Benefits of tubeless closed-loop insulin delivery system sustained at 1 year in young kids
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NEW ORLEANS — New data show sustained glycemic improvements and safety at 1 year in very young children with type 1 diabetes who used a tubeless hybrid closed-loop insulin delivery system, researchers reported.
Improved glycemic outcomes and safety in the initial 3-month pivotal study of the Omnipod 5 system (Insulet) in very young children persisted for an additional 9 months in an ongoing extension study, Daniel DeSalvo, MD, director of strategic collaboration at Texas Children’s Diabetes and Endocrine Care Center, said during a presentation at the American Diabetes Association Scientific Sessions.
“These long-term data provide evidence of the durability of the Omnipod 5 system in safely improving glycemic outcomes in very young children with type 1 diabetes,” DeSalvo said.
The study enrolled 80 children aged 2 to younger than 6 years with diagnosed type 1 diabetes at 10 U.S. centers. In the pivotal study, participants used the system for 3 months at home after 14 days of standard therapy, which included an insulin pump or multiple daily injections. They were then invited to participate in the extension study; all 80 children continued into the extension. Mean age was 4.7 years, with 20% aged 2 to 4 years; 43% were girls; baseline HbA1c was 7.4%; total daily insulin dose was 13.7 U; and 15% were multiple daily injection users at baseline.
“To date, some recent studies have shown some glycemic benefits short term with closed-loop systems, but long-term data beyond 6 months have been lacking,” DeSalvo said during the presentation.
Results showed an initial improvement in HbA1c at 3 months that was sustained through 1 year with continuous use of the Omnipod 5 system, representing an improvement from baseline of 0.52% (P < .05), DeSalvo said. Forty-nine percent of children achieved an HbA1c less than 7% after 1 year compared with 31% at baseline.
At 1 year, improvement in time in range (70-180 mg/dL) was maintained, with 2.5 hours more per day spent in the target range compared with baseline (P < .05). This was “not at the expense of having more hypoglycemia,” DeSalvo said. Less time was spent below range for these very young children; this was observed at 3 months and again sustained over the full year, with 3.5 minutes less per day below 70 mg/dL compared with baseline (P < .05), DeSalvo said.
No severe hyperglycemic events occurred during the longer-term follow-up. At 1 year, 2.3 hours less per day were spent above 180 mg/dL and 1.2 hours less spent above 250 mg/dL compared with baseline (P < .05).
Results also showed improved glycemic outcomes overnight, defined as midnight to 6 a.m., with 1.2 hours per night more spent in time in range, 1.1 hours per night less spent in hyperglycemia and 1.7 minutes per night less spent in hypoglycemia compared with baseline (P < .05).
At baseline, only 11% of children met both consensus targets for glycemic control (< 4% time below range and > 70% time in range). With Omnipod 5, the percentage that met both targets increased to 30% during the pivotal study and remained steady at 32% during months 10 to 12. When the researchers evaluated a less-stringent target time in range (> 60%), 29% of patients met both targets during standard therapy; this more than doubled to 65% during the pivotal study and remained steady during months 10 to 12, DeSalvo said.
No episodes of severe hypoglycemia or diabetic ketoacidosis occurred over 1 year.
“Sustained HbA1c reduction and improvement in time in range with minimal hypoglycemia supports the potential long-term benefit of the Omnipod 5 system. Glycemic control improvements may have clinical implications in optimizing neurocognitive development in young children with type 1 diabetes as suggested by the DirecNet study,” DeSalvo said during the presentation.
The Omnipod 5 system combines Insulet’s tubeless patch insulin pump with the Dexcom G6 continuous glucose monitoring system and a compatible smartphone with the Omnipod 5 mobile app to allow automatic insulin adjustments for people with type 1 diabetes.
This was one of the ADA President’s Select Abstract Presentations.
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DeSalvo D, et al. OR-33. Presented at: American Diabetes Association Scientific Sessions; June 3-7, 2022 (hybrid meeting).
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