Research Is Customizing Artificial Pancreas for Pregnancy

From left: Carol J. Levy, MD; Camilla Levister, NP; Co-Investigator Grenye O’Malley, MD, Assistant Professor of Medicine (Endocrinology, Diabetes and Bone Disease); and Clinical Research Coordinator Selassie Ogyaadu, MD, MPH.

An artificial pancreas system tailored to the specific, and daunting, challenges faced by pregnant women with type 1 diabetes is the goal of a study to be conducted by a consortium of four leading institutions, including the Icahn School of Medicine at Mount Sinai. The project, funded by the National Institutes of Health, is the first of its kind in the United States.

“Pregnant women with type 1 diabetes typically test their blood sugars seven to eight times per day, and many wear glucose sensors, but they still struggle tremendously to keep their blood sugar levels in target ranges,” says Carol J. Levy, MD, Clinical Director of the Mount Sinai Diabetes Center, and the project’s principal investigator at the Icahn School of Medicine.

If blood sugar levels are too low for a prolonged period of time, a pregnant woman can feel poorly, or pass out, and risks seizures. If levels rise too high, there are risks to her unborn child, including malformations, delayed lung maturity, placental malfunction, or fetal death. “The use of customized technology provides an important opportunity to improve patient and fetal outcomes,” says Dr. Levy, Associate Professor of Medicine (Endocrinology, Diabetes and Bone Disease), Icahn School of Medicine at Mount Sinai. “We are excited to be part of the team evaluating this important area of research designed to improve care and reduce patient burden.”

The clinical trials will be conducted by specialists at three sites: Mount Sinai; the Mayo Clinic in Rochester, Minnesota; and the Sansum Diabetes Research Institute in Santa Barbara, California.

The overall principal investigator is Eyal Dassau, PhD, an expert on algorithm design and Director of the Biomedical Systems Engineering Research Group at Harvard University’s John A. Paulson School of Engineering and Applied Sciences.

Each patient participating in the artificial pancreas portion of the study will wear a Dexcom G6 continuous glucose monitoring device and an insulin pump. Both devices are linked with a software algorithm on a smartphone, which identifies a personalized blood-glucose range and prompts doses of insulin with reduced input from the patient. This is also known as a closed loop system because it uses a customized algorithm to close the decision-making loop between the glucose reading and the delivery of insulin, with the goal of improving blood sugar control.

In the artificial pancreas, or closed loop system, a controller—consisting of a software algorithm on a smartphone—receives readings from a continuous glucose sensor and prompts doses from an insulin pump, with reduced input from the patient.

The only artificial pancreas approved by the U.S. Food and Drug Administration is the Medtronic 670G. But it is designed for blood glucose targets between 120 milligrams/deciliter (mg/dL) and 180 mg/dL, while pregnant women with type 1 diabetes aim for a narrower range—under 90 mg/dL while fasting and 130 to 140 mg/dL one hour after meals.

“This is not easy to do, even for the most meticulous patients,” says Dr. Levy. Another challenge is that hormonal shifts in each trimester change the level of resistance to insulin, making the proper dose “a moving target.”

The first clinical trial in the grant—Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P)—is now enrolling 50 pregnant women with type 1 diabetes and will follow their glycemic outcomes into the postpartum period, providing guidance in refining the algorithm. The trial is named for the late Lois Jovanovic, MD, who was a former director of the Sansum Institute and a role model for many in the study of diabetes, including Dr. Levy. The overall project is intended to progress from a sequence of in-clinic studies to a safe and effective at-home clinical trial.

“I view this work as critical for patients, and I have a personal perspective as well, since I have had type 1 diabetes for 48 years,” Dr. Levy says. “I managed my diabetes with my health care team through two pregnancies, and every day was a challenge. Caring clinicians are important, and any support that people with type 1 diabetes can have provides a huge difference. Every time I enroll a patient in the LOIS-P study, I feel as if we are one step closer to a real answer for many women.”

For more information about the clinical trials, call 212-241-9089.

Changing the Paradigm for Patients With Treatment-Resistant Depression

Dennis S. Charney, MD

The U.S. Food and Drug Administration on March 5 approved SPRAVATO™ (esketamine) CIII nasal spray for the treatment of treatment-resistant depression. Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean, Icahn School of Medicine at Mount Sinai, is a co-inventor of a method of treatment, which is patented and part of the drug application for SPRAVATO, a product of the Janssen Pharmaceutical Companies of Johnson & Johnson.

