Diabetes Technology Focuses on Device Interoperability

A series of recent FDA actions reflect a desire to meet consumer demands for ease of diabetes product use across multiple platforms, and more..

Wireless Artificial Pancreas System Talks to Other Diabetes Devices

The increasingly data-driven diabetes device category has been linked to improvements in disease outcomes.1 Certainly, the greater ease of data sharing between patients and their families and clinical practices has improved feedback and led to better glucose self-management. However, these devices have had limited interoperability, revealing the biggest detraction for patients and offering the newest area of opportunity to advance this technology.

Interoperability has been cited as a highly desirable feature for artificial pancreas systems to fulfill the full range of patient needs for long-term glucose management,2 according to Eyal Dassau, PhD, director of the Biomedical Systems Engineering Research Group at Harvard University, and adjunct faculty at the Joslin Diabetes Center in Boston, Massachusetts.

Walkers test interoperability of wireless artificial pancreas system.

The researchers initiated this investigational device exemption study to assess the safety and efficacy of a smartphone app in conjunction with an interoperable wireless artificial pancreas system (iAPS).2

This iAPS system was designed to network with an ever-growing assortment of diabetes devices, including continuous glucose monitors (CGM), insulin pump devices, and decision-making (artificial intelligence-driven) algorithms.2

“We are currently using the iAPS system in an outpatient study with 10 adults in Santa Barbara, as well as in an ongoing hotel study in pediatrics at Yale University in which the kids are using this system,” Dr. Dassau told EndocrineWeb.

Wireless Artificial Pancreas System Trialed in Real-World Setting 

Participants challenged the functionality of the AP system by performing extensive walking without exercise declared, multiple large restaurant meals, two overnight sessions, and several intentional connectivity interruptions.

“During the study, participants did a one-hour schedule brisk walk in addition to eating around the town of Santa Barbara throughout the weekend,” Dr. Dausau said.

Despite the planned challenges, the participants in this initial evaluation of the iAPS, comparison of the artificial pancreas phase, compared to the sensor-augmented pump phase, showed a trend toward improved glucose time in range (70-180 mg/dL [78.8% vs. 83.1%; P = 0.31]) with a statistically significant reduction in time below range (hypoglycemia: < 70 mg/dL [6.1% vs. 2.2%; P = 0.03]).2 The study results were published in Diabetes Technology & Therapeutics.

The ease of use—operating on an unlocked smartphone—the iAPS system demonstrated both good reliability and good connectively with peripheral devices (99.8% connectively with CGM; 94.3% with closed-loop devices).2

The findings supported the safety and efficacy of this app-driven system in regulating blood glucose “with robust connectivity and no adverse events in the presence of large meals and unannounced exercise.” While the app required limited user interactions, the range of notifications was kept broad enough to support all prerequisites for patient safety.

The conclusion, according to Dr. Dessai and his team, was that the iAPS system achieved the desired endpoints in regulating glucose levels under real-life challenges and normal use conditions, making the iAPS system suitable to support the needs of people with diabetes. 

Our research team has plans for a larger outpatient trial, which is under development with two multicenter studies, said Dr. Dassau.

FDA Actions Open More Opportunities for Diabetes Devices

Next Generation Closed-Loop Artificial Pancreas Moves Closer to Market

The personalized, closed-loop insulin pump system, under development by Medtronic, received breakthrough device status from the Food and Drug Administration (FDA).3 This diabetes management device was developed to deliver insulin through a fully automated and adaptable real-time medication delivery system.

Intended to simplify diabetes self-care, gaining this designation grants the company priority review in the planning and presentation of its device development, clinical trial efforts, and plans for a product launch.

t:Slim Insulin Pump Receives FDA Nod for Interoperable Advance 

The FDA granted 510(k) clearance to Tandem Diabetes Care to permit the launch of the t:Slim X2 insulin pump, a new type of interoperable system—an alternate controller enabled (ACE) infusion pump. The t:Slim X2 is intended for seamless use with compatible diabetes devices, such as automated insulin dosing (AID) systems, continuous glucose monitors, blood glucose meters, and other electronic devices designed for diabetes management.4

This FDA action also established a new regulatory classification for all future ACE-type insulin pumps to receive expedited 510(k) review in seeking to gain marketing clearance. 

PROMISE TRIAL Initiated to Evaluate 180-Day Eversense Sensor 

To gain approval for long-term placement of the Eversense XL sensor to expand the current 90-day implant time, Senseonics has initiated this clinical trial to gain premarket approval to allow for doubling the implant time of their continuous glucose monitoring system—as has already been approved in Europe.5  

The goal is to meet patient demand for maximum placement allowing for extended use, the company enrolled the first of an anticipated 180 patients across 15 centers in the US to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes.

Additionally, Senseonics submitted a PMA supplement to secure an insulin-dosing claim and to have the FDA remove the contraindication regarding exposure to magnetic resonance imaging (MRI) for the Eversense 90-day implant.5

“Our submission of the supplements to secure the dosing claim and to remove the magnetic resonance imaging contraindication for the current 90-Day Eversense system are significant step forward in reducing the burden of diabetes management and providing patients peace of mind,” said Tim Goodnow, President and Chief Executive Officer of Seneonics in a company-issued statement. 

On Another Topic—
Clinician-based Medical Cannabis Efficacy Portal Launched

A free tool to facilitate the sharing of efficacy and outcomes data for patients who have been prescribed medical cannabis. Developed by Arlinn Med, a medical education agency, the aim is to coordinate physician experiences by tracking, reporting and communicating HIPAA-compliant benchmark data following the prescribing of medical marijuana for patients. As a free tool for physicians, Arfinn Med offers a new way to enhance patient treatment planning and more informed practice in an emerging industry.  

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