Insulet announced that its new Omnipod 5 automated insulin delivery system has improved glycaemic outcomes for young children with type 1 diabetes, in a 12-month study.

Omnipod 5 is a tubeless, wearable automated insulin delivery (AID) system, integrated with a continuous glucose monitor (CGM) to manage blood sugar.

It eliminates multiple daily injections, fingersticks, and can be fully controlled using a compatible personal smartphone, said the medical device maker.

In a three-month initial trial, Omnipod 5 was found safe and effective, significantly improved time in range and reduced HbA1c in 80 very young children with type 1 diabetes.

The system has significantly improved time in range and reduced HbA1c in children aged 2 to 5.9 years with Type-1 diabetes, in the 12 months extension phase.

Insulet senior vice president and medical director Trang Ly said: “One of our biggest goals in the development of Omnipod 5 was to ease the burden that type 1 diabetes places on families and caregivers of this vulnerable age group.

“With these preschool extension trial results, we have demonstrated improved glycemic results over the long term for very young children managing diabetes.”

Insulet said that the study results were analysed after all participants completed using Omnipod 5 for 12 months, including a three-month initial phase and nine months extension.

In the extension phase, the system significantly improved outcomes for participants, including reduced HbA1c and elevated time in range, with no episodes of DKA or severe hypoglycaemia.

The participants presented an average HbA1c of 6.9% after 12 months of Omnipod 5 use, compared with 7.4% at baseline, and 6.9% at the end of the three-month trial.

In addition, the use of Omnipod 5 for 10 to 12 months showed per cent time in the range of 67.6%, compared with 57.2% in standard therapy and 68.1% in the three-month trial.

In January this year, Insulet secured the US Food and Drug Administration (FDA) approval for its Omnipod 5 AID system in people with type 1 diabetes, aged six years and above.

Earlier this month, the medical device maker commenced the construction of its new manufacturing facility in Malaysia, to produce its Omnipod AID systems.