A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management. Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management. The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.
“I think having options is the key," Suchitra Chandrasekaran, M.D., told Fierce Healthcare. Chandrasekaran runs a postpartum cardio metabolic clinic at Emory University School of Medicine where she aims to utilize a handful of care modalities to reflect idiosyncratic pregnancy paths.
One in three counties in the U.S. is considered a maternal healthcare desert.
Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to "multimodal" technology strategies to predict health emergencies before they happen.
Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
Lucienne Ide, M.D., is the CEO of digital health company Rimidi. She sees the country teetering on an inflection point.
“We're at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we're proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
“But the alternate narrative is really, really bad and it's going to get worse. It's not like, 'Here we are today, and we could do better.' No, here we are today and it's going to get worse, but we can actually do better,” she said
Since 2019, the country has gone from 20.1 maternal deaths per 100,000 live births to 32.9, a 61% increase. According to the Mayo Clinic, high blood pressure, obesity, diabetes, infection and heart or blood disorders increase the risk of pregnancy.
Multimodal methods of care and the power of prediction
Rimidi helps patients collect their own stats with tools like blood pressure cuffs to predict preeclampsia and glucometers to predict gestational diabetes. Patients can then text results, which are incorporated into electronic health record (EHR) systems, and then be connected with a nurse.
Ide believes that RPM pairs well with expanding holistic care models. Reactive fee-for-service models may not kick into high gear until a patient recovering from pregnancy shows up at an emergency room experiencing a stroke. She says RPM allows for a “preventative mindset [and] a proactive management mindset.”
While hospitals often aim to reduce costs by decreasing readmissions, Ide suggests a slight shift in mentality. Instead of avoiding readmission altogether, providers can readmit a high-risk person before something worse happens.
“A woman comes to the ER having a seizure postpartum due to eclampsia,” Ide said. “That's not how we want them coming back to the hospital. We want them coming back to the hospital because they have elevated blood pressure before it causes serious sequelae, like a seizure.”
Rimidi partnered with Boston Medical Center to use its software platform to manage chronic conditions. The medical center’s department of obstetrics and gynecology integrated the platform into its EHR system to monitor high-risk pregnancies. The collaboration began in the early months of the pandemic when creative solutions were necessary.
Kaiser Permanente Northern California took a similar approach by implementing telehealth visits for pregnant people. Senior Research Scientist Assiamira Ferrara, Ph.D., studied the resulting data to assess the virtual visits' effects on care.
She found that during the pandemic, telemedicine visits increased from comprising 11% of pregnancy appointments to 21%, according to the study published in JAMA Network open. While overall appointments did not increase, health outcomes did not take a hit. A multimodal approach led to similar rates of preeclampsia, eclampsia, severe maternal morbidity, C-section delivery or preterm birth compared to an in-office-only approach.
“We saw that you can use the telehealth without harming the patient,” Ferrara told Fierce Healthcare. “This may reduce some barriers for people who have less time to go to the doctor's office because they don’t have a flexible job, or do not have transportation, or they don't have childcare for the kids. It’s also had very good uptake in Northern California’s two maternal health desert regions.”
Despite California having a robust network of maternal care, Ferrara sees the results holding across the country. She calls the use of multimodality forms of healthcare a COVID-era “natural experiment" that fortunately panned out.
Meeting patients where they're at in the postpartum danger window
As the country was forced to move to telehealth, the maternal mortality crisis is inviting in other creative models of care. Ferrara hopes to look at data for a current Kaiser Permanente pilot study implementing self-monitoring of blood pressure and fetal heartbeats during pregnancy.
While roughly 22% of maternal deaths occur during pregnancy and a quarter take place on the day of delivery or within a week after, over half take place between seven days to a year after pregnancy, according to the Centers for Disease Control and Prevention.
In response to the disproportionate number of deaths in the year following pregnancy, extending postnatal Medicaid coverage from six weeks to a full year has been proposed in Congress.
Suchitra Chandrasekaran, M.D., is an assistant professor in the Department of Gynecology and Obstetrics at Emory University School of Medicine. She moved to Georgia with the goal of addressing maternal deserts and now runs a postpartum cardio metabolic clinic where she meets with patients 12 weeks after giving birth.
“We don't have standardized care,” Chandrasekaran told Fierce Healthcare. “I think we're at the initial stage, and we're here to figure out what's best. I offer telemedicine, even in the local Atlanta region. Remote care is great in an urban center where getting a baby and a mom out of the house is not an easy feat for people.”
