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Mimicking vaginal cells and microbiome interactions on chip microfluidic culture

Posted in Automated Cell Processing, Bio Instrumentation in Experimental Life Sciences Research, Biological Engineering, Biological Networks, Biotechnology, Cell Level, Clinical & Translational, Clinical Diagnostics, Diagnostics and Lab Tests, Medical Device Therapies for Altzheimer’s Disease, Microbiology, MicroEngineering Cell-Tissue & Systems, Microfuidics, Mobile Healthcare, Organ-on-a-Chip, Patient-centered Medicine, Personal Health Applications: Tech Innovations serves HealhCare, Personalized and Precision Medicine & Genomic Research, Population Health Management, Population Health Management, Genetics & Pharmaceutical, Reproductive Andrology, Embryology, Genomic Endocrinology, Preimplantation Genetic Diagnosis and Reproductive Genomics, Reproductive Biology & Bio Instrumentation, Signaling, Tissue Engineering, Women Health, tagged artificial vagina, reproduction, reproductive health, reproductive medicine, reproductive research, reproductive toxicology on February 14, 2023| Leave a Comment »

Mimicking vaginal cells and microbiome interactions on chip microfluidic culture

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

Scientists at Harvard University’s Wyss Institute for Biologically Inspired Engineering have developed the world’s first “vagina-on-a-chip,” which uses living cells and bacteria to mimic the microbial environment of the human vagina. It could help to test drugs against bacterial vaginosis, a common microbial imbalance that makes millions of people more susceptible to sexually transmitted diseases and puts them at risk of preterm delivery when pregnant. Vaginal health is difficult to study in a laboratory setting partly because laboratory animals have “totally different microbiomes” than humans. To address this, scientists have created an unique chip, which is an inch-long, rectangular polymer case containing live human vaginal tissue from a donor and a flow of estrogen-carrying material to simulate vaginal mucus.

The organs-on-a-chip mimic real bodily function, making it easier to study diseases and test drugs. Previous examples include models of the lungs and the intestines. In this case, the tissue acts like that of a real vagina in some important ways. It even responds to changes in estrogen by adjusting the expression of certain genes. And it can grow a humanlike microbiome dominated by “good” or “bad” bacteria. The researchers have demonstrated that Lactobacilli growing on the chip’s tissue help to maintain a low pH by producing lactic acid. Conversely, if the researchers introduce Gardnerella, the chip develops a higher pH, cell damage and increased inflammation: classic bacterial vaginosis signs. So, the chip can demonstrate how a healthy / unhealthy microbiome affects the vagina.

The next step is personalization or subject specific culture from individuals. The chip is a real leap forward, it has the prospect of testing how typical antibiotic treatments against bacterial vaginosis affect the different bacterial strains. Critics of organ-on-a-chip technology often raise the point that it models organs in isolation from the rest of the body. There are limitations such as many researchers are interested in vaginal microbiome changes that occur during pregnancy because of the link between bacterial vaginosis and labor complications. Although the chip’s tissue responds to estrogen, but it does not fully mimic pregnancy without feedback loops from other organs. The researchers are already working on connecting the vagina chip to a cervix chip, which could better represent the larger reproductive system.

All these information indicate that the human vagina chip offers a new model to study host-vaginal microbiome interactions in both optimal and non-optimal states, as well as providing a human relevant preclinical model for development and testing of reproductive therapeutics, including live bio-therapeutics products for bacterial vaginosis. This microfluidic human vagina chip that enables flow through an open epithelial lumen also offers a unique advantage for studies on the effect of cervicovaginal mucus on vaginal health as clinical mucus samples or commercially available mucins can be flowed through this channel. The role of resident and circulating immune cells in host-microbiome interactions also can be explored by incorporating these cells into the vagina chip in the future, as this has been successfully done in various other organ chip models.

