Research Advances and Diabetes Device Development to Watch for in 2019

A brief overview of several technology enhancements and clinical practice tools to watch for and consider using in the coming months—January edition.

The future of diabetes management is evolving with two main themes —prevention and patient-centered care, as reflected in our reporting.
 
As diabetes technology evolves at breakneck speed, the Food and Drug Administration has been granting clearance for device enhancements and new products that promise to ease the burden on clinical practices and allow for greater patient self-management.
 

Patient adherence to insulin regimens is likely to improve with advances in medication delivery and supportFDA diabetes device approvals, Improved injectable insulin pens, and proof that virtual coaching is beneficial. Image: 123rf

Improved Glucose Sensor Functionality Supersedes Finger Stick Checks

In two recent studies,1,2 the development of a coating added to the prong of subcutaneously placed glucose sensors promises vast improvements in the experiences of individuals requiring insulin to manage their diabetes.  

Patients’ desire for extended use, implantable glucose devices is growing, particularly among individuals who have opted to use a continuous glucose monitor (CGM). Until now, nearly all of these patients were likely to experience a local immune reaction arising at the location of the sensor implantation site, leading to several common adverse side effects including inflammatory tissue response, delayed wound healing, the formation of fibrosis, and signal noise.1,2

A research team, led by Daniel G. Anderson, PhD, associate professor of chemical engineering at the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology, developed a coating for these subcutaneous sensors to both reduce tissue inflammation and the “noise” that necessitates initial finger stick calibrations with the continuous glucose monitors to confirm accuracy.  

“The signal produced by CGMs during the initial recording period following sensor implantation contains substantial noise, requiring frequent recalibration via finger-prick tests,” the authors wrote at ResearchGate.

Here, we show that coating the sensor with a zwitterionic polymer, found via a combinatorial chemistry approach, significantly reduces signal noise and improves CGM performance,1 they reported in Nature Biomedical Engineering. The researchers suggested that the inflammatory response to CGM sensor materials has been the likely cause behind signal fluctuations following implantation.

These early immune-mediated reactions may explain the limits to full functionality of subcutaneous glucose sensors, and worse, may have contributed to device failure. To address these concerns, the engineering team was able to demonstrate that by applying a zwitterionic polymer coating to sensors, they were able to achieve a reduction in the inflammatory response and in signal noise, leading to improved outcomes and less need for recalibration.1  

These polymer-coated sensors were tested in healthy and diabetic animal models, demonstrating that the sensors accurately record glucose levels without the need for recalibration. 

“We also show that the coated sensors significantly abrogated immune responses, as indicated by histology, fluorescent whole-body imaging of inflammation-associated protease activity and gene expression of inflammation markers,” said the authors. It appears that the polymer coating may allow CGMs to function as standalone measuring devices.  

“The signal produced by CGMs during the initial recording period following sensor implantation contains substantial noise, requiring frequent recalibration via finger-prick tests,”2 according to Zhiqiang Cao, PhD, professor of chemical engineering and Ershuai Zhang, PhD, professor of medicine at Wayne State University in Detroit, Michigan. “Here, we show that coating the sensor with a zwitterionic polymer, found via a combinatorial chemistry approach, significantly reduces signal noise and improves CGM performance,” they wrote.

Value of Virtual Coaching Gains Further Backing

Building on reports of the favorable outcomes seen in patients trialing a virtual coaching program, patients who engaged with a digitally-based health coach as an integral part of their medical care plan gained the greatest benefits from using a wearable device,according to findings published by the Healthcare Information and Management Systems Society (HIMSS).

The HIMSS study compiled responses from 100 information technology experts regarding the level that health professionals have integrated wearable diabetes devices into their practices, including the review of patient-generated health data. 

When faced with downloading and reading data from patient devices, most commonly CGMs, this was considered both a time burden and a hindrance to office workflows.3

However, the data analytic tools and smartphone apps have become much more efficient such that most diabetes specialists are now embracing patient use of, even recommending, these glucose monitoring devices, and viewing them as an advantage in fostering patient learning and self-care as well as enhancing clinical care.

The report was underwritten by funding from Fitbit.

