Automated insulin delivery system cuts HbA1c, boosts time in range in type 2 diabetes
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Key takeaways:
- Adults with type 2 diabetes had a 0.8 percentage point reduction in HbA1c at 13 weeks with the Omnipod 5.
- Fewer adults reported diabetes distress with the Omnipod 5 compared with baseline.
ORLANDO — A tubeless automated insulin delivery system improved multiple glycemic outcomes among a large group of adults with type 2 diabetes, according to data presented at the American Diabetes Association Scientific Sessions.
As Healio previously reported, the FDA cleared the Omnipod 5 (Insulet), the first tubeless automated insulin delivery system, for people aged 6 years and older with type 1 diabetes in January 2022. The clearance was later expanded to include children aged 2 years and older. In data from the SECURE-T2D trial, researchers found the system can also benefit adults with type 2 diabetes who require insulin.
“The use of Omnipod 5 was associated with significant improvement in HbA1c, time in range and reduction in the diabetes distress level,” Viral N. Shah, MD, professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at the Indiana University Center for Diabetes and Metabolic Diseases, told Healio. “This study provides an important message that automated insulin delivery like Omnipod 5 can improve glycemic outcomes in people with type 2 diabetes and also help in reducing burden and distress associated with managing diabetes.”
The SECURE-T2D trial enrolled 305 adults aged 18 to 75 years with type 2 diabetes who were using insulin for at least 3 months before enrollment and had an HbA1c between 7% and 12% for those who used only basal insulin or an HbA1c of less than 12% for all other insulin users (mean age, 57 years; 57% women). Baseline data were collected during 14 days of standard therapy. Participants used the Omnipod 5 system along with a Dexcom G6 continuous glucose monitor for 13 weeks. The primary outcome was change in HbA1c, with CGM metrics assessed as secondary outcomes. The type 2 diabetes distress assessment system (T2-DDAS) was used to measure diabetes distress. Participants with a score of 2 or higher were defined as having high diabetes distress.
The study group had an HbA1c reduction from 8.2% at baseline to 7.4% at 13 weeks. For adults who used only basal insulin before the study, HbA1c dropped from 8.6% at baseline to 7.5% with Omnipod 5. HbA1c reductions were greater among adults with higher baseline HbA1c values.
In subgroup analysis, Black adults had a decline in HbA1c from 8.6% at baseline to 7.8% at 13 weeks and Hispanic adults had an HbA1c decrease from 8.5% at baseline to 7.4% at 13 weeks. Both groups had a greater decline in HbA1c during the study than white adults.
“This is very important as we know that diabetes complications are higher among minorities,” Shah said. “The use of automated insulin delivery can reduce diabetes care disparities and may improve long-term outcomes.”
Time in range with a glucose level from 70 mg/dL to 180 mg/dL improved from 45% at baseline to 66% at 13 weeks. Time spent in hyperglycemia with a glucose level of more than 180 mg/dL declined from 54% at baseline to 34% at 13 weeks. No change was observed in time spent in hypoglycemia. There was one case of severe hypoglycemia unrelated to the device, and no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome reported in the study.
The proportion of adults with high diabetes distress declined from 66% at baseline to 55% at 13 weeks. At the end of the study, 90% of adults said they would recommend the Omnipod 5 to a family member or friend and 78% of participants wanted to continue using the system after the study.
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Pasquel FJ, et al. 1904-LB. Presented at: American Diabetes Association Scientific Sessions; June 21-24, 2024; Orlando.
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