Adults with type 2 diabetes see glycemic benefits with automated insulin delivery
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Key takeaways:
- In a small feasibility study, adults with type 2 diabetes had HbA1c reductions with use of the Omnipod 5.
- Improvements in time in range and a decrease in total daily insulin dose were observed.
Using a pod-based automated insulin delivery system can provide glycemic benefits for people with type 2 diabetes, according to a speaker at the International Conference on Advanced Technologies & Treatments for Diabetes.
As Healio previously reported, the FDA cleared the Omnipod 5 system (Insulet) in January 2022 for people with type 1 diabetes aged 6 years and older. The system, which combines Insulet’s tubeless patch insulin pump with the Dexcom G6 continuous glucose monitor, is not approved for use among people with type 2 diabetes. However, Anne L. Peters, MD, a Healio | Endocrine Today Editorial Board Member, diabetologist and professor of clinical medicine at the Keck School of Medicine of the University of Southern California, discussed results from a small study published in Diabetes Care in 2023 that showed adults with type 2 diabetes also can reduce their HbA1c and improve time in range with the Omnipod 5 system.
“From my own practice [experience], there’s so many reasons that automated insulin delivery, particularly delivered through a pod, is helpful in my patients with type 2 diabetes,” Peters said during a presentation.
Automated delivery reduces HbA1c
Peters and colleagues conducted a small feasibility study at four institutions in the U.S. The study enrolled 24 adults aged 18 to 75 years with type 2 diabetes and a baseline HbA1c of 8% to 12%. Participants who used insulin injections did not use an insulin pump within 3 months of screening at baseline were eligible. After a 14-day standard therapy phase where adults wore a CGM, participants began using the Omnipod 5 automated insulin delivery system for 8 weeks. There were no restrictions on diet or physical activity during the study, and participants continued to use previous anti-hyperglycemic medications.
The study group included 12 adults who had multiple daily injection therapy at baseline and 12 adults who were receiving only basal insulin injections. Of the study group, 54% were using a CGM for the first time and 96% were using an insulin pump for the first time.
Among adults who had used multiple daily injections, HbA1c declined from 9.4% at baseline to 8.1% at 8 weeks (P = .0001). Time in range with a glucose level of 70 mg/dL to 180 mg/dL improved from 42.8% at baseline to 60.5% at 8 weeks (P = .0019), and time below range with a glucose level of less than 70 mg/dL dropped from 0.31% at baseline to 0.1% at 8 weeks (P = .021).
The basal insulin group similarly had a decline in HbA1c from 9.5% at baseline to 8.1% at 8 weeks (P < .0001) and an improvement in time in range from 30.5% at baseline to 56.6% at 8 weeks (P < .0001). No change in hypoglycemia was observed for the basal insulin group.
No changes in BMI were observed for either group. The multiple daily injection group had a decline in total daily insulin dose from 92.4 U per day at baseline to 63.1 U per day at 8 weeks (P = .003). No change in total daily dose was seen for the basal insulin group.
After the 8-week study, participants were invited to continue using Omnipod 5 in a 6-month extension. During the extension phase, the multiple daily injection group had a further decline in HbA1c to 8%, and adults who used basal insulin at baseline had an HbA1c reduction to 7.5%.
More studies to come
Research on Omnipod 5 use for adults with type 2 diabetes is continuing with the SECURE-T2D clinical trial. The study, which began in April 2023 and is scheduled to be completed in 2024, enrolled 305 adults aged 18 to 75 years with type 2 diabetes and an HbA1c of less than 12% for basal and bolus insulin or pre-mix insulin users, or an HbA1c of 7% to less than 12% for adults using basal insulin only. After 2 weeks of standard therapy, participants used the Omnipod 5 system for 13 weeks. Change in HbA1c will be study’s primary endpoint. The study will also assess safety endpoints of severe hypoglycemia, hospitalization and ED visits for severe hypoglycemia, hyperosmolar hyperglycemic syndrome and diabetic ketoacidosis cases, other serious adverse events and device-related adverse events.
The biggest limitation with the Omnipod 5, according to Peters, is the need for the user to have a smartphone that is compatible with the system’s app, which can be an issue for under-resourced patients. However, she said the device and other automated insulin delivery systems can be a benefit for adults with type 2 diabetes.
“These systems have a lot of potential for people with type 2 diabetes from any socioeconomic status, and it’s been helpful in my patient population,” Peters said.
Reference:
Davis GM, et al. Diabetes Care. 2023;doi:10.2337/dc22-1915.
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Peters A. Pod use for closed-loop in type 2 diabetes. Presented at: International Conference on Advanced Technologies & Treatments for Diabetes; March 6-9, 2024; Florence, Italy (hybrid meeting).
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