Companies like Dexcom and Insulet have been working to expand the reach of their devices from Type 1 diabetes into Type 2, which would include millions of people in the U.S. These technologies have already made great strides in easing the daily burden of managing Type 1—by calculating insulin delivery and adjusting for changes in blood sugar levels—but expanding their reach into Type 2 would cover more than 90% of the nearly 40 million people in the U.S. living with diabetes. “By leveraging these innovations, we can empower patients with more effective and manageable treatment options, ultimately transforming the landscape of diabetes care,” Robert Gabbay, chief scientific and medical officer of the ADA, said in a statement during the association’s annual meeting in Orlando. First, a real-world analysis showed that the addition of CGM alone could help many patients keep their glucose more within a healthy range—including among three groups of people: those taking background or bolus insulins, and those using non-insulin therapies. The analysis of more than 7 million healthcare claims focused on about 6,000 people; each group saw their HbA1c levels improve by at least 1 percentage point within the year following their first CGM, after starting with an average baseline of 8.8%.
The same database also showed that the rate of both all-cause hospitalizations and acute diabetes-related hospitalizations were cut by more than half. “These results suggest that CGM can play a crucial role in enhancing health outcomes for all diabetes patients, regardless of their treatment regimen,” said the study’s lead author, Satish Garg, of the University of Colorado. “The real-world analysis underscores the potential of CGM to not only improve glycemic outcomes but also reduce healthcare resource utilization and overall healthcare costs.” Meanwhile, the wearable, tubeless insulin pump maker Insulet presented data from its Omnipod 5 system, showing that it could increase the amount of time spent in a healthy blood sugar range by 20%—while also lowering a person’s total daily dose of insulin by an average of about 23 units per day. The SECURE-T2D pivotal trial tracked a diverse group of over 300 adults with Type 2 diabetes who had been taking insulin for at least three months. After using the Omnipod 5 for 13 weeks, average HbA1c levels dropped from 8.2% to 7.4%. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race,” said Insulet’s medical director, Trang Ly. “These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.” According to the company, the trial was the largest and most racially diverse to study automated insulin delivery systems among people with type 2 diabetes, including 24% Black and 22% Hispanic participants. In addition, 55% were on a stable regimen of GLP-1 medications. Currently, the Omnipod 5 is cleared in the U.S. for adults and children with Type 1 diabetes, and the company recently fully rolled out the system to the U.K. and the Netherlands. Insulet said it has already submitted the SECURE-T2D study data to the FDA in a bid to expand its use to people with Type 2 diabetes, with an eye on potential commercial launch early next year. Currently, there are no FDA-cleared automated insulin delivery systems for Type 2 diabetes. At the same time, a real-world study of Dexcom’s G6 and G7 wearable CGM sensors showed significant gains following six months of use—tracking more than 3,800 adults who were not taking insulin and had initially not been meeting their blood sugar targets. That included a 0.5 percentage point reduction in CGM approximations of A1c, and an additional four hours each day within a healthier glucose range. The study also showed that users who received automated hyperglycemia alerts saw the greatest improvements. Dexcom also presented a separate study showing its CGM could help guide behavior changes among people with prediabetes—including improvements in self-care related to eating, physical activity, weight and blood pressure, as well as in reported measurements of anxiety, energy levels and healthcare provider interactions. Also during the ADA meeting, Dexcom also announced that its G7 CGM sensor would now be compatible with Insulet’s Omnipod 5 tubeless pump. “As the evidence of the benefits of CGM use by people with Type 2 diabetes and prediabetes continues to grow, Dexcom is uniquely positioned to address their needs through our portfolio of products,” said Dexcom’s chief operating officer, Jake Leach, who also cited the company’s upcoming launch of its Stelo over-the-counter CGM set for this August. Stelo was cleared by the FDA this past March, allowing adults 18 years and older that are not taking any insulin therapies to purchase the system without a prescription—a population the company estimates includes about 25 million people with Type 2 diabetes. Dexcom has pitched the Stelo as a slimmed-down, “health-focused” version of its top-of-the-line G7, without the low blood sugar alerts or software features needed by people who use real-time blood sugar readings to calculate insulin doses.