Oct 30,2023

Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study

This single-center, randomized, crossover study evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults (n=26) with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order. In an intention-to-treat analysis, the proportion of time glucose was in range was higher during closed-loop than during pump with CGM. In conclusin, fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.

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#closed loop

#insulin pump

#cgm

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Oct 24,2023

Positive Real World Evidence of Mahana IBS Presented at the American College of Gastroenterology (ACG) Annual 2023 Scientific Meeting

Mahana Therapeutics announced the results from the analysis presented by Mythili Pathipati, M.D. of Mass General Hospital at ACG 2023 Scientific Meeting in Vancouver on October 24, 2023 demonstrating that nearly 60% of users who completed Mahana IBS in the real world setting reported clinically meaningful reduction in severity of IBS symptoms. The real world analysis evaluated results from 843 patients using Mahana IBS over a 2-year timeframe from August 2021 to August 2023. In addition to evaluating IBS symptom severity and anxiety, the real world analysis assessed factors associated with adherence and response to Mahana IBS. Key results from the Real World Analysis include: 38% (n=324) of subjects were adherent as defined by completion of the first five sessions of the program, and statistically significant reductions in pain, bloating and IBS interference and improvements in bowel satisfaction were observed.

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#pdt

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Oct 25,2023 TOP STORY

New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine

Theranica, a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio®, a Remote Electrical Neuromodulation (REN) device for the treatment of migraine. The study included 409 participants across the entire USA who used Nerivio device for acute treatment of migraine for 12 consecutive months, reporting their data prospectively. The results showed consistent and persistent efficacy in pain relief, pain freedom, functional disability relief, and functional disability freedom, as well as consistent adherence. The non-disruptive nature of using Nerivio is designed to promote high adherence: the device can be worn under a shirt or jacket sleeve, and is self-controlled through a user-friendly smartphone app, making it ideal for discreet usage even in places that are not private, like a school class, a work office, or on a bus or a train.

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#connected device

#mobile app

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Oct 16,2023

ArteraAI Validates its Prognostic Model in Advanced Prostate Cancer

ArteraAI, the developer of multimodal artificial intelligence (MMAI) based predictive and prognostic cancer tests, announces new data that will be presented at the European Society for Medical Oncology’s (ESMO) Congress Oct. 20-24. These data demonstrate successful validation of ArteraAI’s prognostic model in advanced prostate cancer with stronger prognostic associations than individual clinical variables. Moreover, the model was also able to identify pathologic features from the biopsy slide images that were strongly associated with poor prognosis in prostate biopsies from high-risk localized (M0) and metastatic (M1) prostate cancer. The validation was conducted using final data from a number of STAMPEDE trials (NCT00268476). In this study, an MMAI prognostic model that was developed using digitized whole scan images from new prostate biopsies along with other clinical data such as Gleason scores, tumor stage, and PSA levels was used to determine long-term, clinically relevant outcomes, as defined in STAMPEDE

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#ai/software

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Oct 05,2023

An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia

Click Therapeutics, and Boehringer Ingelheim as the collaborator, registered an open label extension, randomized phase 3 trial to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05853900. The study aims to enroll 216 late adolescents and adults who completed participation in NCT05853900 (Week 20) study within 7 days of the extension study Baseline Visit (Day 1). The primary outcome measure is the change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).

CLINICAL STUDY

#pdt

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Oct 20,2023

Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)

GAIA Group has registered a new study aiming to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (MS). Therefore, 470 people with MS will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (TAU) (n = 235) and (2) a control group receiving an overview of relevant brochures from the German Multiple Sclerosis Society on the topic of lifestyle in MS in addition to TAU (n = 235).The primary outcome measure is the total score on the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS), collected 6 months post-randomization. The study is still not recruiting, and planned to start in the following days.

CLINICAL STUDY

#pdt

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Oct 19,2023

Newel Health Registered a New Interventional Study for Management of Hypertension

Newel Health is aiming to start the multicenter randomized study beginning of November 2023 to investigate the long-term efficacy of the Amicomed Digital Therapeutics Program, compared to Usual Care, in reducing Systolic and Diastolic Blood Pressure in subjects with primary hypertension. Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include: an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels; generating and delivering a detailed lifestyle program; and a behavioral strategy embedded into the app to increase adherence and persistence into the program.

CLINICAL STUDY

#mobile app

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Oct 17,2023 TOP STORY

Immersive Virtual Reality Seems to Ease Cancer Patients' Pain and Distress

Immersive virtual reality - digital technology that allows a person to experience being physically present in a non-physical world - seems to ease the pain and distress felt by patients with cancer, suggests a pooled data analysis of the available evidence published in BMJ Supportive & Palliative Care. The researchers trawled research databases for studies that looked at the use and effectiveness of immersive virtual reality for aiding psychological adjustment to a long term condition in adults. They found 31 relevant studies, published between 1993 and 2023, in which the technology had been used in patients with cancer (16), dementia (5), cardiovascular disease (4), MS (2), kidney disease (2), inflammatory bowel disease (1), and chronic obstructive pulmonary disease (1). Pooling the study results showed that patients were happy to use immersive virtual reality and that it helped those with cancer, dementia, cardiovascular disease, MS and kidney disease cope better with required medical treatments and the emotional impact of their condition. The types of virtual reality and procedures used varied widely across the included studies, and no one particular type emerged as noticeably more effective than any of the others.

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#virtual reality

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Oct 17,2023 TOP STORY

New Research Shows 36% Reduction in 30-Day Hospital Readmission Rate for Dario Users with Type 2 Diabetes

DarioHealth announced today new research presented by Sanofi U.S. at the Academy of Managed Care Pharmacy's 2023 annual conference Nexus, demonstrating a 36% reduction in 30-day hospital readmissions for Dario users compared to non-users living with type 2 diabetes. New data presented by Sanofi U.S. at AMCP-Nexus examined matched Dario users and non-users with type 2 diabetes to understand the impact of Dario's digital health solution. The research examined real-world claims data to determine whether users engaged with Dario's solution demonstrated less costly utilization of hospital-related utilization and found 36% reduction in 30-day hospital readmission rate; and 1.6 fewer days in the hospital. The research is part of an ongoing study initiative conducted jointly by Dario and Sanofi U.S., and complements previously published studies presented at ISPOR demonstrating Dario's ability to reduce all-cause healthcare utilization by 9% and inpatient hospitalizations by 23%.

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#mobile app

#coaching

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Oct 17,2023 TOP STORY

New Research Shows 36% Reduction in 30-Day Hospital Readmission Rate for Dario Users with Type 2 Diabetes

DarioHealth announced today new research presented by Sanofi U.S. at the Academy of Managed Care Pharmacy's 2023 annual conference Nexus, demonstrating a 36% reduction in 30-day hospital readmissions for Dario users compared to non-users living with type 2 diabetes. New data presented by Sanofi U.S. at AMCP-Nexus examined matched Dario users and non-users with type 2 diabetes to understand the impact of Dario's digital health solution. The research examined real-world claims data to determine whether users engaged with Dario's solution demonstrated less costly utilization of hospital-related utilization and found 36% reduction in 30-day hospital readmission rate; and 1.6 fewer days in the hospital. The research is part of an ongoing study initiative conducted jointly by Dario and Sanofi U.S., and complements previously published studies presented at ISPOR demonstrating Dario's ability to reduce all-cause healthcare utilization by 9% and inpatient hospitalizations by 23%.

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#mobile app

#dtx

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