References:

https://www.scientificamerican.com/article/first-vagina-on-a-chip-will-help-researchers-test-drugs/

https://www.webmd.com/infertility-and-reproduction/news/20230209/scientists-create-vagina-on-chip-what-to-know

https://www.livescience.com/vagina-on-a-chip

https://link.springer.com/article/10.1186/s40168-022-01400-1

https://www.nature.com/articles/s41585-022-00717-8

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Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance

Posted in Artificial Intelligence in Health Care - Tools & Innovations, Artificial Pancreas for Type 2 Diabetes, Artificial Pancreas for Type1 Diabetes, Diabetes Mellitus, HealthCare IT, Medical Devices R&D and Inventions, Mobile Healthcare, tagged artificial pancreas, Blood sugar, dialysis, Hypoglycemia, kidney disease, Medical device, type 2 diabetes on August 13, 2021| Leave a Comment »

Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance

Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc

In a brief, randomized crossover investigation, adults with type 2 diabetes and end-stage renal disease who needed dialysis benefited from an artificial pancreas. Tests conducted by the University of Cambridge and Inselspital, University Hospital of Bern, Switzerland, reveal that now the device can help patients safely and effectively monitor their blood sugar levels and reduce the risk of low blood sugar levels.

Diabetes is the most prevalent cause of kidney failure, accounting for just under one-third (30%) of all cases. As the number of people living with type 2 diabetes rises, so does the number of people who require dialysis or a kidney transplant. Kidney failure raises the risk of hypoglycemia and hyperglycemia, or unusually low or high blood sugar levels, which can lead to problems ranging from dizziness to falls and even coma.

Diabetes management in adults with renal failure is difficult for both the patients and the healthcare practitioners. Many components of their therapy, including blood sugar level targets and medications, are poorly understood. Because most oral diabetes drugs are not indicated for these patients, insulin injections are the most often utilized diabetic therapy-yet establishing optimum insulin dose regimes is difficult.

A team from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust earlier developed an artificial pancreas with the goal of replacing insulin injections for type 1 diabetic patients. The team, collaborating with experts at Bern University Hospital and the University of Bern in Switzerland, demonstrated that the device may be used to help patients with type 2 diabetes and renal failure in a study published on 4 August 2021 in Nature Medicine.

The study’s lead author, Dr Charlotte Boughton of the Wellcome Trust-MRC Institute of Metabolic Science at the University of Cambridge, stated:

Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition-trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.

The Device

**Image Source: https://assets.medpagetoday.net/media/images/93xxx/93892.jpg**

The artificial pancreas is a compact, portable medical device that uses digital technology to automate insulin delivery to perform the role of a healthy pancreas in managing blood glucose levels. The system is worn on the outside of the body and consists of three functional components:

a glucose sensor
a computer algorithm for calculating the insulin dose
an insulin pump

The artificial pancreas directed insulin delivery on a Dana Diabecare RS pump using a Dexcom G6 transmitter linked to the Cambridge adaptive model predictive control algorithm, automatically administering faster-acting insulin aspart (Fiasp). The CamDiab CamAPS HX closed-loop app on an unlocked Android phone was used to manage the closed loop system, with a goal glucose of 126 mg/dL. The program calculated an insulin infusion rate based on the data from the G6 sensor every 8 to 12 minutes, which was then wirelessly routed to the insulin pump, with data automatically uploaded to the Diasend/Glooko data management platform.

The Case Study

Between October 2019 and November 2020, the team recruited 26 dialysis patients. Thirteen patients were randomly assigned to get the artificial pancreas first, followed by 13 patients who received normal insulin therapy initially. The researchers compared how long patients spent as outpatients in the target blood sugar range (5.6 to 10.0mmol/L) throughout a 20-day period.

Patients who used the artificial pancreas spent 53 % in the target range on average, compared to 38% who utilized the control treatment. When compared to the control therapy, this translated to approximately 3.5 more hours per day spent in the target range.

The artificial pancreas resulted in reduced mean blood sugar levels (10.1 vs. 11.6 mmol/L). The artificial pancreas cut the amount of time patients spent with potentially dangerously low blood sugar levels, known as ‘hypos.’

The artificial pancreas’ efficacy improved significantly over the research period as the algorithm evolved, and the time spent in the target blood sugar range climbed from 36% on day one to over 60% by the twentieth day. This conclusion emphasizes the need of employing an adaptive algorithm that can adapt to an individual’s fluctuating insulin requirements over time.

When asked if they would recommend the artificial pancreas to others, everyone who responded indicated they would. Nine out of ten (92%) said they spent less time controlling their diabetes with the artificial pancreas than they did during the control period, and a comparable amount (87%) said they were less concerned about their blood sugar levels when using it.

Other advantages of the artificial pancreas mentioned by study participants included fewer finger-prick blood sugar tests, less time spent managing their diabetes, resulting in more personal time and independence, and increased peace of mind and reassurance. One disadvantage was the pain of wearing the insulin pump and carrying the smartphone.

