As 2024 begins to draw to a close, the fields of endocrinology and diabetes management find themselves on track for a record pace for headlining news and historic breakthroughs. The month of September continued the trend seen throughout the preceding months, including August 2024, which saw the release of paradigm-shifting data for finerenone and semaglutide, the launch of the first over-the-counter (OTC) glucose sensor in the US, and the ADCES 2024 meeting.

In our endocrinology month in review for September 2024, we highlight a trio of regulatory updates from the US Food and Drug Administration (FDA), popular news and headlines related to comorbidity management, and the latest episodes of our flagship diabetes podcast, Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives.

FDA News

Embecta’s 300U Patch Pump

On September 03, 2024, Embecta Corporation announced the FDA had granted 510(k) clearance for their disposable patch pump for insulin delivery for use in adults who require insulin to manage diabetes. Including both 1 and type 2 diabetes within this indication, the FDA clearance means patients will have access to a tubeless patch pup boasting a 300-unit insulin reservoir designed based on feedback from people with type 2 diabetes and healthcare providers. In their release, Embecta pointed out patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission.

FDA Clears Eversense 365, Marking First 1-Year CGM Option in Diabetes

2024 represents the beginning of a new age in diabetes technology, specifically glucose monitoring. On September 17, 2024, Ascensia and Senseonics announced the FDA clearance of the Eversense 365 system—the world’s first 1-year continuous glucose monitor.

A fully-implantable, long-term CGM option, the Eversense 365 will feature a silicone-based adhesive that can be changed daily, a removable transmitter that can be taken on and off without wasting a sensor or adding a warmup period, and on-body vibration alerts to keep patients notified when away from their phone. Ascensia and Senseonics pointed out Eversense 365 had been cleared as an integrated CGM system, which allows for integration with compatible medical devices, including insulin pumps as part of an automated insulin delivery system.

TransCon hGH Aims for FDA Label Expansion for Adult Growth Hormone Deficiency

On September 30, 2024, Ascendis Pharma announced it had submitted a supplemental Biologics License Application to the FDA for TransCon hGH (lonapegsomatropin) for the treatment of adults with growth hormone deficiency (GHD). According to Ascendis, this application is support by results from the Phase 3 foresiGHt trial, demonstrating the superiority of weekly TransCon hGH on primary efficacy and key secondary efficacy endpoints compared with placebo.

Headlines in Comorbidity Management

ASN Releases New Guidance on Obesity Management in Kidney Disease

On September 18, 2024, the American Society of Nephrology has released its inaugural Kidney Health Guidance on the Management of Obesity in Persons Living with Kidney Diseases, providing nephrologists and other kidney health professionals with an overview of the existing tools for obesity management and guidance on their implementation in clinical practice.

The guidance, which focuses on patients aged 18 years or older living with obesity and kidney disease and emphasizes the importance of individualized health and weight loss goals; the need for a multidisciplinary kidney care team to optimize outcomes; and the use of a combination of multiple interventions to achieve and sustain safe weight loss.

Semaglutide Benefits Quality of Life in Hidradenitis Suppurativa Treatment

Data presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024 suggested patients with obesity achieved significant improvements in quality of life and fewer disease flare-ups when semaglutide was added to standard hidradenitis suppurativa therapies.

A retrospective analysis of 30 patients followed for a mean of 8.2 months, resulted suggested initiation of semaglutide was associated with a decrease in frequency of flare-ups from once every 8.5 weeks to once every 12 weeks and a reduction of the DLQI score from 13 of 30 to 9 of 30 (95% CI, 1.696 to 10.68; P = .0014).

GLP-1 RA Linked to Lower Risk of Cirrhosis Development in Patients with MASLD

A propensity score matched study of new GLP-1 RA users compared the risk of cirrhosis development and cirrhosis complications among patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and type 2 diabetes from the VHA Corporate Data Warehouse.

Among MASLD patients without cirrhosis, GLP-1 RA use, compared with DPP-4i use, was linked to a lower cirrhosis risk (9.98 vs 11.10 events per 1000 person-years; hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.75 to 0.98). Investigators observed similar results with secondary outcomes, with GLP-1 RA use linked to a lower risk of the composite outcome of cirrhosis complications (1.89 vs 2.55 events per 1000 person-years; HR, 0.78; 95% CI, 0.59 to 1.04) and mortality (21.77 vs 24.43 events per 1000 person-years; HR, 0.89; 95% CI, 0.81 to 0.98). There were no associations between GLP-1 RA use and outcomes in patients with cirrhosis.

Don't Miss a Beat: Putting Evidence-Based Cardiometabolic Therapies into Practice, with Taher Modarressi, MD

In this episode of Don't Miss a Beat, hosts Muthiah Vaduganathan, MD, MPH, and Steve Greene, MD, sit down with Taher Modarressi, MD, a cardiometabolic health specialist, to discuss the practical challenges of integrating cardiometabolic therapies into clinical practice.

Modarressi, who launched and owns a standalone practice in the Princeton, NJ area, shares his perspective on his career, what led to establishing the clinic, and the steps he takes to ensure the successful implementation of new therapies, such as GLP-1 receptor agonists and SGLT2 inhibitors, for complex, chronic conditions, including diabetes, obesity, and cardiovascular disease.

Diabetes Dialogue

Diabetes Dialogue: Real-World Experience with the Dexcom Stelo

In a follow-up to a previous episode where hosts offered their initial reactions after using the Dexcom Stelo for 24 hours, Isaacs and Bellini reconvened to offer further perspective on their experiences with the OTC glucose sensor. During the episode, hosts praise the app's educational "nuggets" and the spike detection feature, which prompts users to reflect on potential causes of glucose changes. Bellini notes her appreciation of the app's ability to ask questions about real-time glucose fluctuations, highlighting how this could provide valuable insights to consumers, and Isaacs calls attention to the app's 15-minute data updates, though the underlying data is available every 5 minutes. Later in the episode, hosts discuss some of the early drawbacks of the system.

Diabetes Dialogue: Lingo Availability and FDA Clearance for Embecta's Tubeless Patch Pump

In this episode, hosts broke down a pair of announcements related to diabetes technology: availability of Abbott’s Lingo and clearance of Embecta’s tubeless patch pump.

On September 05, 2024, Abbott announced US availability of their own OTC glucose monitor, the Lingo. Designed for consumers 18 years and older not on insulin, is priced at $49 for 1 biosensor worn for up to 14 days or $89 for 2 biosensors. The announcement of availability comes less than 2 weeks after Dexcom announced the availability of the Stelo and less than 3 months after Abbott announced the FDA clearance of the Rio and Lingo systems.

Later in the episode, hosts discuss how the 300-unit insulin reservoir with Embecta’s tubeless patch pump will offer a distinct advantage compared to other systems. In their release, Embecta called attention to a study finding a reservoir of this size would meet the needs of 64% of adults with type 2 diabetes for 3-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population.