Trending Clinical Topic: Insulin

Ryan Syrek


September 16, 2022

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From a new US Food and Drug Administration (FDA) approval to promising research findings and ongoing debates over cost, news related to insulin led to increased interest in this important hormone. Some experts believe that automated insulin delivery represents the "next generation of research" in diabetes technology. On August 22, the FDA expanded the approval for the Omnipod 5 (see Infographic).

In January, the device was cleared for use in persons aged 6 years or older. It is the third semiautomated closed-loop system approved in the United States and the first that is tubing-free. The Omnipod 5 integrates with the Dexcom G6 continuous glucose monitoring system and a smartphone to protect against high and low glucose levels by automatically adjusting insulin. A clinical trial in children aged 2-5.9 years found that the device increased the time spent in target glucose range (70-180 mg/dL) by 11% (2.6 hours more per day).

The future of automated insulin delivery systems is exciting to many in the field. According to Greg Forlenza, MD, who works at the Barbara Davis Center for Childhood Diabetes in Colorado, "This next round of research will involve systems that use cloud-based, real-time tuning of systems." The goal is that the new devices won't require provider expertise to fine-tune systems but will use cloud-based data to provide feedback on what adjustments are needed in real time. The hope is that this will allow patients with diabetes increased flexibility. As Forlenza explained, "For users who want to take a step back, want to take a break from diabetes for a few days, want to go out on a Friday night and be like their peers, the systems will be able to provide automated meal dosing in a way that is robust…the level of control that will be achieved by the system alone will be very acceptable and better than the average control was 10 years ago."

Excitement about developments for patients with type 1 diabetes in particular is growing. Aaron J. Kowalski, PhD, CEO of JDRF, says that advances in insulin delivery are crucial. "Today, in 2022, we have three commercially available systems (Medtronic, Insulet, and Tandem), and we have what we call do-it-yourself systems that people have put together, built their own algorithms, that allow people to control their diabetes off their cell phones." Like Forlenza, Kowalski sees the benefits extending beyond just glycemic control. "We have to appreciate that there's more to life than diabetes. Hybrid closed-loop systems help improve our quality of life, whether it's sleeping through the night, fewer alarms, or less anxiety about lows."

Beyond delivery systems, emerging research could herald a new therapeutic era for type 2 diabetes. Targeting insulin resistance, as opposed to hyperglycemia, may be key. Findings involving a biologic called PATAS suggest that focusing on the mechanism that underlies type 2 diabetes is an intriguing strategy. PATAS, which stands for "peptide derived from PKC alpha targeting ALMS," treats the source of type 2 diabetes. It is the first of a novel class of drugs called "adipeutics," which address insulin resistance. In animal studies, PATAS has been shown to restore glucose absorption in the dysfunctional adipocyte. According to researchers, "liver steatosis and fibrosis were considerably reduced in all diabetic animal models tested, including in one of the reference models for fatty liver disease, namely the Japanese STAM mouse model. Thus, PATAS reduced hepatic steatosis by 60% and hepatic fibrosis by 40% after only one month of treatment at a dosage of 2 mg/kg/week." A phase 1 clinical trial is planned for 2023.

Despite advances in insulin-related research, concerns about cost remain. Thankfully, in January, the cost of insulin for patients on Medicare will be capped at $35 a month. This will help around 2 million people who currently pay an average of $572 annually out-of-pocket for insulin. Approximately 7 million Americans require daily insulin, and 14% of those individuals spend almost half of their income (after food and housing expenses) on insulin. Although relief is coming for some, those who will not benefit from the cap continue to express worry about pricing.

Between promising developments and familiar concerns, a wide range of news about insulin resulted in its becoming this week's top trending clinical topic.

Learn more about type 1 diabetes.


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