Professor Roman Hovorka, a senior author from the Wellcome Trust-MRC Institute of Metabolic Science, mentioned:

Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, but it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about the blood sugar levels, and more time getting on with their lives.

The team is currently testing the artificial pancreas in outpatient settings in persons with type 2 diabetes who do not require dialysis, as well as in difficult medical scenarios such as perioperative care.

“The artificial pancreas has the potential to become a fundamental part of integrated personalized care for people with complicated medical needs,” said Dr Lia Bally, who co-led the study in Bern.

The authors stated that the study’s shortcomings included a small sample size due to “Brexit-related study funding concerns and the COVID-19 epidemic.”

Boughton concluded:

We would like other clinicians to be aware that automated insulin delivery systems may be a safe and effective treatment option for people with type 2 diabetes and kidney failure in the future.

Main Source:

Boughton, C. K., Tripyla, A., Hartnell, S., Daly, A., Herzig, D., Wilinska, M. E., & Hovorka, R. (2021). Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nature Medicine, 1-6.

Other Related Articles published in this Open Access Online Scientific Journal include the following:

Developing Machine Learning Models for Prediction of Onset of Type-2 Diabetes

Reporter: Amandeep Kaur, B.Sc., M.Sc.

https://pharmaceuticalintelligence.com/2021/05/29/developing-machine-learning-models-for-prediction-of-onset-of-type-2-diabetes/

Artificial pancreas effectively controls type 1 diabetes in children age 6 and up

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2020/10/08/artificial-pancreas-effectively-controls-type-1-diabetes-in-children-age-6-and-up/

Google, Verily’s Uses AI to Screen for Diabetic Retinopathy

Reporter : Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/04/08/49900/

World’s first artificial pancreas

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/05/16/worlds-first-artificial-pancreas/

Artificial Pancreas – Medtronic Receives FDA Approval for World’s First Hybrid Closed Loop System for People with Type 1 Diabetes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/09/30/artificial-pancreas-medtronic-receives-fda-approval-for-worlds-first-hybrid-closed-loop-system-for-people-with-type-1-diabetes/

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This AI Just Evolved From Companion Robot To Home-Based Physician Helper

Posted in Artificial Intelligence - Breakthroughs in Theories and Technologies, Artificial Intelligence - General, Artificial Intelligence Applications in Health Care, Artificial Intelligence in Health Care - Tools & Innovations, Mobile Healthcare, Transformative Technologies in Healthcare, Voices of Patients and Healthcare Providers, tagged Artificial intelligence, Conditions and Diseases, ElliQ, healthcare, Intuition Robotics, Personalized medicine on July 6, 2021| Leave a Comment »

This AI Just Evolved From Companion Robot To Home-Based Physician Helper

Reporter: Ethan Coomber, Research Assistant III, Data Science and Podcast Library Development

Article Author: Gil Press Senior Contributor Enterprise & Cloud @Forbes

Twitter: @GilPress I write about technology, entrepreneurs and innovation.

Intuition Robotics announced today that it is expanding its mission of improving the lives of older adults to include enhancing their interactions with their physicians. The Israeli startup has developed the AI-based, award-winning proactive social robot ElliQ which has spent over 30,000 days in older adults’ homes over the past two years. Now ElliQ will help increase patient engagement while offering primary care providers continuous actionable data and insights for early detection and intervention.

https://thumbor.forbes.com/thumbor/960×0/https%3A%2F%2Fspecials-images.forbesimg.com%2Fimageserve%2F60dbd2bd8b6ee2d4c37afd01%2F960x0.jpg%3Ffit%3Dscale

The very big challenge Intuition Robotics set up to solve was to “understand how to create a relationship between a human and a machine,” says co-founder and CEO Dor Skuler. Unlike a number of unsuccessful high-profile social robots (e.g., Pepper) that tried to perform multiple functions in multiple settings, ElliQ has focused exclusively on older adults living alone. Understanding empathy and how to grow a trusting relationship were the key objectives of Intuition Robotics’ research project, as well as how to continuously learn the specific (and changing) behavioral characteristics, habits, and preferences of the older adults participating in the experiment.

