NOVEMBER 2021
By Derek Bagley
Thanks to insulin’s discovery a century ago, diabetes is no longer the death sentence it once was. However, providing care can often be complicated for both in- and outpatient treatment regimens. Potential new models of diabetes care could help ease the burden of both the patients and the providers, whether treatment takes place at home, in the office, or in a hospital setting
When Jim Malone, MD, was treating patients with diabetes, he would have 15-minute appointments and he’d have to spend 10 of those minutes looking at the patient’s handwritten logbook trying to decipher any patterns that might point to a need for adjustments in the treatment regimen. That would only leave five minutes for a physical exam – feet, eyes, etc. – and then finally ask the patients how they’re doing. “I didn’t have time to cover everything,” he says.
It has been 100 years now since insulin turned diabetes from a death sentence to a manageable condition, when Sir Frederick Banting wrote down his idea that would change the world. A little under 70 years after his discovery, the Flame of Hope was completed near Banting’s house — now a museum in London, Ontario, Canada — and kindled by Queen Elizabeth. The gas-powered eternal flame is dedicated to all who have been affected by diabetes and will be extinguished the day a cure is discovered.
Still, diabetes care can be complicated, from expensive medications and devices to a lack of understanding what’s expected for optimal care, whether that’s on the provider or the patient. Pumps and artificial pancreas systems are great technology but can often be difficult to operate. So, until a cure is found, diabetologists and endocrinologists are innovating and shifting to new models of diabetes care, models that begin with making sure the clinicians have the time to cover everything and helping to make sure the patients understand how to best care for themselves, so that maybe diabetes fades into the background of these patients’ lives. Until managing this disease becomes second nature, which can seem like a cure to many patients with diabetes.
Here, we’ll take a look at two new models of diabetes care – one industry-driven, one policy-driven – that should benefit patients and their physicians in both outpatient and inpatient settings.
Easing the Patient’s Burden
Malone, after spending 12 years in practice and then more than 20 years as a clinical researcher at Eli Lilly, is now chief medical officer at Bigfoot Biomedical in Milpitas, Calif. a medtech company dedicated to easing the burden of living with insulin-requiring diabetes. Malone and his team have developed the Bigfoot Unity™ Diabetes Management Program, featuring innovative technologies and proactive, remote-care solutions designed to support clinicians and their population of patients with type 1 and type 2 diabetes on multiple daily injections (MDI) of insulin.
Bigfoot Biomedical co-founder and CEO Jeffrey Brewer tells Endocrine News that he was drawn to insulin research and how to use the drug safely when his son was diagnosed with type 1 diabetes in 2002. Prior to that, Brewer was a dot-com entrepreneur, but he says in the 19 years since his son was diagnosed, he has spent the majority of his time thinking about and working on how to live safely with insulin. (His son ended up in the intensive care unit twice, each time after mistakes with doses.)
Brewer got involved with JDRF where he helped establish the Artificial Pancreas Project, an effort to significantly accelerate both academic and industry research leading to the development of automated insulin delivery systems. He later served as CEO of JDRF. “The challenge with insulin is it is a very unique drug in that you have to determine the dose, and that requires a big obligation on the part of the person with diabetes and frankly it’s just too hard,” he says.
Here’s how Bigfoot Unity works: When a clinic contracts with Bigfoot, they can begin prescribing the FDA-cleared Bigfoot Unity™ System, which features connected smart caps for the patient’s long- and rapid-acting disposable insulin pens that integrate with Abbott’s FreeStyle® Libre 2 CGM sensor. The system is designed to help the patient follow their prescribed insulin therapy regimen. During use, there’s no data entry required of the patient. The patients simply scan the sensor with the pen cap, press a button and get on-demand insulin dose recommendations based upon the patient’s current CGM data and their clinician’s instructions.
For the clinician, the Bigfoot Unity Program provides the secure, cloud-based tools to access their Bigfoot Unity patient data in order to remotely review therapy adherence. Data from their Bigfoot Unity patients are passively captured and automatically uploaded to the Bigfoot Clinic Hub™. Patient reports with integrated glucose and insulin data enable clinics to track their Bigfoot Unity patients at the population level, identify key patterns and triage, for example by patients frequently experiencing low or high glucose values. “What we’re doing is working to transform a primarily reactive, episodic therapy for MDI patients into a continuous, proactive approach,” said Brewer. “Bigfoot Unity makes it possible for clinicians to make informed, timely therapy adjustment decisions between office visits with a goal of helping them minimize potential issues.”
