The American Diabetes Association's 80th Scientific Sessions kicked off this weekend, and a handful of diabetes management device-makers and service providers highlighted new data as part of the virtual clinical conference. Read on for summaries of the studies and findings, as well as links to the online abstracts.
Verily-backed diabetes management service Onduo, which combines a mobile app, coaching, live consultations and connected-management devices, came to the show with two real-world analyses and a prospective study.
The first of these was a study of 612 Type 2 diabetes patients in the six months following their enrollment in the Onduo Virtual Diabetes Clinic. The researchers found a 0.4% decrease in HbA1C from baseline 7.7% among those not prescribed a continuous glucose monitor (CGM) (n = 399; p < .001), and a 0.9% decrease among those prescribed the device (n = 213; p < .001).
The second presentation, which was also shared in the ADA journal Clinical Diabetes, focused on a sample of 228 Type 2 patients who reported moderate or severe diabetes-related distress upon enrollment in Onduo's program. After six months, the participants reported an overall reduction in objective distress scores (p < .001), with additional reductions among subscale scores relating to regimen and emotional distress. Of note, stress reductions were greater among the 77 participants who prescribed and using the program's CGM device.
Finally, the prospective study recruited 55 adults with Type 2 diabetes from two primary care centers. After four months on the program, the participants demonstrated an overall HbA1c decrease of 1.6% (p < .001), with greater decreases observed among those with a baseline HbA1c over 9%. This study, however, also reported glycemic metrics collected by the CGMs prescribed to 43 participants. These showed a 10.2% increase in the time participants spent within their target blood glucose range (p = .002)
“Together, these data demonstrate how combining advanced technology with a personalized, relationship-based virtual care model can positively impact both health outcomes and quality of life,” Dr. Ronald Dixon, head of clinical affairs for Onduo, said in a statement. “The common thread through these findings is that CGM augments the effects of our program. Moving forward, we are exploring ways to more broadly and creatively integrate CGM into our program to promote better health for the most people possible.”
Among the slew of studies Medtronic brought to the virtual conference was a pivotal trial of its investigational MiniMed 780G Advanced Hybrid Closed Loop system.
Here, 39 adolescents and 118 adults with Type 1 diabetes used the system for two 45-day periods of differing blood glucose target set points. No serious adverse blood glucose episodes occurred during this period. Participants' overall time in range was 75%. They used the closed loop system's automated mode 95% percent of the time, with system-driven autocorrection contributing 22% of participants' daily bolus. A release from Medtronic also highlighted survey responses indicating a 96% user satisfaction rate, and fingerstick blood sugar system requests down 46% when comparing the MiniMed 780G to the company's MiniMed 670G system.
“The results of the study are exciting and are a welcome addition to what we have seen with other advancements in automated insulin delivery systems," Dr. Anders Carlson, medical director of the Park Nicollet International Diabetes Center in Minneapolis, and investigator of the study, said in a statement from Medtronic. “We often hear from our patients about wanting lower glucose target settings, and there is certainly a desire to see that represented more in the current marketplace. I’m pleased to see this next generation closed loop system continuing to improve in that direction.”
The company also highlighted a handful of poster studies for its extended-wear infusion set, which allows patients on insulin pump therapy to change their infusion sets less frequently than the two-to-three-day standard. These data suggest that the extended wear infusion set could be safe and effective for up to seven days.
Two sets of data backed by Abbott highlighted the company's FreeStyle Libre CGM and its role in reducing HbA1c and limiting hospitalizations.
The first was an observational retrospective study of Type 2 diabetes using the system alongside long-acting insulin or no insulin after six months (n = 774) and 12 months (n = 207). Researchers saw clinically significant drops in HbA1c across all groups and subgroups, with the greatest change occurring among the non-insulin group at six months (n = 497, 0.9% HbA1c reduction, p < .0001).
The other study used commercial claims and Medicare databases to review the outcomes of Type 2 diabetes patients who purchased a FreeStyle Libre between Q4 2017 and Q4 2018. Among 7,167 patients who met the participation criteria, the researchers found a reduction in acute diabetes events from 0.071 events per patient year to 0.052 events per patient year (hazard ratio 0.70, p < .001). Hospitalization fell from 0.180 events per patient year to 0.161 events per patient year (hazard ratio 0.87, p = .025).
"The real-world results are among the first studies that show use of the FreeStyle Libre system can deliver substantial reduction in HbA1c levels for those with type 2 diabetes, whether using insulin or not," Dr. Eden Miller, a family practice physician at High Lakes Health Care and one of the lead investigators of both studies, said in a statement provided by Abbott. "These data highlight how use of Abbott's continuous glucose monitor could be game-changing for people beyond intensive insulin users, translating to broader use of the technology to benefit all those living with diabetes, no matter where they are in the spectrum of care."
Insulin management software-maker Glytec arrived with a proof-of-concept, single-center prospective study applying its Glucommander product to the Freestyle Libre 14-day CGM.
Here, 25 adults with Type 2 diabetes and an HbA1c over 8% received the sensor and education on insulin management, meal planning and sensor use. During a four-week study period, patients improved their time in range from 48% to 74% by the final week of treatment (p <.00001).
“This study suggests there is a simplified approach to blood glucose management that provides immediate results and relieves the burden on patients and providers,” said John Clarke, R&D and clinical support at Glytec, said in a statement. “CGM removes the need for painful finger pricks and provides a vast amount of data for Glucommander to create personalized insulin doses. Without the need for provider intervention, patients experience better outcomes and quality of life while doctors can focus their time and resources on high priority cases.”