Joshua Miller, MD MPH and medical director of diabetes care for Stony Brook Medicine, discusses continuous glucose monitoring (CGM) technology, which the FDA has authorized for use in hospitals amid the COVID-19 pandemic.
Drug Topics®: Hi, this is Gabrielle Ientile with Drug Topics®. Today I'm going to be interviewing Dr. Joshua Miller, MD, MPH, and medical director of diabetes care for Stony Brook Medicine.
Our topic is continuous glucose monitoring (CGM) technology, which the FDA has authorized for use in hospitals amid the COVID-19 pandemic. Before we get started, here's the latest news from Drug Topics®.
An ongoing clinical trial led by Oxford University investigating a potential vaccine against COVID-19 reported encouraging early results according to the investigators. The phase 1 study found that a single dose of the vaccine prompted effective immune and T-cell responses. The vaccine was co-created by the University of Oxford through a replication deficient chimpanzee viral vector based on a weakened version of adenovirus, a common cold virus, which causes infections in chimpanzees. Adenovirus also has genetic material of the SARS-CoV-2 virus spike protein.
That's the latest news from Drug Topics®. Now here's my interview with Dr. Miller.
Drug Topics®: So before we get into our topic, continuous glucose monitoring, can you provide a little bit of your professional background in diabetes management?
Miller: Sure. I am the medical director of diabetes care for Stony Brook Medicine on Long Island. We are the largest academic medical center in Suffolk County. We provide care for over 7000 patients with diabetes a year in the hospital, and 10s of thousands of patients in the community with diabetes and other chronic diseases. I have been a diabetologist now for about eight years. But I've been a diabetologist in another sense for far longer. I've been living with type 1 diabetes for the last 21 years and have a particular interest in devices that help my patients and help me live a better life with diabetes.
Drug Topics®: Great, so can you describe what is currently known about COVID-19 patients with diabetes and their likelihood for severe symptoms, ventilation use and death rates?
Miller: We're learning quite a bit about the impact of COVID-19 on people living with diabetes. I think the area of greatest interest right now is exploring whether having diabetes itself puts you at greater risk of getting the virus. We do believe that's the case.
But if you have well controlled diabetes versus diabetes that is uncontrolled, where the blood sugars are particularly high, does that put you at an increased risk of having poor outcomes from the virus.
We're also now exploring some of the nuances associated with type of diabetes and risk of COVID-19 - do people with type one diabetes have a different risk for COVID-19 than people with type 2? I will tell you what our institution and we're in the process of publishing this data, we have shown that people with diabetes admitted to the hospital of COVID-19 have a significantly higher mortality rate, significant morbidity as well, in terms of risk of going on the ventilator, time to get weaned off of the ventilator and whatnot. So diabetes is most certainly a comorbidity and a risk factor for COVID-19. I think, as more data is shared, and more institutions and systems collaborate, like we are at Stony Brook, I think we'll learn a lot more that we'll be able to share with the public about their specific risks in both getting the virus and in surviving the virus long term.
Drug Topics®: So then, can you describe the changes that CGM technology has brought to your hospital? What was the process of treating COVID-19 patients prior to CGM use in your hospital and then following as well.
Miller: We've seen continuous glucose monitoring to be transformational in helping us to care for patients with COVID-19 during the pandemic.
Early on in the pandemic, as you know, New York was hit hard with the early surge and Stony Brook Medicine was one of the institutions that had to rise to the occasion in helping the community deal with the virus. And part of our plan in helping our staff to care for patients with the virus was to lower, to the extent that we can, the impact the virus might have on staff and their safety, while maintaining the highest of standards of care in providing care for patients.
Back in the spring, the FDA gave guidance to industry about CGM, in so far as they allowed industry to fulfill orders for continuous glucose monitoring systems to be used by hospitals amidst the pandemic. We were delighted. We have a diabetes program at Stony Brook with a multidisciplinary team of staff that are focused day in and day out on caring for people with diabetes. We have the architecture, the infrastructure, to implement CGM successfully during the pandemic.
I will say that our use of CGM at Stony Brook during the pandemic was somewhat novel in that many institutions used CGM in different populations of patients than we did. We deployed continuous glucose monitors in the sickest of patients. We used CGM, as we continue to use CGM, in admitted patients with diabetes and COVID-19, who are critically ill in our intensive care units.
The reason for that approach is we felt that those sickest patients were those individuals that required the most intense monitoring of their diabetes and the blood sugar control, as well as the most aggressive approach to insulin management and medications to control diabetes. Having that added insight by using CGM in the ICU, profoundly impacted care for those patients.
We also use CGM in the ICU. Because every time a nurse has to go into the room of a patient with COVID-19, he or she has to don full PPE. And that utilizes a lot of equipment over time that amidst the height of the pandemic and the surge in New York in the tri state area, we were as focused as anyone on conserving PPE to keep our staff safe. CGM for our patients in the ICU, allowed our nurses in our team to safely monitor patients just outside of the room so that they did not have to don full PPE every time they went into the room to check a blood sugar for the patient.
Our preliminary data has shown a reduction in PPE utilization for our staff and upwards of 50%. We were able to reserve and conserve PPE all the while maintaining our high standards of care for patients with diabetes, while having increased access to that glucose tracing on the CGM that we did not have before.
I would say overwhelmingly, it's been transformational for patient care, it's been transfer transformational for our clinical team, and it's been transformational for our nursing staff who are helping us to monitor and care for our patients.
Drug Topics®: Dr. Miller, thank you so much for joining me today.
Miller: Thanks for the wonderful questions. I wish you luck and stay safe.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.