Bigfoot’s Certified Diabetes Care and Education Specialists provide patient onboarding and training for the Bigfoot Unity technologies, including those patients new to CGM or to MDI therapy itself. One of the early patients to be prescribed the program was on a fixed-dose mealtime insulin regimen and one dose of long-acting insulin. “She got trained on the Bigfoot Unity system, was taught about correction doses which are displayedp on the pen cap,” Malone says. “She doesn’t need to think about her dose. Once she scans her sensor, the CGM glucose is displayed on the pen cap, and then the correction dose pops up right on the pen cap, along with her mealtime dose.”
Malone goes on to say that within two weeks, this patient’s average CGM reading dropped about 100 mg/dl. “Obviously not all patients are like that, but that really showed us that the system is doing what we designed it to do, help people manage their diabetes.”
Supply and Demand: Endocrine Hospitalists
Of course, patients with diabetes still can find themselves in the hospital from time to time, unfortunately. When that happens, the risk of hyperglycemia and hypoglycemia should come into sharper focus but managing patients’ blood sugars and reporting on glycemic metrics has been a blind spot for many hospitals. For instance, according to the recent CMS report, “Although there are many occurrences of hypoglycemia in hospital settings and many such events are preventable, there is currently no measure in a CMS quality program that quantifies how often hypoglycemic events happen to patients while in inpatient acute care.”
In August, the Centers for Medicare and Medicaid Services updated its Hospital Inpatient Quality-Reporting program, measures aimed at tracking and improving practices of appropriate glycemic control and medication management of patients, as well as avoiding patient harm leading to increased risk of mortality and disability. Hospitals have from now until January 1, 2023, to pick from 11 different Electronic Clinical Quality Measures (eCQMs) on which to report. (Two of the 11 measures are for hypoglycemia and hyperglycemia.)
Physicians and industry leaders alike seem to be amenable to and even excited about the changes. Jordan Messler, MD, SFHM, FACP, chief medical officer at Glytec, an insulin management software company that helps healthcare providers improve the quality and cost of care in Waltham, Mass., sees these new measures improving care across the board. Even though adopting these eCQMs will initially be elective, Messler sees them as the extrinsic motivator, the regulation that will drive change and make hospital administrators aware of the fact that endocrinologists and glycemic management teams need more resources, like diabetes educators. “It’s going to get us metrics,” Messler says. “That’ll be consistent once these eventually get reported in 2024. [From the hospitals that decide to report] we’ll have some metrics here that are national benchmarks. We don’t really have that in the glycemic space. It’ll raise awareness from now on as long as metrics exist.”
“I’m thrilled,” says Mihail “Misha” Zilbermint, MD, FACE, associate professor of Clinical Medicine at Johns Hopkins School of Medicine and endocrine hospitalist at Suburban Hospital in Bethesda, Md. “I know that inpatient glycemic management has not been recognized.”
Zilbermint had already been the point person for reporting and coming up with action plans at Suburban, and he and his colleagues had already implemented their own Glucose Steering Committee and Inpatient Diabetes Management Service, which saw reduced rates of hypoglycemia and hyperglycemia, as well of length of stay and hospital costs, (see the June 2021 issue of Endocrine News) so the team at Suburban may be ahead of the curve, but that doesn’t mean they can rest on their laurels here. Six years ago, Suburban Hospital had one of the highest rates of hypoglycemia in the entire Johns Hopkins Health system. They’ve since improved, due in large part to the aforementioned steps, but Zilbermint says the biggest challenge for hospitals now with these new CMS rules will be the “nitty gritty implementation on the ground.”
For some hospitals, it may play out this way: The hospital will report the metrics, the hospital brass will see something that needs to be addressed or corrected and call the community endocrinologist in only for the endocrinologist to say, “Yeah, I’ve been telling you this for 10 years.”
Told-you-so situation or not, Zilbermint says these new measures will mean more resources for patient education, and he sees hospitals incorporating endocrine hospitalists and creating more positions in the endocrine and diabetes care spaces, which could mean big things for the specialty of endocrinology as a whole. Until now, hospitals hadn’t recognized the importance of endocrine hospitalists, assuming diabetes care can be done in an outpatient setting. A problem of supply and demand. “I think that the endocrinology fellowship will invest more in training = the future generation, focused on the inpatient glycemic management,” he says. “So we will increase the supply.”
This process may take years, and Zilbermint says that won’t be an easy process, and there might not be immediate results, but he hopes providers won’t get discouraged. “If you take small steps going the right direction,” he says, “I think you’re going to win big in those metrics, but also ultimately help the patients.”
- Bagley is the senior editor of Endocrine News. In the October issue he wrote about the unusually high rates of fatty liver disease in Mexican American populations compared with other Hispanic American populations.
– This article originally appeared on Endocrine News.
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