medwireNews: The Omnipod 5 tubeless automated insulin delivery system improves glycemic outcomes of very young children with type 1 diabetes and the sleep of their caregivers, report researchers.
The system consists of a tubeless insulin-filled pod containing the control algorithm, a Dexcom G6 continuous glucose monitor, and an Omnipod 5 app used to adjust settings, deliver boluses, etc.
Results for the system in adults and children aged 6 years or older have previously been reported. Jennifer Sherr (Yale School of Medicine, New Haven, Connecticut, USA) presented the findings in younger children at the virtual ADA 81st Scientific Sessions.
She said: “As a pediatric endocrinologist, I can attest to the difficulty of managing this age group, due to grazing eating patterns, erratic physical activity, and oftentimes care providers may fear hypoglycemia, as these youths cannot verbalize or self-treat lows.”
The 80 children involved in the study were aged between 2.0 and 5.9 years, with 20% being between 2 and 4 years. Their baseline glycated hemoglobin (HbA1c) levels ranged from 5.4% to 10.2% (36 to 88 mmol/mol), and 15% were using multiple daily insulin injections, rather than an insulin pump.
The Omnipod 5 system has customizable glucose targets from 110 to 150 mg/dL (6.1–8.3 mmol/L), which can be varied according to the time of day. The most used target was 120 mg/dL (6.7 mmol/L), which was used for 42% of cumulative study time, followed by the 110 mg/dL target, accounting for 33% of the time.
The study consisted of a 2-week phase of standard treatment followed by 3 months using the closed-loop system and an optional 12-month extended use phase. All participants completed the study and continued into the optional phase.
During 3 months of Omnipod 5 use, the children’s average HbA1c level fell from 7.4% to 6.9% (57 to 52 mmol/mol), and Sherr noted that the proportion of children achieving HbA1c below 7.0% (53 mmol/mol) increased from 31% to 54%. The largest improvements occurred in children with the highest baseline HbA1c; in those with a starting level of 8% (64 mmol/mol) or higher HbA1c fell by an average of 1.06 percentage points, compared with 0.31 percentage points in those with lower baseline HbA1c levels.
Time in range (blood glucose 70–180 mg/dL; 3.9–10.0 mmol/L) rose from an average 57.2% to 68.1%, representing an additional 2.6 hours within range per day. This was driven largely by reductions in time in hyperglycemia, with average 2.4 and 1.3-hour reductions in time spent above 180 and 250 mmol/L, respectively.
The largest improvements were seen for overnight hyperglycemia, although improvements were noted throughout the day, and were associated with significantly improved sleep quality for parents and caregivers.
Time below range was very low at baseline, but there was still a significant median reduction of 4 minutes/day spent below the 70 mg/dL threshold. There were no instances of severe hypoglycemia or diabetic ketoacidosis during the study.
In response to a query about when the system will become available, Sherr said that it is currently being reviewed by the FDA.
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