medwireNews: The Omnipod 5 closed-loop, tubeless insulin delivery system has achieved good results in young children with type 1 diabetes over 12 months, with no cases of severe hypoglycemia or diabetic ketoacidosis recorded.
The results of the extension study were presented by Daniel DeSalvo (Baylor College of Medicine, Houston, Texas, USA) at the 82nd ADA Scientific Sessions in New Orleans, Louisiana. They follow on from successful 3-month results that were reported at the same conference in 2021.
The presenter highlighted that diabetes management in very young children can be particularly challenging. “These kids have unpredictable eating and activity patterns and high glucose variability, which makes them prone and susceptible to hypo- and hyper-glycemic excursions,” he explained.
“In fact, less than 2% of this age – 2 to less than 6 years – is meeting the glycemic target HbA1c [glycated hemoglobin] of less than 7.0% [53 mmol/mol],” he added, explaining that this has important clinical implications. For example, it could imply that these children are at risk for neurocognitive development problems with continued exposure to hyperglycemia.
The initial Omnipod 5 study recruited 80 young children (mean age 4.7 years) with type 1 diabetes and an HbA1c on screening of less than 10% (86 mmol/mol). The children followed their normal diabetes care for 14 days before switching to the Omnipod 5 tubeless automated insulin delivery system for 3 months.
The “pod” or insulin pump part of the Omnipod 5 system has an inbuilt algorithm and can communicate directly with the Dexcom G6 sensor, which is also part of the loop. The system can be viewed and controlled via a phone app and has customizable glucose targets of 110 to 150 mg/dL (6.1–8.3 mmol/L), so it can be adapted to each individual user.
Following good initial results at 3 months – for example, 54% achieved an HbA1c of below 7.0% vs 31% at the beginning of the study – the decision was made to extend the study for another 9 months to gain insight into how the system functioned over a longer period.
“Recent studies have shown some glycemic benefits short term with closed loop systems, but long-term data beyond 6 months have been lacking,” emphasized DeSalvo.
All 80 participants of the Omnipod 5 study continued with the extension. At 12 months, 49% of children enrolled in the study had achieved an HbA1c of less than 7.0%.
No cases of severe hypoglycemia were recorded in the study and at 12 months the children spent less than 2.0% of their time in mild hypoglycemia. There were also no cases of diabetic ketoacidosis recorded during the extension period.
Hyperglycemic improvements seen in the initial 3-month study were maintained. There were average reductions of 2.3 and 1.2 hours per day spent with blood glucose levels of at least 180 mg/dL or 250 mg/dL (10.0 mmol/L and 13.9 mmol/L), respectively.
Overall, 32% of the children achieved a dual target of less than 4% of time spent with blood glucose levels below 70 mg/dL (3.9 mmol/L) and more than 70% of time in the healthy blood glucose range of 70–180 mg/dL, as compared with 30% of the children at 3 months. By comparison, only 11% of the children met this target with standard therapy.
“These long-term data provide evidence of the durability of the Omnipod 5 for safely and effectively improving outcomes in very young kids with type 1 diabetes and also alleviating the burden of daily diabetes management,” concluded DeSalvo.
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