“As a researcher, you strive to come up with new treatments for the patient, especially in terms of finding answers to the most debilitating diseases,” says Dr. Charney, who is also President for Academic Affairs, Mount Sinai Health System. “To know that you oversaw the early development of an approach that can make a difference in the lives of countless individuals is extremely rewarding.”

Esketamine represents the first new mechanism of action in decades to treat major depressive disorder. Delivered in the form of a nasal spray, esketamine works differently than the three classes of antidepressants that are currently on the market. The drug works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. In contrast, widely used antidepressants target different neurotransmitters—serotonin, serotonin and norepinephrine, and norepinephrine and dopamine—and can take weeks or even months to work.

An estimated 30 percent of people who are treated for depression do not respond to therapies. Treatment-resistant depression (TRD) is a devastating disease that is associated with greater morbidity, higher health care costs, and various comorbid conditions.

“We commend Dr. Charney and his colleagues for their work in changing the paradigm for patients with treatment-resistant depression,” says Kenneth L. Davis, MD, President and Chief Executive Officer of the Mount Sinai Health System. “Through his commitment to innovation and science, Dr. Charney has inspired countless researchers to leverage new technologies and create discoveries to benefit the lives of patients around the world—while at the same time leading the Icahn School of Medicine to unparalleled growth and high national rankings.”

In his role as Dean of the Icahn School of Medicine, Dr. Charney says that many younger researchers look to him for advice. “I tell them that in science you’ve got to keep trying, to keep pushing,” he says. “There is a lot to be gained by working in a small group that is engaged in the give and take of scientific interaction. Researchers should understand that failure is going to happen, but they can use that failure as a stepping stone to discovery.”

Conflicts of Interest Disclosure: Dr. Charney is named as co-inventor on patents filed by the Icahn School of Medicine at Mount Sinai (ISMMS) relating to the treatment for treatment-resistant depression, suicidal ideation, and other disorders. ISMMS has entered into a licensing agreement with Janssen Pharmaceuticals, Inc., and it has and will receive payments from Janssen under the license agreement related to these patents for the treatment of treatment-resistant depression and suicidal ideation under this agreement. Consistent with the ISMMS Faculty Handbook, Dr. Charney is entitled to a portion of the payments received by the ISMMS. Since SPRAVATO has received regulatory approval for treatment-resistant depression, ISMMS and thus, through the ISMMS, Dr. Charney will be entitled to additional payments, beyond those already received, under the license agreement.

Continuity of Cardiac Care for South Nassau Patients

Patient Bill Regan with, from left: Robin Varghese, MD; Pilar Stevens-Haynes, MD; and Jason
Freeman, MD—members of the coordinated team that treated him on Long Island and in Manhattan.

Even before an official partnership was finalized in December 2018, specialists from the Mount Sinai Health System were collaborating with physicians at South Nassau Communities Hospital to provide advanced and coordinated care to Long Island patients. For 67-year-old Bill Regan, a retired financial services executive from Massapequa, this new relationship proved to be life-saving.

It was in March 2018 that Mr. Regan decided to try a new primary care physician—this time, at South Nassau Primary Care at Bellmore. During his first visit to Carolyne McHyman, DO, Mr. Regan provided the details of his medical history, which included a carotid endarterectomy, a surgical procedure to clear blockages in the carotid artery in the neck, and prescriptions for high blood pressure and high cholesterol. The former long-time smoker told Dr. McHyman that he was “generally in good health,” but when he also mentioned some daytime fatigue and left leg discomfort when he walked long distances, she ordered several diagnostic tests.

They included a chest CT scan, as part of The Mount Sinai Hospital’s Early Detection Lung Cancer Screening program; an ultrasound of the abdominal aorta to check circulation and to rule out an aortic aneurysm, an abnormal bulge in the aorta; a consultation to rule out a sleep disorder; and a recommendation to see his cardiologist, Pilar Stevens-Haynes, MD, for an evaluation.

