medwireNews: The Omnipod Horizon closed-loop system has delivered good glucose control in its first outpatient study, the investigators report.
Speaking at the virtual ADA 80th Scientific Sessions, Bruce Buckingham (Stanford University, California, USA) said that the Omnipod insulin pump is “a unique system in pumps on the market today,” being a non-tethered pump.
This means that the algorithm is on the pump itself, which communicates directly with the Dexcom glucose monitor without relying on a third device to remain in closed-loop mode. The presenter also noted that both elements are waterproof, and so are popular with athletes doing water-based sports. The pump is a disposable pod that is replaced rather than refilled.
There is also a phone app for set-up, changing glucose targets, and administering boluses.
During the run-in period, the 18 children (<14 years) and 18 adolescents and adults spent three 3-day periods using the system set at glucose targets of 130, 140, and 150 mg/dL (7.2, 7.8, and 8.3 mmol/L) followed by 5 days during which they could set their own targets.
The chosen glucose target was 110 mg/dL (6.1 mmol/L) for 52% and 59% of the time in adults and children, respectively, with higher targets used mostly for exercise and when children were unsupervised.
The primary endpoint was time in range (blood glucose 70–180 mg/dL, 3.9–10.0 mmol/mol) during the 3-month trial period, and this improved from 65.6% at baseline to 73.8% in the adults and from 51.0% to 70.1% in the children.
For the overnight period, the corresponding increases were 62.9% to 74.4% for adults and 55.6% to 80.9% for children.
Buckingham stressed how important these overnight data are for families, enabling them to sleep without worrying about hypoglycemia or being disturbed by alarms.
And he added: “For a number of kids, they got to go on their first sleepover during this study. They’d never been allowed [but] their parents felt very comfortable letting them go elsewhere.”
No participants experienced severe hypoglycemia or diabetic ketoacidosis, but there was one episode of prolonged hyperglycemia in an adult participant, caused by a dislodged cannula.
The system scored well with the study participants for usability, especially with caregivers and adolescents.
During discussion after the presentation, Chair Timothy Bailey (AMCR Institute, San Diego, California, USA) noted that the average System Usability Score (SUS) of 79 found among adults for the Horizon system for “most people doesn’t really mean anything, but it turns out that a typical iPhone has been shown to have a score of 79,” which is “pretty good, because most people regard iPhones as being usable.”
He said that system design will have an important role in the success of future devices and recommended that the SUS be included in all future trials of diabetes technologies.
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