Chandrasekaran hopes to expand her practice to a regional clinic. Pregnant people can go to a partnered department of public health clinic, get their blood pressure taken, have blood glucose checked and then jump on a telehealth call with her Atlanta-based clinic. Other patients can receive remote patient monitoring devices and report back to her centralized office. This way, Chandrasekaran hopes to identify patients most at risk before a health emergency occurs.
Just as broad and varied are the experiences of pregnancy and birth, Chandrasekaran says solutions should reflect that multiplicity of experiences. Some programs might use text messages connected to blood pressure monitors, some ask patients to call in their stats, others might allow patients to come in person if they so choose.
“It's hard to really standardize immediate postpartum, because what if you have a baby in the NICU that changes your ability to do things? What if you live three hours away from your delivering hospitals?” Chandrasekaran said. “I think having options is the key.”
TrueCare is a community health center in the North San Diego and Riverside Counties area focused on providing quality healthcare to underserved communities.
Because it is a community health center, it provides care to underserved communities, which often have a higher prevalence of uncontrolled hypertension, or high blood pressure. That increases the risk for heart disease and stroke, two of the leading causes of death in the country.
Given that 79% of TrueCare patients are of a racial or ethnic minority and 94% live below the 200% federal poverty line, the provider organization needed to improve hypertension control for patients. It decided to do so via remote patient monitoring technology.
value RPM has on improving patient engagement and outcomes
, we wanted to find the right RPM technology to help us better manage our growing hypertension patient population," said Dr. Denise Gomez, a primary care physician and director of adult medicine at TrueCare.
The organization went with vendor Rimidi, which combines clinical decision support, remote patient monitoring and patient-reported outcomes in a unified, FHIR-based platform.
"While we tried other RPM technologies before, the tools were difficult to use and we didn’t see the value we needed for our patients," Gomez recalled. "Thus, we were attracted to Rimidi’s platform for three main reasons."
These reasons, she explained, included:
The platform enables patients who do not have constant, reliable access to WiFi or smartphones to use the technology. This is because the platform integrates with cellular-enabled blood pressure cuffs, which transmit data from the device directly to the platform for their doctor to be able to see their home blood pressure data, without needing WiFi, smartphones, hubs or apps.
The vendor has been doing business for 11 years – more than the five-year minimum TrueCare desired. It has the experience to know what works and what doesn't work.
The vendor integrates with TrueCare's Epic OCHIN EHR.
There are many vendors of connected health and remote patient monitoring technology and services on the health IT market today.
Healthcare IT News
published a special report highlighting many of these vendors with detailed descriptions of their products.
to read the special report.
MEETING THE CHALLENGE
When TrueCare first began its current RPM program, it worked directly with the Rimidi team and designed the program workflow within the platform, which included setting customized alert thresholds, automated text messaging in the patient’s preferred language and clinical decision support cards to identify when a patient is consistently not taking their readings.
"To get patients into the RPM program, they had to first be referred by one of our primary care providers," Gomez said. "The qualification was having consistent uncontrolled blood pressure, which was defined by TrueCare as greater than 140/90 mmHg on more than two occasions.
"Once referred, patients then would meet with health coaches who would provide them with instructions on how to use their cellular-enabled blood pressure device, as well as education about their current BP medications, diet and exercise," she continued. "During this meeting, the health coaches would also add the patient to the platform and connect their cellular-enabled device to monitor the patient’s daily readings in near-real time."
Patients then are monitored for readings greater than 140/90. Patients who have met their blood pressure goal are able to return their monitor, and the devices are cycled to newly identified patients who need the care. If the blood pressure goal is not met, the pharmacist or provider is alerted and medications are adjusted.
"We began the program in January 2023 and have continued to ramp up implementation and grow the number of patients each month," Gomez said. "As of April 2023, we have had 70 patients enrolled into the program, with an average of 10 additional patients per month. Impressively, 34 patients have graduated from the program so far, meaning their blood pressure has been controlled.
"Additionally, we see around 30 readings per patient per month on average, meaning we have a high level of compliance among our patients," she added. "Our providers also have been able to reduce medications for patients as a result of their improved hypertension control."
Another interesting note: The program has helped TrueCare identify
white coat hypertension
in patients, which is when an individual has higher blood pressure readings at the doctor's office than in other settings, such as at home.
ADVICE FOR OTHERS
"It’s important to note that federally qualified health centers and community health centers can’t be reimbursed for RPM," Gomez said. "Therefore, they must rely on grant opportunities and other models of sustainability.
