How safe and effective is the first commercial configuration of a tubeless automated insulin delivery system, Omnipod 5, in children and adults with type 1 diabetes?
Diabetes technology continues to advance and transform to treat type 1 diabetes, yet the disease’s burden is still high. Omnipod® 5 is the world’s first tubeless, wearable automated insulin delivery system. A study was conducted to assess the safety and effectiveness of the Omnipod® 5 in children (6-13.9 years) and adults (14-70 years) who have type 1 diabetes (T1D).
“The Omnipod 5 System is phenomenal, improving diabetes outcomes for children and adults while greatly reducing the burden of diabetes management,” said Dr. G.P. Forlenza. “With the algorithm built into the Pod itself, it is easier than ever for people with diabetes to rely on automated insulin delivery to manage their blood glucose levels and keep them in range. Insulet has created an imposing device that will surely change lives.”
Users can operate the system using the Omnipod 5 mobile app, allowing them to select their basal profile, target bolus settings, glucose, and activate and deactivate the Pod. The Omnipod 5 operates in two modes, an automated mode and a manual mode. The system provides automatic insulin delivery with customizable glucose targets from 110 to 150mg/dl, and for personalization, it can be adjusted by time of day. The Pod can be worn for up to 3 days and is filled with a minimum of 85 U rapid-acting insulin and up to 200 U of U-100.
This single-arm, multicenter, prospective clinical study analyzed the safety and effectiveness of the Omnipod system in children and adults with T1D at three prespecified glucose targets (130,140, and 150 mg/dL), there was a period of choice of glucose targets between 110 and 150mg/dL. The participants spent 72 hours at each prespecified glucose target, and the remaining five days were a period of choice. There was a 14-day outpatient standard therapy phase, followed by a 14-day hybrid closed-loop (HCL) phase. This HCL system consists of a tubeless insulin pump and the Dexcom G6®. The participants who were not using the Dexcom G6 CGM for their diabetes care wore a blinded Dexcom G6 CGM while managing their diabetes at home. The participants who were already using the Dexcom G6 CGM at the study enrollment time provided their CGM glucose data from the most recent 14-day period.
At six sites in the United States, participants were recruited from December 2019 to January 2020. 36 participants were enrolled in this study; each of the six investigational sites had six participants. The individuals’ criteria were age 6-70 years, T1D for ≥six months, hemoglobin A1c (HbA1c) value <10%. The participants were divided into two groups after training on Omnipod 5 and transitioned to the phase. The first two days were supervised in a rental house or hotel before transitioning to an outpatient environment for 12 days.
To allow for real-time assessment of safety, the participants were monitored remotely. They were contacted for follow-up when the sensor glucose was <55, <70 mg/dL for 20 min or >300 mg/dL for one hour, or no data for 60 minutes. Adverse events such as hyperglycemia and hypoglycemic events were assessed and followed until resolved.
In comparison to the standard therapy phase, the participants experienced fewer episodes of hypoglycemia and hyperglycemia. The number of hyperglycemic attacks per day among adults was not significantly different between the two phases.
There was a significant decrease among children in the average number of total insulin units per day, per kg/day, and bolus insulin units per kg/day from the standard therapy (ST) to the HCL phase. On the other hand, the average number of basal insulin units per day and kg/day significantly decreased from the ST to the HCL phase among adults. The average number of user-initiated boluses per day increased from 5.8 ± 2.3 to 8.0 ± 2.2 among adults (P = 0.0002).
The small sample size and duration of the study are significant limitations. Following this HCL phase, the participants were able to transition into a pivotal 3-month survey. The analyses provided evidence that the Omnipod 5 System is safe and effective in patients aged 6–70 years with T1D at all target glucose levels, during the day and overnight.
- Omnipod 5 System has proven to be safe and effective in patients aged 6–70 with T1D.
- The size and duration of the study are limitations.
- Diabetes technology continues to advance and transform for the treatment of type 1 diabetes
Insulet corporation. Business wire. Insulet’s Omnipod® 5 Automated Insulin Delivery System Improves Clinical Outcomes in Type 1 Diabetes. News Release
Forlenza, G P et al. First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. Diabetes technology & therapeutics 2021
Brenda Oppong, PharmD Candidate, LECOM School of Pharmacy