Editors: David L. Joffe, BSPharm, CDE, FACA
How safe and effective is that 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 change to treat type 1 diabetes, but the burden of disease is still high. Omnipod® 5 is the world’s first tubeless, portable, automated insulin delivery system. A study was done to determine the safety and effectiveness of the Omnipod® 5 in children (6-13.9 years) and adults (14-70 years) with type 1 diabetes (T1D).
“The Omnipod 5 system is phenomenal, improving diabetes outcomes for children and adults while reducing the burden of diabetes management, “said Dr. GP Forlenza. “With the algorithm built into the pod itself, it is easier than ever for diabetics to rely on automated insulin delivery to monitor and control their blood sugar levels. Isolate has created an imposing device that will surely change lives. ”
Users can access the system through the Omnipod 5 mobile app with which you can select your basal profile, target bolus settings, glucose and activate and deactivate the pod. The Omnipod 5 works in two modes, one automated mode and a manual mode. The system offers automatic insulin delivery with adjustable glucose target values from 110 to 150 mg / dl and can be adjusted for personalization according to the time of day. T.he Pod can be worn for up to 3 days and is filled with at least 85 U of fast-acting insulin and up to 200 U U-100.
This one-armed, multicenter, prospective clinical study analyzed the safety and effectiveness of the Omnipod In children and adults with T1D at three predefined glucose target values (130, 140 and 150 mg / dL), there was a period of choice for glucose target values between 110 and 150 mg / dL. Participants spent 72 hours at each given glucose goal and the remaining five days wLikewise a period of choice. This was followed by a 14-day standard outpatient therapy phase, followed by a 14-day hybrid closed loop phase (HCL). This HCL system consists of a tubeless insulin pump and the Dexcom G6®. Participants who did not use the Dexcom G6 CGM for their diabetes care wore a blinded Dexcom G6 CGM while treating their diabetes at home. Participants who were already using the Dexcom G6 CGM when enrolled in the study reported their CGM glucose data from the previous 14-day period.
Participants were recruited from December 2019 to January 2020 at six locations in the USA. 36 participants were included in this study; each of the six test centers had six participants. The criteria of the persons were age 6-70 years, T1D forsix Months, hemoglobin A1c (HbA1c) value <10%. The participants were divided into two groups after the training Omnipod 5 and went into phase. The first two days were cared for in a rental house or hotel before moving to an outpatient environment for 12 days.
Participants were remotely monitored to enable real-time safety assessments. You were contacted for follow-up when the sensor glucose was <55, <70 mg/dL for 20 min or >300 mg / dl for an hour or 60 minutes no data. Adverse events such as hyperglycemia and hypoglycemic events were scored and followed until resolved.
Compared to the standard therapy phase, the participants experienced fewer hypoglycaemia and hyperglycaemia episodes. The number of hyperglycemic attacks per day in adults did not differ significantly between the two phases.
There was a significant decrease in the average number of total insulin units per day per kg / day and bolus insulin units per kg / day in children from standard therapy (ST) to the HCL phase. On the other hand, the average number of basal insulin units per day and kg / day in adults decreased significantly from the ST to the HCL phase. The average number of user-triggered boluses per day in adults increased from 5.8 ± 2.3 to 8.0 ± 2.2 (P.= 0.0002).
The small sample size and the duration of the study are major limitations. After this HCL phase, the participants were able to move on to a 3-month survey relevant to approval. The analyzes provided evidence that the Omnipod 5 The system is safe and effective in patients 6–70 years of age with T1D at all daytime and nighttime glucose target values.
- Omnipod 5 The system has been shown to be safe and effective in patients 6–70 years of age with T1D.
- The scope and duration of the study are limited.
- Diabetes technology continues to advance and change for the treatment of Type 1 diabetes
Isolate Group. Business wire. Insulet’s Omnipod®5 Automated insulin delivery system improves clinical outcomes in type 1 diabetes. Press release
Forlenza, GP et al. First outpatient evaluation of a tubeless automated insulin delivery system with adjustable glucose targets in children and adults with type 1 Diabetes. Diabetes Technology & Therapeutics 2021
Brenda Oppong, PharmD Candidate, LECOM School of Pharmacy