Automated insulin delivery provides range of glycemic benefits in type 2 diabetes
Key takeaways:
- Adults with type 2 diabetes using an automated insulin delivery system had greater HbA1c improvements vs. controls.
- The FDA cleared the use of the Control IQ+ system in adults with type 2 diabetes in February.
Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.
In the randomized controlled 2IQP trial, presented at the International Conference on Advanced Technologies & Treatments for Diabetes and simultaneously published in The New England Journal of Medicine, adults with type 2 diabetes using insulin were randomly assigned 2:1 to use the Tandem t:slim X2 insulin pump with Control IQ+ technology, or to continue their regular insulin delivery regimen for 13 weeks. Researchers found the Control IQ+ automated insulin delivery system conferred larger HbA1c reductions and improvements in multiple CGM metrics compared with a normal insulin regimen at 13 weeks. The benefits were also observed in adults using GLP-1s and SGLT2 inhibitors. Based on the results of the trial, the FDA cleared the Control IQ+ system for adults with type 2 diabetes in February.
Roy W. Beck, MD, PhD, president and medical director of the Jaeb Center for Health Research Foundation in Tampa, Florida and an author on the study, said while automated insulin delivery systems were originally developed for people with type 1 diabetes, the 2IQP trial revealed those with insulin-treated type 2 diabetes can also benefit from the technology.
“Although only a subset of people with type 2 diabetes require insulin, that number still exceeds the number with type 1 diabetes, all of whom use insulin,” Beck told Healio. “Thus, there was great value in demonstrating the benefits of automated insulin delivery for people with type 2 diabetes both for these individuals as well as from a public health perspective. Additionally, there are many people with type 2 diabetes who, despite insulin and drugs such as GLP-1s, still do not reach glucose targets and are at risk for diabetic complications. So, it was important to evaluate whether these people would benefit from automated insulin delivery.”
The researchers enrolled 319 adults aged 18 years or older with type 2 diabetes for at least 6 months prior to baseline who were receiving multiple daily insulin injections or using an insulin pump to participate in a 13-week trial in which they were randomly assigned to use automated insulin delivery or to a control group not using the system. Both groups used an unblinded Dexcom G6 continuous glucose monitor. The trial’s primary outcome was HbA1c level at 13 weeks. CGM metrics were assessed as key secondary outcomes.
There were 15 adults in the automated insulin delivery group who stopped using the system prior to the end of the trial but remained enrolled in the study. People using the automated insulin delivery system spent 93% of time in automated mode during the trial.
HbA1c changes
Mean HbA1c dropped from 8.2% at baseline to 7.3% at 13 weeks for adults using automated insulin delivery. The control group had a mean HbA1c decline from 8.1% at baseline to 7.7% at 13 weeks. The automated insulin delivery group had a greater reduction in HbA1c from baseline to 13 weeks than the control group (mean adjusted difference, –0.6 percentage points; 95% CI, –0.8 to –0.4). The percentage of adults with a more than 0.5 percentage point decrease in HbA1c from baseline to 13 weeks was 59% in the automated insulin delivery group vs. 30% in the placebo group.
Greater HbA1c reductions were observed for adults with a higher baseline HbA1c. Among adults with a baseline HbA1c of 9% or higher, those using automated insulin delivery had a mean HbA1c decline from 10.3% at baseline to 7.9% at 13 weeks vs. an HbA1c reduction from 9.7% at baseline to 8.6% at 13 weeks for the control group (mean difference, –1 percentage point; 95% CI, –1.5 to –0.5). Larger HbA1c reductions were also observed with automated insulin delivery among adults using GLP-1s, SGLT2 inhibitors or both classes of medication at baseline.
“The study results showed that automated insulin delivery provided substantial benefit for people with type 2 diabetes using insulin, and the benefit was greatest in those who had the highest HbA1c levels at baseline,” Beck said. “These are the people at greatest risk for diabetic complications, so it was rewarding to see that they experienced substantial benefit.”
Beck added that automated insulin delivery provided greater HbA1c reductions than a normal insulin regimen regardless of age, race and ethnicity and socioeconomic status.
CGM metrics
Adults using automated insulin delivery had an increase in time in range with glucose between 70 mg/dL and 180 mg/dL, from 48% at baseline to 64% at 13 weeks. The control group had a minimal change in time in range, from 51% at baseline to 52% at 13 weeks (mean difference, 14 percentage points; 95% CI, 11-17). The automated insulin delivery group also had a lower mean glucose, lower time above range with glucose more than 180 mg/dL or more than 250 mg/dL, and fewer prolonged hyperglycemia events than the control group. Time below range was similar between the two groups.
Safety data
Adverse events were reported by 30% of the automated insulin delivery group vs. 16% of the control group. Most of the events in the intervention group were not related to the automated insulin delivery system. There was one case of severe hypoglycemia with automated insulin delivery use, but the researchers noted the event was not due to a system error. There were 20 nonserious hyperglycemia events that were deemed device-related, with most tied to infusion set failures. No cases of diabetic ketoacidosis or hyperosmolar hyperglycemia syndrome were reported.
Looking ahead
The FDA’s clearance of the Control IQ+ in type 2 diabetes is the latest automated insulin delivery approval for adults with type 2 diabetes. As Healio previously reported, the FDA cleared the Omnipod 5 (Insulet) automated insulin delivery system in August 2024 after findings from the SECURE-T2D trial revealed the system led to large reductions in HbA1c at 13 weeks for adults with type 2 diabetes.
Unlike SECURE-T2D, which was a single-arm trial, Beck noted the 2IQP trial was the first randomized controlled trial to show glycemic benefits with an automated insulin delivery system among a large group of participants with type 2 diabetes.
Following the FDA’s clearance in February, Tandem Diabetes Care announced the launch of the Control IQ+ in the U.S. for people aged 2 years and older with type 1 diabetes as well as adults aged 18 years and older with type 2 diabetes. With the device now cleared in the U.S., Beck said longer-duration postmarketing studies of the system in people with type 2 diabetes can be conducted in the future.
References:
- Kudva YC, et al. N Engl J Med. 2025;doi:10.1056/NEJMoa2415948.
- Tandem Diabetes Care announces FDA clearance of Control-IQ+ automated insulin delivery technology for people with type 2 diabetes. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-control-iq. Published Feb. 25, 2025. Accessed March 19, 2025.
- Tandem Diabetes Care launches new Control-IQ+ automated insulin delivery technology in the United States. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-launches-new-control-iq-automated-insulin. Published March 18, 2025. Accessed March 19, 2025.
For more information:
Roy W. Beck, MD, PhD, can be reached at rbeck@jaeb.org.
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Kudva YC, et al. Parallel Industry Symposium 1. Presented at: International Conference on Advanced Technologies & Treatments for Diabetes; March 19-22, 2025; Amsterdam, Netherlands (hybrid meeting).