The CT scan of the lungs, while negative for lung cancer, showed calcification in his aorta. The ultrasound of the abdominal aorta also showed narrowing of the left iliac artery in his pelvis, while a magnetic resonance angiography, which provides detailed images of blood vessels in the body, revealed a 90 percent blockage of that artery. “Honestly, I didn’t worry about my health, but these test results blindsided me,” recalls Mr. Regan.

Meanwhile, Dr. Stevens-Haynes recommended a cardiac catheterization to check for any blockages of his coronary arteries. “Bill didn’t have previous symptoms of chest pain, but coronary artery calcification can be associated with major adverse cardiovascular events, and we needed to get to the bottom of it,” says Dr. Stevens-Haynes.

When Jason Freeman, MD, Director of Interventional Cardiology at South Nassau Communities Hospital, performed the cardiac catheterization on April 24, he discovered that Mr. Regan’s left main and circumflex coronary arteries that supply blood to his heart were significantly blocked and could not be treated with stents, expandable tubes used to open clogged arteries. Now, Mr. Regan would need open-heart surgery—a diagnosis that was made immediately by Robin Varghese, MD, Associate Professor of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai, who was at South Nassau that day.

South Nassau’s Center for Cardiovascular Health has long been known for its outstanding care. It is a recipient of Healthgrades’ 2019 Coronary Intervention Excellence Award and five stars for its performance in coronary interventional procedures, placing it among the top 10 percent in the nation; however, it does not perform cardiac surgery.

“When I met with Dr. Varghese, the heart surgeon, I was very anxious, but I came out feeling this is going to be okay,” Mr. Regan says. “He walked me through what the procedure entailed. He had a diagram of the heart and the arteries, and he was positive, calming, and reassuring. He made me feel like ‘we got this and this is what we do every day.’”

Long Island patient Bill Regan was able to receive postoperative care, including cardiac rehabilitation, close to home in South Nassau.

On April 30, Dr. Varghese and his team at The Mount Sinai Hospital performed the three-hour surgery to restore blood flow to Mr. Regan’s heart. “After surgery, we took Bill to our Cardiac Surgery Intensive Care Unit,” says Dr. Varghese, who is also Director of Cardiovascular Critical Care for the Mount Sinai Health System. “He was sitting up in the chair in no time and looking great. He surprised us all.” Within four days, Mr. Regan was released from the hospital and was back home on the South Shore under the supervision of South Nassau’s Homecare program, attending church two days later in Massapequa.

“My entire experience was coordinated and supported by the most wonderful people from South Nassau and Mount Sinai,” says Mr. Regan. “I feel blessed, thankful, and overwhelmed with gratitude to everyone, and I mean everyone, involved in my treatment and recovery at South Nassau and Mount Sinai.”

After he was released from South Nassau’s Homecare program, vascular surgeon Xenophon Xenophontos, MD, performed a successful angioplasty of the left iliac artery. Mr. Regan also participated in South Nassau’s Cardiac Rehabilitation program at South Nassau’s Sports Medicine and Rehabilitation Therapy (SMART) Center in Oceanside, which he completed three months ago. Mr. Regan says he plans to return to the SMART Center this month for additional exercise programs.

Having access to advanced specialty care at The Mount Sinai Hospital while being able to stay close to home for pre- and postoperative care offers many benefits for patients. “Continuity of care is a key component of quality of care, especially when treating patients with multiple conditions,” says Adhi Sharma, MD, Executive Vice President for Clinical and Professional Affairs and Chief Medical Officer at South Nassau. “The care was not only life-saving for Bill, but a seamless journey and patient experience.”

 

Mount Sinai Innovation Showcase Nurtures Health Care Solutions

A panel of experts in life sciences and business evaluated presentations and offered feedback. From left: Sean Ianchulev, MD, MPH, Nishta Rao, Brent Stackhouse, Sara Barrington, and John Hammitt.

Teams of young innovators recently presented ideas on how to benefit patients to a panel of experts at the Mount Sinai Innovation Showcase. The event, hosted by Mount Sinai Innovation Partners (MSIP) with support from the SinaInnovations Committee and the Institutes for Translational Sciences (ConduITS), was held on Thursday, February 14, in Davis Auditorium.

