ADA: Insulet sees gains in Type 1 diabetes study with tubeless insulin pump in young children

Over a 24-hour period, average blood glucose levels were significantly lower during treatment with the closed-loop Omnipod device, with patients spending 32% more time in range. (Insulet)

Insulet presented new data evaluating the use of its tubeless, closed-loop Omnipod insulin management system in young children with Type 1 diabetes.

Using an investigational version of the device, 14 children between the ages of two and six were supervised for over a week in a hotel to simulate the unique challenges of an at-home setting for this age group.

Following seven days of standard therapy with continuous glucose monitoring, the participants entered a two- to three-day treatment phase using the Omnipod’s personalized, predictive algorithms. During this second phase, meals were not restricted, and boluses were given according to the patient’s usual routine. Additionally, the participants exercised for more than 30 minutes per day.

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Over a 24-hour period, average blood glucose levels were significantly lower during treatment with the closed-loop Omnipod device, with patients spending 32% more time in range. Similarly low glucose levels were seen overnight, while the patients slept, with 47% more time spent in range.

RELATED: ADA 2018 - Closed-loop insulin delivery systems clear clinical tests

According to Insulet, the safety and performance of its Omnipod system was similar to that observed in older pediatric, adolescent and adult study participants. One severe hypoglycemic event was reported following exercise, which was treated with oral carbohydrates.

RELATED: Glooko makes its management app free to any person with diabetes

The results were presented at the annual Scientific Sessions of the American Diabetes Association in San Francisco alongside additional abstracts examining Insulet’s tubeless Omnipod device, including the real-world treatment patterns of thousands of adult and pediatric users as well as its use in combination with Glooko’s cloud-based diabetes data platform.

An observational study of more than 9,900 young pediatric and adolescent patients with Type 1 diabetes saw frequent bolusing with the Omnipod system and Glooko software, 5.3 times per day on average among users between the ages of 12 and 18. Between ages six and 11, that number increased to 6.4, and up to 7.5 among children under age six. Overall, the youth cohort data showed that blood glucose levels with a tubeless insulin pump compared favorably to those seen in larger Type 1 diabetes registries, the company said.

Similar results were seen in a separate analysis of about 8,000 adults with Type 1 diabetes with an average age of 40.8. There was an average of 4.7 bolus deliveries per day, with an average amount of 4.5 units of insulin each.

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