Will the Surge in New Diabetes Devices Improve Patient Outcomes?

Given the avalanche of app approvals, product updates, and study findings, here’s what to watch for as the future of clinical diabetes management unfolds.

With Gail L. Nunlee-Bland, MD, Israel Hodish, MD and Richard Bergenstal, MD,
and commentary by Elena A. Christofides, MD

iGlucose Solution Improves Glycemic Control in High-Risk Patients

A three-month study was conducted to evaluate the efficacy of monitoring serum glucose remotely in an urban, Medicare/Medicaid-based population.1 It was designed in response to a recognized opportunity to employ a simple glucose capture device—the iGlucose Cellular Diabetes Care Solution (Smart Meter)—to improve patient diabetes self-management through the exchange of real-time actionable data, according to the investigator, Gail L. Nunlee-Bland, MD, director of the Howard University Hospital Diabetes Treatment Center in Washington, DC.

Clinicians need to know their way around new diabetes technology.  New diabetes devices may assist patients in improving their glucose levels and in communicating with their providers.Photo:123rf

“We were seeing blood sugars at 35 mg/dL and 40 mg/dL in the ER, yet these patients didn’t call us when problems arose, and this is a population that could not be bothered with high tech gadgets,” said Gail Nunlee-Bland, MD, director of the Diabetes Treatment Center at Howard University Hospital in Washington, DC. 

“I considered this device as a good fit for our population because many times patients didn’t bring their [glucose] meters or log books to visits so it was hard to properly assess their diabetes status. With this device, they didn’t have to do anything—there weren’t any cables required to connect the phone to the computer to upload data, they didn’t have to log in, or need to have a Bluetooth-enabled device. These were factors that limited the sharing of individual glucose data,” said Dr. Nunlee-Bland.

“We randomly recruited 41 patients deemed at high risk who attended our clinic for diabetes management to use the iGlucose Cellular Diabetes Care Solution instead of the glucose meter they were using,” she said. The participants, ages 18 to 85 years, reflected the spectrum of the disorder—type 1 diabetes, type 2 diabetes, and gestational diabetes.1

Results of iGlucose Use on HbA1c in Selected Patients

“I found that one of the best features of this system was our ability to send a text directly to the patient’s glucose meter with recommended insulin dosing and lifestyle changes, eliciting an immediate response, Dr. Nunlee-Bland told EndocrineWeb, “which was a distinct advantage over an email or phone calls that were often missed, forgotten, or ignored.”

Another advantage was the automatic loading of data, low-tech nature of this device, which worked for patients of all ages because it didn’t require them to log-in to record blood glucose levels, she said. "Based on the study findings, the iGlucose system proved beneficial in a high-risk population given demonstrated success in lowering the average hemoglobin A1c (HbA1c) by 2.8% in a majority of those with a baseline value over 9%. "

More than 70% of participants required some form of intervention prior to their next in-office visit, and as a result, there was a reduction in emergency room visits and need for hospitalizations, demonstrating better overall diabetes care, reported Dr. Nunlee-Bland.

“Patients liked this device because it sent them timely reminders, which made them feel more cared for since they were being constantly monitored; this, in turn, motivated them to respond to prompts. Also, clinicians received the glucose readings in real-time, permitting quicker intervention, as needed," she said.

In a post-study survey of participants, Dr. Nunlee-Bland said, three-quarters of our patients responded that the iGlucose device made it easier to discuss their diabetes status with their provider and to share glucose readings (78% and 76%, respectively), 60% felt the iGlucose was easier to use than the diabetes monitor they were using before this study, and more than half (51%) reported greater ease in reviewing their blood glucose trends. 

Improving Diabetes Care Requires Ease of Data Sharing

“We need to meet the patients where they are,” said Dr. Nunlee-Bland. “Most of our patients, won’t use a diabetes monitoring device that requires them to log in. Even then, they typically ignore our emails and cell phone calls. With the iGlucose system, we were able to receive and monitor their glucose levels and send a text directly to the meter, which elicited an immediate response. This proved to be a convenient and affordable diabetes care solution for our patients.”

There are seven endocrinologists, two nurses, and a doctor of pharmacy (PharmD) in the Howard Hospital practice, who typically checked in at least once weekly to review the data sent by each patient, except those viewed as high-risk whose glucose levels were checked more often, essentially addressing patient care individually,” she said.