The innovators, who came from the Icahn School of Medicine at Mount Sinai, SUNY Stony Brook, Cooper Union, and other New York institutions, included the three finalist teams and one wild-card entry from Mount Sinai’s Health Hackathon in October 2018. After sketching out solutions to address rare diseases at the Hackathon, the teams received coaching from MSIP and the eLabNYC mentoring program and learned how to merge product development with business strategy and improve their product based on consumer needs.

A diet-tracking app called Demeter was pitched by young innovators. From left: Alyssa Mango, Ryan Neff, and Leah Osnos.

Their projects included: Eye Can Do, a smartphone-based eye tracking technology for immobile patients; Walk Thru, a portable accessory for patients using a walker to facilitate getting through doors; Demeter, a smartphone application that provides diet tracking, management, and symptom assessment for patients of metabolic disorders; and Dormi, a tracking device to assess and monitor sleep patterns.

A panel of experts in life sciences and business fields offered feedback, including: Jim Heitner, Associate Director of the Mount Sinai i3 Accelerator; Nishta Rao, Director of Princeton Innovation Center BioLabs; John Hammitt, Executive Director of HITLAB Healthcare Innovation Lab; Sara Barrington, Chief Executive Officer of Cynvenio Biosystems Inc.; Sean Ianchulev, MD, MPH, Director of the Ophthalmic Innovation and Technology Program at the New York Eye and Ear Infirmary of Mount Sinai; and Brent Stackhouse, Vice President of Mount Sinai Ambulatory Ventures.

The teams are now pursuing next steps by improving prototypes, initiating clinical studies, and continuing to work with MSIP. The showcase event reinforced Mount Sinai’s mission to provide exceptional patient care and clinical leadership by cultivating innovation through research. Mount Sinai engages MSIP to translate discoveries into products or services that benefit patients.

Front row, from left: Sean Ianchulev, MD, MPH, Director of the Ophthalmic Innovation and Technology Program at the New York Eye and Ear Infirmary of Mount Sinai; Sara Barrington, Chief Executive Officer of Cynvenio Biosystems Inc.; and John Hammitt, Executive Director of HITLAB Healthcare Innovation Lab. Back row, from left: Jim Heitner, Associate Director of the Mount Sinai i3 Accelerator; Nishta Rao, Director of Princeton Innovation Center BioLabs; Cynthia Cleto, Associate Director, Marketing and Outreach at MSIP; and Brent Stackhouse, Vice President of Mount Sinai Ambulatory Ventures.

Road to Resilience Episode Nine: The Mystery Virus

Douglas Dieterich, MD, and Leigh Blake

In 1977, Doug Dieterich contracted a mysterious virus that attacked his liver and left him unable to work. Four decades later, Dr. Dieterich, Director of the Institute for Liver Medicine at The Mount Sinai Hospital, reflects on his journey from patient to caregiver with the help of an unlikely ally—AIDS activist and “Cockney Rebel” Leigh Blake—and explains why Hepatitis C isn’t the terrifying diagnosis it once was.

Dr. Dieterich and Leigh explain how they turned their diagnosis into positive action. “I’ve always felt that when pain comes, you have to use it,” Leigh says, “That’s what it’s designed for.” Leigh’s Hepatitis C diagnosis inspired her to expand her humanitarian work, thereby saving thousands of lives affected by HIV/AIDS, while Dr. Dieterich’s diagnosis inspired him to become a renowned liver specialist.

Road to Resilience brings you stories and insights to help you thrive in a challenging world. From fighting burnout and trauma, to building resilient families and communities, we explore what’s possible when science meets the human spirit. Powered by the best experts in the world. The series is based on the well-received book Resilience: The Science of Mastering Life’s Greatest Challenges, co-authored by Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, and Steven Southwick, MD, Professor of Psychiatry at Yale University.

Road to Resilience is available on Apple Podcasts, Spotify, Stitcher, and Google Play (link works best in Chrome). New episodes of the series are released on the last Wednesday of each month. You can find more information on the Icahn School of Medicine website or on the Road to Resilience website.

 

New Program Achieves Early Benchmarks For Improving Patient Care Post-Discharge

The Transitions of Care Center team includes, from left: Amanda Anderson, MSN, MPA, RN; Claudia Colgan; and Eunice Reynoso, BSN, RN, Clinical Nurse Manager.