The results are impressive: 90% of users engage with ElliQ every day, without deterioration in engagement over time. When ElliQ proactively initiates deep conversational interactions with its users, there’s 70% response rate. Most important, the participants share something personal with ElliQ almost every day. “She has picked up my attitude… she’s figured me out,” says Deanna Dezern, an ElliQ user who describes her robot companion as “my sister from another mother.”

Higher patient engagement leads to lower costs of delivering care and the quality of the physician-patient relationship is positively associated with improved functional health, studies have found. Typically, however, primary care physicians see their patients anywhere from once a month to once a year, even though about 85% of seniors in the U.S. have at least one chronic health condition. ElliQ, with the consent of its users, can provide data on the status of patients in between office visits and facilitate timely and consistent communications between physicians and their patients.

Supporting the notion of a home-based physician assistant robot is the transformation of healthcare delivery in the U.S. More and more primary care physicians are moving from a fee-for-service business model, where doctors are paid according to the procedures used to treat a patient, to “capitation,” where doctors are paid a set amount for each patient they see. This shift in how doctors are compensated is gaining momentum as a key solution for reducing the skyrocketing costs of healthcare: “…inadequate, unnecessary, uncoordinated, and inefficient care and suboptimal business processes eat up at least 35%—and maybe over 50%—of the more than $3 trillion that the country spends annually on health care. That suggests more than $1 trillion is being squandered,” states “The Case for Capitation,” a Harvard Business Review article.

Under this new business model, physicians have a strong incentive to reduce or eliminate visits to the ER and hospitalization, so ElliQ’s assistance in early intervention and support of proactive and preventative healthcare is highly valuable. ElliQ’s “new capabilities provide physicians with visibility into the patient’s condition at home while allowing seamless communication… can assist me and my team in early detection and mitigation of health issues, and it increases patients’ involvement in their care through more frequent engagement and communication,” says in a statement Dr. Peter Barker of Family Doctors, a Mass General Brigham-affiliated practice in Swampscott, MA, that is working with Intuition Robotics.

With the new stage in its evolution, ElliQ becomes “a conversational agent for self-reported data on how people are doing based on what the doctor is telling us to look for and, at the same time, a super-simple communication channel between the physician and the patient,” says Skuler. As only 20% of the individual’s health has to do with the administration of healthcare, Skuler says the balance is already taken care of by ElliQ—encouraging exercise, watching nutrition, keeping mentally active, connecting to the outside world, and promoting a sense of purpose.

A recent article in The Communication of the ACM pointed out that “usability concerns have for too long overshadowed questions about the usefulness and acceptability of digital technologies for older adults.” Specifically, the authors challenge the long-held assumption that accessibility and aging research “fall under the same umbrella despite the fact that aging is neither an illness nor a disability.”

For Skuler, a “pyramid of value” is represented in Intuition Robotics offering. At the foundation is the physical product, easy to use and operate and doing what it is expected to do. Then there is the layer of “building relationships based on trust and empathy,” with a lot of humor and social interaction and activities for the users. On top are specific areas of value to older adults, and the first one is healthcare. There will be more in the future, anything that could help older adults live better lives, such as direct connections to the local community. ”Healthcare is an interesting experiment and I’m very much looking forward to see what else the future holds for ElliQ,” says Skuler.

Original. Reposted with permission, 7/7/2021.

Digital Therapeutics: A Threat or Opportunity to Pharmaceuticals

Posted in Artificial Heart, Artificial Intelligence - Breakthroughs in Theories and Technologies, Artificial Intelligence - General, Artificial intelligence applications for cardiology, Artificial Intelligence Applications in Health Care, Artificial Intelligence in Health Care - Tools & Innovations, Artificial Intelligence in Medicine - Application for Diagnosis, Artificial Intelligence in Medicine - Applications in Therapeutics, Artificial Pancreas for Type1 Diabetes, Artificial Vascular Structures, Biological Engineering, Digital HealthCare – biotech & internet joint ventures, Disease Biology, Drug Carrier Design, Drug Delivery Platform Technology, Drug Development/Formulation using 3D Printing, Electronic Health Record, Health Economics and Outcomes Research, Health Law & Patient Safety, HealthCare IT, Healthcare Reform, Intelligent Information Systems, Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mobile Healthcare, Organ-on-a-Chip, Personal Health Applications: Tech Innovations serves HealhCare, Population Health Management, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Transformative Technologies in Healthcare, Voices of Patients and Healthcare Providers, Wearable Tech + Digital Health, tagged digital solution, digital therapeutics, Pharmaceuticals, Therapy, treatment on March 18, 2019| Leave a Comment »

