This weekend saw the kickoff of the American Diabetes Association’s 78th annual conference, and with it a slew of new data from diabetes management players. The meeting included presentation on studies covering a range of technologies, such as continuous glucose monitors, insulin pumps, apps, and other digital-backed management strategies.
Among the studies highlighted by the association was an investigation of artificial pancreases capable of delivering co-formulations, as opposed to those that deliver insulin alone. While the system delivering the hormone amylin alongside insulin showed no improvement over a first-generation, rapid, insulin-only artificial pancreas, another that dosed amylin with rapid insulin kept 12 adults with Type 1 diabetes within a target blood glucose range 85 percent longer (versus 71 percent with the insulin-only artificial pancreas) and decreased glucose variability by 34 percent (versus 25 percent).
“We were expecting some benefits with the insulin-plus-pramlintide artificial pancreas, yet we were impressed by both the extent of improvements and the lack of side effects, considering these benefits were achieved without increasing the risk of dangerous low-glucose levels,” lead author Ahmad Haidar, assistant professor in the department of biomedical engineering, faculty of medicine at McGill University in Montreal, Canada, said in a statement. “This study shows that the first-generation, insulin-only artificial pancreas can be improved by delivering other hormones along with insulin, which will hopefully encourage the development of insulin-plus-pramlintide co-formulations.”
For pediatric patients, the association spotlighted the performance of Senseonics’ recently cleared implantable CGM system, the Eversense XL, in adolescents and adults over 180 days. According to the abstract, use of the CGM among 36 patients with Type 1 was both safe and accurate, with lead study author Dr. Ronnie Aronson, chief medical officer of LMC Diabetes & Endocrinology in Canada, noting in a statement that the team was “very pleased” with the CGM’s accuracy and long lifespan.
Also featured was data on Omnipod’s HorizonTM Automated Glucose Control System. These data, generated from 11 adults with Type 1 diabetes monitored over five days, compared the hybrid closed-loop system against an open-loop of standard therapy and CGM use at home, finding an 11.2 percent increase in target glucose range time. This difference increased to 13.2 percent overnight, according to the abstract, with similar improvements observed when measuring time spent in hypoglycemia.
“The Omnipod closed-loop system is an ‘untethered’ patch pump with no tubing, which is very attractive to some patients,” Dr. Bruce A. Buckingham, professor of pediatrics, endocrinology, and diabetes at Stanford University School of Medicine and the study’s chief investigator, said in a statement. “Previous studies showed that the Omnipod HCL algorithm was safe and performed well, and we were pleased to see that under free-living conditions it provides very good glucose control in a wide age range of subjects, especially overnight.”
While these three studies enjoyed a special nod from the ADA, a number of other diabetes management companies also attended the conference armed with new data on their tech-driven offerings.
Medtronic, for instance, showcased real-world data collected from 32,178 users of its MiniMed 670G system that suggest a 73.1 percent time in range increase resulting from use of the company’s algorithm-driven system. When compared to data collected in a previous investigation of multiple-daily injection (MDI) patients, this rate translated to a 41.1 percent increase over MDI, as well as a 41.2 percent and 44.2 percent reduction of time in hypoglycemic range and hyperglycemic range, respectively.
"These data are compelling and demonstrate that MDI patients are doing very well on the MiniMed 670G system and are experiencing significant time in range improvements," Dr. Anders Carlson, medical director at the International Diabetes Center, said in a statement from the company. “In addition to the clinical benefits, reducing mental burden associated with diabetes management is a key component to improving their overall wellness and this innovative system is a major step towards that goal."
Abbott came to the table with a handful of late-breaking abstracts regarding its FreeStyle Libre CGM system. From these came a number of studies regarding the system’s impact, among which was a meta-analysis of 17 different studies that indicated a –0.56 percent change in HbA1c. Two more investigations showed a decrease in glucose variability among 237,747 individuals using the device, and a significant decrease of time in hypoglycemia among data collected through 237,747 receivers. Other data suggested a cost savings of more than $120 per month when compared to the purchasing cost of six daily test strips, and increased glycemic control among teenagers and young adults.
"These new data provide clear proof that the FreeStyle Libre system empowers people with diabetes to take control of their lives, make informed health decisions and live life fully without the burden of fingersticks," Jared Watkin, senior vice president of diabetes care at Abbott, said in a statement.
The costs of diabetes management was also the subject of a poster study sponsored by Livongo Health. Here, 2,2027 diabetes patients participating in the Livongo program saved an estimated $83 monthly when compared to a cohort of 8,385 non-users. The savings were primarily driven by decreased spending on outpatient visits, according to the study that also found a link between decreased monthly spending and improved blood glucose control. The company also presented the results of a second observational study based on real-world data from tens of thousands of patients who had used the company’s connected meters for more than 12 months.
“Diabetes is a chronic condition that cannot be reversed but can be managed over time. These new findings demonstrate improved health and reduced costs over 12 months for people with diabetes,” Dr. Jennifer Schneider, chief medical officer for Livongo and an author on both studies, said in a statement.
Another study, sponsored by Ascensia Diabetes Care and broken into three separate poster presentations, investigated user experiences with the company’s Contour Next One smart meter and app system over a six-week period. The results indicated that most patients felt the system increased their understanding of diabetes (98 percent), helped them feel more engaged with their management program (91 percent), and said that they felt more motivated to adherence to recommended therapy and testing (76 percent). In addition, researchers found over the course of the study a significant decrease in fructosamine levels — but not in HbA1c levels — as well as a decrease in the number of high blood glucose measurements.
From DarioHealth, additional trio of posters described changes in patients’ conditions when using the company’s digital diabetes management system. In one, an analysis of 17,156 Type 2 diabetes patients using the system, researchers noted a 19 percent reduction in the average ratio of high glucose events and an 11 percent increase in the ratio of normal range readings. Another study of 225 users observed over the course of a year found a 20 percent reduction and 58 percent reduction in high and severe hyperglycemic events, respectively. The third study described continuous reduction in glucose level averages among 238 “highly engaged” users with high initial blood glucose levels, among whom more than three-quarters reduced their average blood glucose level over the course of a year.
“Data presented in these posters offer evidence that a new paradigm of treatment, which leverages digital technology, empowers people living with diabetes, and creates improved outcomes,” Erez Raphael, chairman and CEO of DarioHealth, said in a statement.
Novo Nordisk brought an investigation of its Cornerstones4Care Powered by Glooko app to the conference. Here, researchers used data from 112 patients with Type 1 diabetes recording their blood sugar levels on the platform over a 14-day period, to identify a relationship between blood sugar variability and the amount of time an individual will experience low blood sugar. The findings underscore the value of looking beyond HbA1c levels to understand a patient’s condition and highlight the utility of CGM data for clinical study, the researchers wrote.
Hygieia’s cloud-based d-Nav Insulin Guidance Service was also the subject of a study presented at the conference. According to a release, the researchers enrolled 181 patients with Type 2 diabetes in a one-to-one investigation comparing the automatic insulin titration strategy against standard care. Along with increased average HbA1c reduction, they found high levels of satisfaction, comfort, and retention among patients prescribed the system, all accompanied by an increase in their average daily dose of insulin.
“Insulin under-treatment can lead to serious health complications,” Dr. Israel Hodish, associate professor of internal medicine at the University of Michigan and Hygieia cofounder, said in a statement. “The data presented today underscore the potential for substantially better insulin management through validated technologies such as the d-Nav Service, which could lead to significant reductions in diabetes complications and costs of care.”