Mobile closed-loop insulin system bests sensor-augmented pump in preventing hypoglycemia
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Patients with type 1 diabetes may be able to avoid hypoglycemia more effectively without an increase in hyperglycemic episodes if they use a mobile closed-loop control system instead of a sensor-augmented pump, according to findings published in Diabetes Care.
“Mobile closed-loop control can be an appealing alternative to artificial pancreas systems with control algorithms embedded in the insulin pump, offering certain potential benefits such as more elaborate user interface, portability across devices and improved user experience,” John Lum, MS, of the Jaeb Center for Health Research in Tampa, Florida, and colleagues wrote.
Lum and colleagues randomly assigned 13 weeks of use of either a mobile closed-loop control system that incorporated inControl AP software on a smartphone (n = 65; mean age, 33 years; 49% women) or a sensor-augmented pump (n = 62; mean age, 32 years; 45% women) to participants with type 1 diabetes. The researchers established baseline glucose levels using continuous glucose monitoring data from 2 weeks before the trial began and then compared how often in a 13-week span participants had glucose levels of less than 3.9 mmol/L or hypoglycemia and/or glucose levels of more than 10 mmol/L or hyperglycemia.
Across 13 weeks, participants who used the mobile closed-loop control system experienced hypoglycemia 2.4% of the time compared with 5% of the time at baseline. In contrast, across 13 weeks, participants who used the sensor-augmented pump experienced hypoglycemia 4% of the time compared with 4.7% of the time at baseline, equating to a 1.7% (95% CI, –2.4 to –1) adjusted mean difference between the two cohorts, demonstrating superiority of the mobile-closed loop control system, according to researchers.
Across 13 weeks, participants who used the mobile closed-loop control system experienced hyperglycemia 34% of the time compared with 40% of the time at baseline, whereas participants who used the sensor-augmented pump experienced hyperglycemia 39% of the time compared with 43% of the time at baseline, equating to a 3% adjusted mean difference (95% CI, –6.1 to 0.1) between the two cohorts. This indicated that the mobile-closed loop control system was not inferior, according to the researchers.
In addition, the researchers noted that when it came to factors such as time in range and the occurrence of hypoglycemia and hyperglycemia, the “benefits of the mobile closed-loop control system were particularly evident during nighttime.”
“This study achieved its predefined primary outcomes, showing the superiority of a mobile closed-loop system over sensor-augmented pump therapy in terms of reduced risk for hypoglycemia, accompanied by a noninferiority in terms of exposure to hyperglycemia,” the researchers wrote. “However, the form factor of the closed-loop system, mobile or embedded, may influence system reliability and usability. Our results suggest that mobile closed-loop systems are likely to be viable options in the future, provided that system connectivity can be reliably achieved.” – by Phil Neuffer
Disclosures: TypeZero Technologies, Dexcom, Riche Diabetes Care and Ascensia contributed equipment for this study. Lum reports he has received grant and other support from NIDDK, JDRF, the Helmsley Charitable Trust, Animas Corp., Bigfoot Biomedical, Eli Lilly and Tandem Diabetes Care. Please see the study for all other authors’ relevant financial disclosures.
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