New Meds and Tech from PES Drugs and Therapeutics committee

The Omnipod 5 (Insulet Inc) is a hybrid closed-loop system approved by the FDA on January 28, 2022 for use in children ≥ 6 years and adults with type 1 diabetes mellitus and subsequently approved in children as young as 2 years. Approval was based on a single-arm, multicenter, prospective study of three months of Omnipod 5 use in 240 children and adults [1]. It is the latest addition to the other FDA-approved closed loop systems in the US including Control-IQ for the t:slim X2 insulin pump by Tandem Diabetes Care and Medtronic’s MiniMedTM 770G. Omnipod 5 is an automated insulin delivery (AID) system comprised of a tubeless pod that communicates with the Dexcom G6 continuous glucose monitoring system (CGM) using Bluetooth technology to make automatic adjustments to the basal insulin rate every 5 minutes based on current and projected glucose values, insulin on board, and the user’s insulin sensitivity factor. The system can be operated by the Omnipod Controller or the Omnipod 5 app on compatible smartphones (see omnipod.com/compatibility for an up-to-date list of compatible smart phones). Omnipod 5 will be available through pharmacies and is not covered as durable medical equipment (DME). Omnipod 5 pods are similar in appearance to the DASH pods but are not compatible with prior Omnipod systems. Pods are waterproof and are approved for continuous use up to 72 hours.

Other new features:

  • Glucose targets can be adjusted by the time of day and activity from 110 to 150 mg/dL (in 10 mg/dL increments)
  • Adaptive basal rate adjusts with each subsequent Pod change based on previous usage (total daily insulin) and glucose target
  • A bolus calculator that uses the CGM value and trend to adjust the suggested bolus dose
  • Activity mode reduces insulin delivery and temporarily sets the target glucose to 150 mg/dL

Reference:

  1. Brown SA et al., for the OmniPod 5 Research Group. Multicenter trial of a tubeless on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Diabetes Care. 2021:44:1630-1640

Prepared on behalf of PES Drugs and Therapeutics Committee by: Christine Yu, MD, and Amit Lahoti, MBBS, FAAP

Last updated: August 31, 2022

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