Tandem’s Automated Insulin Delivery Technology Shows Improved Outcomes in T2D
Control-IQ+ was associated with a greater reduction in glycated hemoglobin compared to a continuous glucose monitor alone.
The automated insulin delivery (AID) algorithm Control-IQ+ was associated with a greater reduction in glycated hemoglobin (A1C) compared to a continuous glucose monitor (CGM) alone in patients with type 2 diabetes (T2D), according to recent data published in The New England Journal of Medicine.1 The algorithm, manufactured by Tandem Diabetes Care, was initially approved for use in patients with type 1 diabetes (T1D) and was cleared by the FDA for T2D in February 2025.
Tandem’s Automated Insulin Delivery Technology Shows Improved Outcomes in T2D / Halfpoint - stock.adobe.com
The data comes from 2QIP (NCT05785832), a randomized controlled trial that evaluated the safety and efficacy of Control-IQ+ in adults with T2D who also used basal-bolus insulin therapy. Additional data from the study was presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes, held March 19 to 22 in Amsterdam, The Netherlands.
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“This study represents the most rigorous evaluation of automated insulin delivery technology for people with T2D ever conducted,” Roy W. Beck, MD, PhD, medical director of the Jaeb Center for Health Research, said in a release.2 “The randomized controlled design and broad inclusion goals that did not limit participation based on A1C levels allowed us to truly determine the treatment effect of the algorithm. These results demonstrate the substantial value of Control-IQ+ technology for people with type 2 diabetes who use insulin.”
2QIP included 319 patients, of which 39% identified as a minority race or ethnicity. Nearly half of the patients were taking a glucagon-like peptide-1 (GLP-1) receptor agonist and 37% were taking an SGLT-2 inhibitor and continued to throughout the study. Of the patients, 40% used more than 100 units of insulin per day and 75% were using a form of fixed dosing to calculate meal boluses. The patient data were collected from 21 clinical centers across the United States and Canada.
The primary study outcome was to compare change in A1C with Control-IQ+ technology versus a control group who continued a pre-study insulin regimen along with a real-time CGM system over 13 weeks. Secondary study outcomes included changes in time in range, time in hyperglycemia, time in hypoglycemia, and safety events.
The study found the mean A1C decreased by 0.9% in patients using Control-IQ+, compared to 0.3% for the CGM group. Time in range increased from 48% to 64% in the Control-IQ+ group, compared to 51% to 52% for the CGM group. In the Control-IQ+ group, insulin use decreased by 8 units per day, compared to an increase of 2 units per day in the CGM group. The benefits of the technology were seen across sex, race/ethnicity, body mass index, income, education, and prior experience with diabetes technology.
Additionally, device satisfaction and sleep quality as reported by patients was significantly improved with Control-IQ+. Use of the technology was seen to be safe, with a low frequency of hypoglycemia and no reports of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
“The benefits of Control-IQ+ technology were evident across an incredibly diverse population, regardless of pre-study glycemic control or experience with diabetes technology,” Jordan Pinsker, MD, chief medical officer at Tandem, said in a release.2 “These results underscore the potential of this technology to improve outcomes for people living with T2D who use insulin, while helping alleviate daily therapy burden and improve quality of life.”
READ MORE: Diabetes Resource Center
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References
1. Kudva YC, Raghinaru D, Lum Jw, et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025. doi:10.1056/NEJMoa2415948 https://www.nejm.org/doi/full/10.1056/NEJMoa2415948
2. Tandem Diabetes Care Announces NEJM Publication of Positive Pivotal Study Outcomes with Control-IQ+ AID Technology in Type 2 Diabetes. News Release. Tandem Diabetes Care. March 19, 2025. Accessed March 20, 2025. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-nejm-publication-positive-pivotal
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