Digital Therapeutics: A Threat or Opportunity to Pharmaceuticals

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

3.3.7

3.3.7 Digital Therapeutics: A Threat or Opportunity to Pharmaceuticals, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

Digital Therapeutics (DTx) have been defined by the Digital Therapeutics Alliance (DTA) as “delivering evidence based therapeutic interventions to patients, that are driven by software to prevent, manage or treat a medical disorder or disease”. They might come in the form of a smart phone or computer tablet app, or some form of a cloud-based service connected to a wearable device. DTx tend to fall into three groups. Firstly, developers and mental health researchers have built digital solutions which typically provide a form of software delivered Cognitive-Behaviour Therapies (CBT) that help patients change behaviours and develop coping strategies around their condition. Secondly there are the group of Digital Therapeutics which target lifestyle issues, such as diet, exercise and stress, that are associated with chronic conditions, and work by offering personalized support for goal setting and target achievement. Lastly, DTx can be designed to work in combination with existing medication or treatments, helping patients manage their therapies and focus on ensuring the therapy delivers the best outcomes possible.

Pharmaceutical companies are clearly trying to understand what DTx will mean for them. They want to analyze whether it will be a threat or opportunity to their business. For a long time, they have been providing additional support services to patients who take relatively expensive drugs for chronic conditions. A nurse-led service might provide visits and telephone support to diabetics for example who self-inject insulin therapies. But DTx will help broaden the scope of support services because they can be delivered cost-effectively, and importantly have the ability to capture real-world evidence on patient outcomes. They will no-longer be reserved for the most expensive drugs or therapies but could apply to a whole range of common treatments to boost their efficacy. Faced with the arrival of Digital Therapeutics either replacing drugs, or playing an important role alongside therapies, pharmaceutical firms have three options. They can either ignore DTx and focus on developing drug therapies as they have done; they can partner with a growing number of DTx companies to develop software and services complimenting their drugs; or they can start to build their own Digital Therapeutics to work with their products.

Digital Therapeutics will have knock-on effects in health industries, which may be as great as the introduction of therapeutic apps and services themselves. Together with connected health monitoring devices, DTx will offer a near constant stream of data about an individuals’ behavior, real world context around factors affecting their treatment in their everyday lives and emotional and physiological data such as blood pressure and blood sugar levels. Analysis of the resulting data will help create support services tailored to each patient. But who stores and analyses this data is an important question. Strong data governance will be paramount to maintaining trust, and the highly regulated pharmaceutical industry may not be best-placed to handle individual patient data. Meanwhile, the health sector (payers and healthcare providers) is becoming more focused on patient outcomes, and payment for value not volume. The future will say whether pharmaceutical firms enhance the effectiveness of drugs with DTx, or in some cases replace drugs with DTx.

Digital Therapeutics have the potential to change what the pharmaceutical industry sells: rather than a drug it will sell a package of drugs and digital services. But they will also alter who the industry sells to. Pharmaceutical firms have traditionally marketed drugs to doctors, pharmacists and other health professionals, based on the efficacy of a specific product. Soon it could be paid on the outcome of a bundle of digital therapies, medicines and services with a closer connection to both providers and patients. Apart from a notable few, most pharmaceutical firms have taken a cautious approach towards Digital Therapeutics. Now, it is to be observed that how the pharmaceutical companies use DTx to their benefit as well as for the benefit of the general population.

References:

https://eloqua.eyeforpharma.com/LP=23674?utm_campaign=EFP%2007MAR19%20EFP%20Database&utm_medium=email&utm_source=Eloqua&elqTrackId=73e21ae550de49ccabbf65fce72faea0&elq=818d76a54d894491b031fa8d1cc8d05c&elqaid=43259&elqat=1&elqCampaignId=24564

https://www.s3connectedhealth.com/resources/white-papers/digital-therapeutics-pharmas-threat-or-opportunity/

http://www.pharmatimes.com/web_exclusives/digital_therapeutics_will_transform_pharma_and_healthcare_industries_in_2019._heres_how._1273671

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/exploring-the-potential-of-digital-therapeutics

https://player.fm/series/digital-health-today-2404448/s9-081-scaling-digital-therapeutics-the-opportunities-and-challenges