When a patient is admitted to a hospital within the Mount Sinai Health System, planning for discharge begins almost immediately to ensure a smooth transition to the next level of care, whether it is at home or at a skilled nursing facility. Studies show that effective discharges lead to improved patient health, reduced readmissions, and decreased health care costs.

Toward that end, the Mount Sinai Health System has established the Transitions of Care Center (TOCC), a centralized telephone-based discharge program staffed by Mount Sinai registered nurses who are specially trained in hospital discharge protocols and are led by a clinical nurse manager.

The TOCC has been tasked with improving patient satisfaction, ensuring patients have access to post-hospital care and are following discharge instructions, and preventing avoidable readmissions. Staff work from a dedicated office on East 16th Street near Union Square in Manhattan, where 11 registered nurses call Mount Sinai patients 24 to 72 hours after they leave the hospital—reviewing and addressing each patient’s unique discharge plan of care.

The Center initially was launched in December 2016 as a pilot program aimed exclusively at patients deemed at high risk for rehospitalization. The program quickly expanded and is now servicing patients regardless of readmission risk or diagnosis who are discharged home from The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West, and Mount Sinai St. Luke’s. In March, the TOCC will add discharged patients from Mount Sinai Brooklyn, with a goal to expand to Mount Sinai Beth Israel in the coming months.

Since the program’s start, nurses have made more than 40,000 phone calls, spoken to nearly 19,000 patients, and provided close to 11,000 interventions to assist patients with post-discharge care needs. “The results have been positive,” says Claudia Colgan, Vice President, Care Coordination, Mount Sinai Health System, and Vice President, Operations, The Mount Sinai Hospital. “In the 12 months leading up to August 2018, patients who were contacted by the TOCC had a 16 percent lower-than-expected readmission rate.”

The Transitions of Care Center nursing staff includes Verisa Robinson BSN, RN, center, and from left: Alla Aminova, BSN, RN; Maki Lahori, BSN, RN; Kristina Davanzo, BSN, RN; Amanda Mendez- Paranavitana, BSN, RN; Connie Fong, BSN, RN; and April Schott-Auerbach MSN, RN, CNL.

While speaking to patients, nurses assess their health status and determine if they are adhering to their discharge care plan. They ensure that patients have filled their prescriptions and are taking their medications properly, that they have the medical equipment they need, and that they are able to attend follow-up appointments. As needed, they perform nursing triage for active symptoms, referring patients  to in- and out-patient providers. They work closely with interdisciplinary care management teams at the hospital where the patient was treated and collaborate with ambulatory teams, home health agencies, and community-based service organizations.

According to TOCC data from January 2017 through November 2018, nurses had 6,290 patient interventions that involved providing educational resources and reinforcing overall discharge instructions, and 1,013 interventions that resolved medication needs. They also helped escalate the management of active symptoms for 825 patients.

“No matter how well the discharge team explains next steps of care, patients often do not fully understand or remember what to do,” says Ms. Colgan. “This is pervasive across the entire patient population, regardless of education or language proficiency or socioeconomic status. At Mount Sinai, we understand that they may be overwhelmed with new directives.”

Mount Sinai is one of the few facilities in the country with a dedicated team of on-staff nurses whose full-time job is to call patients. “Our success lies with our registered nursing team,” says Amanda Anderson, MSN, MPA, RN, Associate Director of Care Transitions for the Mount Sinai Health System. “The TOCC nurses are highly trained by Health System service-line leaders. They understand the Mount Sinai culture of putting patients first, and they collaborate with other hospital staff on the patient’s behalf when necessary.”

“It’s great when we are able to triage and provide a service to someone who really needs it,” says TOCC Senior Nurse April Schott-Auerbach, MSN, RN, CNL. “One of my patients was experiencing increasing shortness of breath and it was clear he needed assistance but was unable to get to an urgent care facility or go back to the emergency room. I was able to triage and collaborate with the Health System Community Paramedicine team, which provided the patient with the more immediate assessment he needed.”

According to Ms. Schott-Auerbach, patients are happy knowing that someone is following up with them. One of her patients told her, “I never had such amazing service from other hospitals. It really makes me feel like Mount Sinai cares about me.”

A team picture: The Transitions of Care team.