Advances In Insulin Pens Promise Better Outcomes

Game-Changing Naturally Contoured Needle Design Ready for Market

The Food and Drug Administration  (FDA) granted 510(k) clearance to Becton Dickinson for its BD Nano ergonomic pen needle aim at patients with diabetes.4 The new design of this insulin injection device provides a more reliable insertion depth.  

“We are very pleased with the FDA clearance of the BD Nano second generation insulin pen needle. This product has been designed to make the injection experience convenient and efficient,” said Stanislav Glezer, MD, MBA, global vice president of medical affairs for BD.

According to the FDA statement,the pen needle has a contoured needle base that concentrates and then distributes pressure closely around the injection site to give more reliable injection depth.

“The cannula features a 5-bevel tip to penetrate the skin easily and painlessly, and the hub is wide and easy to handle. An advantage of this design is that the hub goes flat against the skin, evenly distributing the pressure that the patient applies, thereby reducing variability in injection depth and keeping it consistently at 4mm in subcutaneous tissue,” he told EndocrineWeb.

The FDA panel anticipates that the improved patient experience will facilitate more consistent insulin dosing given a reduction in the risks that have been an obstacle to adherence to date as a result of varying user injection force, leading to better diabetes self-management.4

InPen System for Android Now Available

An Android version of Companion Medical’s InPen App nears launch, extending access of the first smartpen system to all smartphone users.5 The InPen system has been commercially available for people with iOS devices since December 2017 and is the only FDA-cleared, smart insulin pen paired with an integrated diabetes management app.

"Our mission is to empower people living with diabetes and their healthcare providers with easy-to-use connected solutions that improve outcomes at a lower cost,” said Sean Saint, chief executive officer of Companion Medical. With diabetes, it is about taking the right amount of insulin at the right time, which is facilitated by the built-in dose calculator, insulin-on-board tracking, and dose monitoring and personalized reminders, while also sharing data with healthcare providers.

The release of the Android App will extend the InPen capabilities to a wider group of individuals to help those with diabetes to better manage their insulin dosing and provide physicians with accurate real-time data. For example,

the InPen reports display aggregated glucose, insulin, and meal data with detailed daily views, allowing for more accurate monitoring of glucose control and adherence patterns, identification of cause-and-effect impact of food and insulin decisions, which offers a chance at more targeted self-improvement of diabetes control.

“These features can help patients make better decisions about how and when to treat their diabetes, help to reduce some of the challenges with glucose management, and reduce the burden of living with diabetes,” said Mr. Saint.

InPen is only available by prescription.

AACE Launches  Cardiovascular Disease Resource

In recognition of the growing challenge that endocrinologists face with the concomitant conditions—diabetes and cardiovascular disease— that intersect, co-exist, and increasingly require co-management, EndocrineWeb has made this a key focus of our reporting. 

To aid healthcare providers in keeping abreast of best practice recommendations, the American Association of Clinical Endocrinologists (AACE) has launched an online Lipids Resource Center, which brings together evidence-based guidance on patient screening, risk assessment and treatment options in an easily accessible collection of clinical guidelines, recent journal articles, and slide presentations to help you stay current in this ever-evolving intersection of lipids, cardiovascular disease, and diabetes management.

The need for this resource grew out of AACE’s success in making two other disease-focused resources centers available to its members—one featuring clinical care guidance on diabetes and a second focused on obesity resources.

A sampling of the topics to be addressed in the Lipids Resource Center include managing hyperlipidemia, when or if to prescribe new lipid-lowering therapies (ie, PCSK9 inhibitors), addressing hypertriglyceridemia, and atherosclerotic cardiovascular disease (ASCVD) risk.6

Look for more resources to be added to the website:

  • Toolkit of downloadable patient education materials featuring strategies for good self-care and optimal disease management
  • Links to additional patient resources, and
  • Continuing education programming—both live and web-based  

“The AACE Lipids Resource Center will not only serve AACE’s practicing endocrinologists but also has been designed as a go-to, open-access platform offering the meaningful information sought by those in the health care arena who care for those with lipids disorders,” said Chris Guerin, MD, FACE, chair of the AACE committee that spearheaded development the AACE Lipids Resource Center in statement issued by the organization.  

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