scans, demonstrated improved accuracy in predicting outcomes compared to traditional methods. The AI offers an immediate and accurate prediction from routine MRI scans, allowing clinicians to identify patients who may not benefit from chemotherapy, enabling a shift to alternative treatments or clinical trials. The study addresses the need for better outcomes in brain cancer patients and empowers individuals to make informed decisions about their treatment.

CLINICAL STUDY

#ai/software

View Analyst & Ambassador Comments
Go to original news
Feb 01,2024 TOP STORY

Long Term Results of a Digital Type 2 Diabetes Program from Omada Health

A new study from Omada Health aimed to examine the long-term impact of a digital diabetes self-management education and support (DSMES) program on A1C among adults with type 2 diabetes (T2DM). Data analyzed were from a retrospective cohort of commercially insured members with T2DM enrolled in the Omada for Diabetes program between January 1, 2019, and January 31, 2022 (n=1,322). The study measured changes in A1C and weight across 12?months (collected at baseline and every 3 months over 1 year) overall and stratified by A1C at baseline (8% vs <8%). The results showed a real-world evidence that members with elevated baseline A1C (8%) enrolled in a digital DSMES program experienced clinically meaningful and statistically significant reductions in A1C. Members with baseline A1C 8% demonstrated clinically and statistically significant adjusted mean reductions in A1C during follow-up, from 9.48% at baseline to 7.33%, 7.57%, 7.59%, and 7.47% at 3, 6, 9, and 12 months, respectively. Those with A1C <8% maintained glycemic stability. Collectively, members experienced a 1.17kg/m2 mean reduction in BMI over 12 months.

CLINICAL STUDY
View Analyst & Ambassador Comments
Go to original news
Feb 01,2024

Evidence From First Mahana Tinnitus Study Accepted for Presentation at Upcoming American Audiology Society (AAS) Annual Meeting

Mahana Therapeutics, a leading provider of digital therapeutics, announced that positive results from a large US-based Pilot Clinical Trial, have been accepted for presentation at the upcoming American Audiology Society (AAS) Scientific and Technology Meeting, on February 15-17, 2024 in Scottsdale, Arizona. The pilot study, one of the largest US-based of its kind with 97 participants, explored the acceptability, safety, and clinical outcomes of Mahana Tinnitus™, which provides Digital Cognitive Behavioral Therapy (CBT) for adults with bothersome tinnitus. Key results from the abstract now available online include: 61% of participants in the Intent To Treat (ITT) population experienced a clinically meaningful improvement in TFI score after 6 weeks, and 65% reported a global impression of change, with improvements reported across tinnitus-related domains, like sleep, distress, and coping.

CLINICAL STUDY

#cbt

View Analyst & Ambassador Comments
Go to original news
Feb 01,2024

Long Term Results of a Digital Type 2 Diabetes Program from Omada Health

A new study from Omada Health aimed to examine the long-term impact of a digital diabetes self-management education and support (DSMES) program on A1C among adults with type 2 diabetes (T2DM). Data analyzed were from a retrospective cohort of commercially insured members with T2DM enrolled in the Omada for Diabetes program between January 1, 2019, and January 31, 2022 (n=1,322). The study measured changes in A1C and weight across 12?months (collected at baseline and every 3 months over 1 year) overall and stratified by A1C at baseline (8% vs <8%). The results showed a real-world evidence that members with elevated baseline A1C (8%) enrolled in a digital DSMES program experienced clinically meaningful and statistically significant reductions in A1C. Members with baseline A1C 8% demonstrated clinically and statistically significant adjusted mean reductions in A1C during follow-up, from 9.48% at baseline to 7.33%, 7.57%, 7.59%, and 7.47% at 3, 6, 9, and 12 months, respectively. Those with A1C <8% maintained glycemic stability. Collectively, members experienced a 1.17kg/m2 mean reduction in BMI over 12 months.

CLINICAL STUDY
View Analyst & Ambassador Comments
Go to original news
Jan 23,2024

Cognito Therapeutics Announces First Patient Enrolled in HOPE Biomarker Study

Cognito Therapeutics, a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced the first patient enrolled in a biomarker substudy within the HOPE pivotal trial. The HOPE study is evaluating a novel disease-modifying therapy that elicits gamma frequency brain activity through non-invasive sensory stimulation and has the potential to slow the progression of Alzheimer’s Disease, from the comfort of a patient’s home. “The enrollment of the first patient in the HOPE biomarker substudy is a clinical milestone for our company. We are on track to achieve study completion within our projected timelines, with over 240 patients currently enrolled in the HOPE study across 60 active sites across the US,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics.

CLINICAL STUDY

#connected device

View Analyst & Ambassador Comments
Go to original news
Dec 11,2023

Cognito Therapeutics Phase 2 OVERTURE Study MRI Imaging Analysis Published in Journal of Alzheimer’s Disease

Cognito Therapeutics, a neurotechnology company developing disease-modifying therapies for neurodegenerative diseases, announced today publication of MRI imaging data from its Phase 2 OVERTURE study in the Journal of Alzheimer’s Disease. Cognito therapy employs a proprietary non-invasive approach to induce increased gamma frequency brain activity via specific frequencies of auditory and visual neuromodulation. The paper, titled: “Noninvasive gamma sensory stimulation may reduce white matter and myelin loss in Alzheimer’s Disease,” reported that patients with mild-moderate Alzheimer’s Disease (AD) who received one-hour daily treatment with Cognito’s gamma sensory device over 6 months showed reduced white matter atrophy and preserved brain myelin content compared to sham treatment in the Phase 2 OVERTURE study.

CLINICAL STUDY

#connected device

View Analyst & Ambassador Comments
Go to original news
Jan 22,2024

Development and pre-pilot testing of STAMP+CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain

The researchers have developed and piloted a mobile health the STAMP+CBT app to deliver cognitive behavioral therapy for pain (pain-CBT), remote symptom monitoring, and pharmacologic support for patients with pain from advanced cancer. The app delivers brief daily lessons from pain-CBT and pain psychoeducation, adapted for advanced cancer. Daily surveys assess physical symptoms, psychological symptoms, opioid utilization and relief. Just-in-time adaptive interventions generate tailored psychoeducation in response. They then conducted a single-arm pilot feasibility study at two cancer centers. Patients with advanced cancer and chronic pain used the app for 2 or 4 weeks, rated its acceptability and provided feedback in semi-structured interviews. Fifteen participants tested the app. Feasibility and acceptability were defined as 70% of participants completing 50% of daily surveys, and 80% of acceptability items rated 4/5. The results showed 73% of patients completed 50% of daily surveys; 87% of acceptability items were rated 4/5. Participants valued the app’s brevity, clarity, and salience, and found education on stress and pain to be most helpful.

CLINICAL STUDY

#mobile app

View Analyst & Ambassador Comments
Go to original news
Subscribe to CLINICAL STUDY