In surveying the providers, they unanimously endorsed the use of the iGlucose diabetes device in making it easier to receive and review data in just five minutes, she said. “There was general agreement among the patients and the clinicians that the diabetes care was more personalized and individualized so we are looking to continue the use of this glucose monitoring system in our practice.”

d-Nav Addresses Key Need for People with Diabetes

The d-Nav Insulin Guidance Service app—developed by Hygieia to act as the first personalized insulin-titration device —received 501(k) clearance from the Food and Drug Administration (FDA).2 Relying on a built-in algorithm that has the capability to interface with any blood glucose meter transmitting data to the cloud, the d-Nav app was cleared in recognition of its ability to optimize insulin management by calculating individualized insulin doses delivered directly to the patient for immediate use.

Understanding why people with T2D usually so not achieve ideal glucose levels on insulin is a nagging question. “It is usually because the insulin doses need to be changed on a regular basis (ie, weekly), forever, and there are so many factors that affect [blood] glucose—food, exercise, stress, work, seasons, among others, so the insulin dose is never stable but usually only gets assessed maybe 2-3 times a year,” said Richard  Bergenstal, MD, clinical professor of medicine at the University of Minnesota, and Executive Director of the International Diabetes Center at Park Nicollet Health Sciences.

“To overcome this, the d-Nav system measures blood glucose levels, stores the data, and constantly reviews the patterns used to recommend a new dose of insulin when trends reveal a need to increase or decrease the current dose," Dr. Bergenstal said.

While motivated patients may achieve this by keeping track of all their sugars and insulin doses in a log book, reviewing them weekly, adjusting accordingly, few will achieve this long-term; the dNav system will do it for them, Dr. Bergenstal. And only 30% of patients with type 2 diabetes in the US are at goal so there is clearly a need to help the vast majority of patients who aren't doing well.

Does the d-Nav Measure Up in Clinic Testing?

A six-month, randomized multicenter controlled trial was initiated in three US diabetes centers to evaluate whether use of the d-Nav system by patients with insulin-treated type 2 diabetes was superior to standard care alone in adults; findings of this prospective, open-label study appear online in Lancet

Understanding why people with T2D usually so not achieve ideal glucose levels on insulin is a nagging question. “It is usually because the insulin doses need to be changed on a regular basis (ie, weekly), forever, and there are so many factors that affect [blood] glucose—food, exercise, stress, work, seasons, among others, so the insulin dose is never stable but usually only gets assessed maybe 2-3 times a year,” said Richard Bergenstal. 

“To overcome this, the d-Nav system measures blood glucose levels, stores the data, and constantly reviews the patterns used to recommend a new dose of insulin when trends reveal a need to increase or decrease the current amount.3

Patients with a body-mass index of 45 kg/m² or higher or complications including severe cardiac, hepatic, or renal impairment as well as three or more severe hypoglycemic events in the past year were excluded. Patients (n = 181) with HbA1c between 7.5% and 11% on insulin for three months were assigned to either d-Nav with healthcare support or standard clinical support alone.3

The primary objective was to compare the average change in HbA1c. The mean decrease in HbA1c from baseline to six months was 1.0% (SD 1·0) in the intervention group, and 0.3% (SD 0·9) in the control group (P < 0·0001).3

Overall, the insulin dose was adjusted 1.1 times weekly (SD 0.2), which is a rate of adjustment that is feasible in usual clinical practices. More notable, the greater frequency of insulin corrections led to doses that were 60% higher than in the control group. About 15% of the changes in insulin titration were for lower doses.3

While motivated patients may attain tight glucose control by keeping track of all their sugars and insulin doses in a log book, reviewing them weekly, adjusting accordingly, few will achieve this long-term; the dNav system will do it for them,3 according to Dr. Bergenstal who led the clinical trial to assess the efficacy of the dNav device in clinical practice.

"You always have to watch for low glucose and weight gain in your patients T2D when using insulin; these were both at minimal and acceptable levels in among the patients using the dNav in our study," Dr. Bergenstal told EndocrineWeb. 

What Would Prompt Adoption of the dNav?  

“Achieving such a dramatic decline in HbA1c in the intervention group offers strong support for the adoption of a smart titration system that is better able to achieve adherence and a significant reduction in overall glucose levels,,” said Elena A. Christofides, MD, clinical associate professor, at Ohio University College of Medicine, and CEO of Endocrine Associates in Columbus, “which promises to meet an important clinical need—to simplify and individualize insulin dosing that promotes patient self-care.” 

