Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes
Largest, longest, and most racially diverse study of automated insulin delivery (AID) conducted in people with type 2 diabetes to date
The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.
“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly MBBS, FRACP, PhD,
Even though over 30 million people live with type 2 diabetes in
“Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery,” said Dr.
Study Overview
The primary objective of the SECURE-T2D Pivotal Trial was to evaluate change in HbA1c with Omnipod 5 in adults aged 18-75 years, living with type 2 diabetes with a current insulin regimen for at least three months. Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin. Secondary objectives included demonstrating improvements in time in range, and time in hyperglycemia, as well as demonstrating non-inferiority for hypoglycemia. Additionally assessed as a secondary objective was diabetes distress, a patient-reported outcome.
As one of the most racially diverse studies in diabetes technology, the data represented 305 participants from 21 sites across the
Key Data Highlights
-
Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from 8.2% to 7.4%, or a reduction of 0.8%.
- Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was 2.1% for those with a baseline HbA1c ≥9.0%.
-
Significant improvements for HbA1c were observed regardless of prior therapy at the start of the trial, including:
- Multiple daily injections and in those transitioning from basal-only insulin therapy
- GLP-1 users and non-GLP-1 users, suggesting that adults with type 2 diabetes who require insulin therapy can greatly benefit from AID regardless of whether they are already using other glucose-lowering medication
- Current users or non-users of continuous glucose monitoring (CGM), suggesting an added benefit of AID in type 2 diabetes beyond the glycemic benefit observed with CGM use
- Time in range significantly improved with Omnipod 5, increasing by 20%, or 4.8 hours/day, from 45% to 66%. This finding was driven by reductions in hyperglycemia levels including time above 180, 250 and 300 mg/dL.
- Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improving glycemic control with Omnipod 5 did not increase hypoglycemia risk.
- Additional outcomes analysis showed that the amount of insulin used was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day.
- As reported by patients through individual surveys (T2-DDAS), there was a significant and clinically meaningful improvement in diabetes distress: the percentage of participants with high diabetes distress (T2-DDAS total score ≥2.0) was significantly reduced.
- There were no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). There was one occurrence of severe hypoglycemia during the treatment phase, deemed unrelated to trial device malfunction. There were 13 additional serious adverse events, but none were glycemia-related nor related to the trial device.
The SECURE-T2D pivotal trial data will be discussed in several events at
Poster Presentation: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr.
ePoster Theater: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr.
Analysis of GLP-1 and Insulin Use in Type 2 Diabetes
Separately,
1National Diabetes Statistics Report: https://www.cdc.gov/diabetes/php/data-research/
About
Forward-Looking Statement:
This press release may contain forward-looking statements concerning
©2024
View source version on businesswire.com: https://www.businesswire.com/news/home/20240621869326/en/
Investor Relations:
Vice President, Investor Relations
(978) 600-7717
dgordon@insulet.com
Media:
Senior Director, Corporate Communications
(978) 932-0611
awiczek@insulet.com
Source: