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FDA Approves Tubeless Automated Insulin System for Kids 2 Years of Age and Older

By: Geraldine Ciaccio, PharmD Candidate c/o 2025

              Young children with type 1 diabetes (T1D) are completely dependent on others for their care and management. It can be hard for parents, guardians, teachers, and healthcare providers to assess a child’s condition as they are too young to properly communicate their thoughts and emotions. Most children are also reluctant and scared to receive injections, making it more difficult for parents and guardians to administer insulin. New therapies and devices aim to overcome these challenges and to ease the management of T1D for children and caregivers. 

On August 22, 2022, the Food and Drug Administration (FDA) approved the use of the Omnipod 5 automated insulin delivery system in children ages 2 years and older.1 Manufactured by Insulet Corporation, Omnipod 5 is the first tubeless automated insulin delivery system to be approved in the United States.2 Omnipod 5 is integrated with the Dexcom G6 Continuous Glucose Monitoring System, which continuously tracks glucose levels in real-time. Patients and caregivers can connect their smartphone to the device via the Omnipod 5 app where they can view real-time insulin levels and manage insulin dosing. The Omnipod 5, Dexcom G6, and the Omnipod 5 app are constantly communicating to deliver automatic insulin adjustments according to the patient’s customized target glucose level.3 Omnipod 5 was first cleared by the FDA for patients ages 6 years and older in January 2022, and further studies have supported its improved glycemic outcomes in very young children.1  

A recent clinical trial funded by Insulet Corporation showed improved glycemic outcomes in children ages 2 to 5 with T1D.3 From August 2020 to January 2021, the single-arm, multi-center, prospective study was performed at 10 different sites across the United States. The study included 80 children within this age range who were diagnosed with T1D and had a glycated hemoglobin, or hemoglobin A1c (HbA1c ), level of less than 10%. The parent, legal guardian, or caregiver of each of the participating children provided informed consent and agreed to operate the Ominpod 5, Dexcom G6, and app according to the provided training. The participants underwent a 14-day outpatient standard therapy phase with their usual treatment. Usual treatment for these participants included multiple daily insulin injections (MDI) or pump therapy. The purpose of the outpatient standard therapy phase was to collect participants’ baseline continuous glucose monitoring data. Following this first phase, a 13-week automated insulin delivery system phase was conducted. In this second phase, the Omnipod system was used to manage diabetes at home. The Omnipod system delivered insulin micro-boluses every 5 minutes using the participant’s customized glucose target value. After completing the 94-day hybrid closed-loop phase, subjects had the option to continue using the system for an additional 12 months.4 

The primary outcomes were decreased incidence rates of severe hypoglycemia and diabetic ketoacidosis. HbA1c levels and time within the range 70 to 180 mg/dL were compared to standard therapy data. During the second phase with the Omnipod system, there were no incidences of severe hypoglycemia or diabetic ketoacidosis. There were 20 instances of hyperglycemia, 12 of which were found to be related to the Omnipod device and infusion site issues.3 When using the automated insulin delivery system, HbA1c levels decreased as compared to standard therapy HbA1c levels. During the standard therapy phase, the mean HbA1c level was 7.4 ± 1.0%. During the automated insulin delivery phase, the mean HbA1c level was 6.9 ± 0.7%.3  

  Improved blood glucose levels were also seen in children using the Omnipod 5 as compared to standard therapy. Time in range values increased when compared to baseline and to consecutive previous days. The mean time within the range 70 to 180 mg/dL was measured to be 57.2 ± 15.3% in the standard therapy phase and 68.1 ± 9.0% in the automated insulin delivery phase.3 During days 1 to 3 of the automated insulin delivery phase, mean time in range was 61.3%. During days 4 to 6 of this phase, mean time in range was 67.8%.3 The time in range for participants increased each day of the trial, both overnight and throughout the day. With the use of Omnipod 5, children spent, on average, 2.6 more hours per day in targeted glucose level ranges, with 83% of participants achieving > 60% time within range.3 

The results of the trial demonstrated the safety and efficacy of Omnipod 5 in children ages 2 to 5. Improvements in glucose levels and management of T1D allow patients and caregivers to attain treatment goals with less of a burden. Proper management of a child’s diabetes is essential for preventing long-term complications. Insulet Senior Vice President and Medical Director, Trang Ly, MBBS, FRACP, PhD, praised the ability of Omnipod 5 to “further ease the burden of glucose management for these children and their caregivers.” 2 Patients can receive continuous insulin administration while using the automated insulin delivery system, reducing the number of injections and unhappy children with T1D. 


  1. Tedeschi V. FDA Clears Tubeless, Automated Insulin System for Kids Age 2 and Older. Medscape. Published 08/24/2022. 
  2. PT Staff. FDA Clears Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes Patients 2 Years of Age and Older. Pharmacy Times.  Published 08/22/2022 
  3. Ly T, Sherr J. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Journals. Published 07/26/2022.  
  4. Insulet Corporation. Omnipod Horizon™ Automated Glucose Control System Preschool Cohort. Published 04/23/2021.  
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