This app encompasses insulin-titration algorithms designed to be responsive to individual patient glucose readings. Paired with the d-Nav service, which includes an app for both iOS and Android smartphones—this diabetes glucose management tool is intended to make insulin management more efficient, less time intensive, and more cost-effective, Israel Hodish, MD, associate professor of medicine and director of the Intensive Type 2 Diabetes Program at the University of Michigan as well as co-founder and clinical research lead for Hygieia told EndocrineWeb

“That said, one problem with the study is that the algorithms used in the device are proprietary, making it difficult to fully assess the data. Once the d-Nav is deployed on a wider scale for longer periods of time, we will be better able to determine its true functionality,” Dr. Christofides told EndocrineWeb.

“Given its promise, if the d-Nav stands up to time, I can imagine the potential for adoption of this diabetes tool by Medicaid systems and hospital formulary groups who will, in turn, incentivize clinical practices to adopt it,” she said.

Dr. Hodish explained some of the features specific to d-Nav in response to questions raised by EndocrineWeb.

  • “All data pertaining to patients’ glucose and insulin doses are accessible by their providers;
  • It can be used by most patients using insulin to manage their T2D unless achieving glycemic goals are not in their best interest (eg, patients with a short life expectancy); and
  • The app uses either a manually entered glucose value or it can automatically use a glucose measurement taken by the meter that has icloud transmission capability.” 

At present, the d-Nav service is permitted for use at no cost to patients in Southeast Michigan who have type 2 diabetes and health coverage through Blue Cross Blue Shield of Michigan (BCBSM). The company is exploring opportunities to expand the d-Nav service in the US.

“Several U.S. health plans in addition to BCBSM are currently considering offering the d-Nav Service to their members. Hygieia will continue to provide updates as these plans come on board, Hygieia’s CEO Eran Bashan told EndocrineWeb.

Insulin Pen Adds Diasend Platform and CGM to Improve Functionality

A launch is planned for the first connected insulin pens—NovoPen 6 and NovoPen Echo Plus—in the next quarter. These next-generation insulin injectable devices (Novo Nordisk) are compatible with the diasend shared-capture data platform (Glooko).4

Until now, sharing data from insulin pens was limited to self-report, which was subject to human error or not recorded. To expand the use and exchange of data between patients and their clinicians, patients will have the ability to upload their insulin pen data remotely—straight from any near field communication-equipped Android phone running the diasend mobile app.

Having this enhanced devise coordination will facilitate a more seamless syncing of real-time patient glucose levels, allowing for better-informed conversations and facilitating more timely and responsive adjustments to the patient’s treatment plan,4 according to the company.

In addition, the diasend system will now be compatible with the Dexcom G6 continuous glucose monitoring (CGM) device so patients using these products will have the option to either upload data to the diasend platform in the doctor’s office or by syncing the data continuously with a cloud-to-cloud connection through the Dexcom Clarity system.4

To assess the functionality of this interconnected system in enhancing diabetes management, patients were enrolled in a pilot study to trial use of three diabetes devices: this next generation insulin injectable pen with the diasend data sharing system and the Dexcom G6 continuous glucose monitor (CGM); the results were  previewed at the Advanced Technologies & Treatment for Diabetes (ATTD) meeting in Berlin.

Perspective on Adopting News Diabetes Devices

We are seeing an explosion of technology and studies in the diabetes space, with every one of these devices aimed to capitalize on the challenges of time with regard to patient adherence and supervision, said Dr. Christofies. These devices are being designed to create an additional layer of glucose testing which may explain why it is that the accelerated FDA approval process and favorable studies results show favorable results.

To be adopted, a new diabetes device will need to touch the patient in a manner that works on their time and at home. Any of these will be adopted in a side ranging manner, she said.

“Most of our patients with diabetes who are inclined to adopt technology are already using devices or have created their own so the buy-in and engagement are already established, making the likelihood of any interest in switching low,” said Dr. Chistofides.

This is especially true among the baby boomers who are already bogged down with multiple medications and devices required to manage the myriad chronic diseases—CVD, hypertension, hyperlipidemia—they are facing beyond type 2 diabetes. As such, the suggestion that they adopt more equipment is likely to e med with resistance to any further intrusions regarding their health care management.

“As I see it, any news devices and enhancements are more likely to come into their own as the next generation ages in to diabetes care management since they are more desirous and open to technology as a way to problem solve, so we should take the long view on patient acceptance and use of these new diabetes devices,” said Dr. Christofides.

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