"In our instance, we were able to add Rimidi’s RPM technology with support from a Health Resources and Service Administration hypertension grant," she noted. "While we will continue to look for grant opportunities to expand the program, we also determined in order to sustain the program, we need to add one extra in-person visit for every 13 patients enrolled in Rimidi based on our Preferred Payment System reimbursement amount."
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California’s Desert Oasis Healthcare (DOHC) implements Rimidi’s Respiratory Module for respiratory patient monitoring, based on data collected by Teva’s Digihaler® System
Digihaler is the first and only smart inhaler system that can provide objective data to help patients and their doctors better support asthma management
Teva and Rimidi look to expand respiratory monitoring program to additional health systems with the aim of assessing potential cost savings, hospitalization rates and the quality of asthma management
PARSIPPANY, N.J.--(BUSINESS WIRE)--
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that a respiratory patient monitoring program using data from Teva’s Digihaler System has been implemented within California’s Desert Oasis Healthcare (DOHC) system. The program was designed in collaboration with Rimidi, a leading clinical management platform designed to optimize clinical workflows, enhance patient experiences and achieve quality objectives. Teva’s Digihaler is the first and only smart inhaler system that can provide objective data to help patients and their doctors better support asthma management
The implementation of this respiratory monitoring program in a large health system is a vital step in helping to ensure patients are getting the resources they need to develop informed treatment plans with their doctors. Teva and Rimidi continue to look for ways to expand this respiratory monitoring program by partnering with additional health systems in an effort to reduce high costs, lower hospitalizations and improve asthma management.
“Teva aims to be a leader in fusing technology and healthcare in order to help patients and their doctors more easily manage their treatment plans. Through collaborations with partners like Rimidi, we hope to improve the patient continuum of care, leading to a more cost-effective healthcare system,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “More than 34 million Americans live with a chronic lung disease, and approximately 25 million people in the U.S. currently have asthma.
We’re energized by the potential of collaborations like this to drive meaningful differences in how asthma is managed and treated, with the collective vision of one day predicting asthma attacks before they occur.”
Through this collaboration, DOHC has identified patients with respiratory conditions indicated for treatment with one or more of the products in Teva’s Digihaler family of inhalers, and who are appropriate candidates for enrollment via the Rimidi platform. Data from Teva’s Digihaler System will be available through Rimidi’s Respiratory Module, which is designed to give providers a more complete view of the patient to help guide treatment decisions for those with respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or asthma.
“The ability to have a streamlined, comprehensive view of a patient’s health condition allows for more efficient and personalized management,” said Lucienne Ide, MD, PhD, Founder and CEO of Rimidi. “Rimidi’s Respiratory Module incorporates clinical decision support tools to help clinicians understand potential reasons behind a patient’s uncontrolled asthma, such as not taking their medication or not taking it properly. These factors are fundamental to achieving good asthma control.”
Integrating data from the smart inhalers into the clinician’s electronic health records through the Respiratory Module can help support the management of COPD and asthma. Longer term, outcomes from DOHC’s initial patient cohort will provide valuable insights to inform the use of data from Teva’s Digihaler System and the module in U.S. health systems. The platform can be used to monitor and manage large populations by a network of health systems, capturing objective and actionable data for asthma patients. The goal is to assess how this approach can help address high costs, lower hospitalizations and improve asthma management.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at
About Teva Digital Health
Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform, Digihaler
– developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S. Learn more at
Created by doctors, Rimidi’s leading clinical management platform empowers healthcare organizations to optimize clinical workflows, enhance patient experiences and achieve quality objectives. By bringing together clinical decision support, remote patient monitoring and patient reported outcomes in a unified, composable, FHIR-based platform, Rimidi supports a broad range of clinical use cases and institutional priorities across large and small healthcare organizations. For more information, visit
and follow us on Twitter and LinkedIn.
About Desert Oasis Healthcare
Formed in 1981 as one of the first medical groups in the desert communities of southern California, Desert Oasis Healthcare (DOHC) continues to advance with changes in the healthcare market. DOHC provides primary and immediate care, home health, palliative care, and other services to more than 60,000 members/patients living in the greater Coachella Valley and the Morongo Basin of Riverside and San Bernardino counties. The multidisciplinary and comprehensive care programs of DOHC are committed to educating individuals on preventative health care in their daily lives, reflected in the DOHC motto, "Your Health. Your Life. Our Passion." For more information, visit
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our Digihaler products family; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO
, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
The American Lunch Association. Our Impact (2023).
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Ran Meir (267) 468-4475
Sanjeev Sharma (973) 524-1908
Kelley Dougherty (973) 658-0237
Yonatan Beker (973) 264-7378
Source: Teva Pharmaceutical Industries Limited