Automated Insulin Delivery Effectively Lowers HbA1c in Type 2 Diabetes

Automated insulin delivery (AID) with Control-IQ+ technology led to a superior reduction in hemoglobin A1c (HbA1c) than continuous glucose monitoring (CGM) alone in adults with insulin-requiring type 2 diabetes (T2D).1

Conducted across 21 clinical centers in the U.S. and Canada, the 13-week trial randomly assigned 319 participants with insulin-requiring T2D in a 2:1 ratio to either the Control-IQ+ AID or their usual insulin-delivery method with a real-time CGM, representing a racially and socioeconomically diverse patient population.

“These results demonstrate the substantial value of Control-IQ+ technology for people with T2D who use insulin,” said Roy W. Beck, MD, PhD, medical director of the Jaeb Center for Health Research.2 “It was encouraging that even people using insulin plus a glucagon-like peptide 1 (GLP-1) receptor agonist drug, such as Ozempic, had substantial A1C improvement with the addition of Control-IQ+ to their treatment regimen.”

The benefits of AID technology for people with type 1 diabetes (T1D) are well established, but its efficacy and safety in individuals with T2D remain uncertain.3 While medications such as GLP-1 receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors help many with T2D to achieve HbA1c levels of ≤7%, those with persistently elevated levels may benefit from AID systems.4

The primary goal of the 13-week study was to assess changes in HbA1c after the Control-IQ+ system in adults with T2D, along with secondary measures such as CGM-measured time in range, time in hyperglycemia, time in hypoglycemia, and safety outcomes, including severe hypoglycemia and diabetic ketoacidosis.1

Among the 319 participants, 39% identified as a minority race or ethnicity, including 22% Black and 11% Hispanic. Additionally, 44% were on a stable dose of a GLP-1 receptor agonist, and 37% were taking an SGLT2 inhibitor, both of which were continued during the study. Before enrollment, 96% of participants used multiple daily insulin injections, with 75% receiving fixed-dose mealtime insulin.

The trial was completed by 211 of 215 patients (98%) in the AID group and 102 of 104 (98%) patients in the control group. Upon analysis at 13 weeks, the mean HbA1c levels decreased by 0.9% (8.2% to 7.3%) with AID and by 0.3% (8.1% to 7.7%) in the control group (mean adjusted difference, –0.6% [95% CI, –0.8 to –0.4]; P <.001).

For patients with high baseline HbA1c (≥9%), mean levels were reduced from 10.3% to 7.9% in the AID group and from 9.7% to 8.6% in the control group (mean difference, –1.0%; 95% CI, –1.5 to –0.5). Time in the target glucose range (70–180 mg/dL) increased from 48% to 64% in the AID group and from 51% to 52% in the control group (mean difference, 14% [95% CI, 11–17]; P <.001).

Beck and colleagues noted this difference represented a mean time in the target glucose range that was approximately 3.4 hours per day longer for the AID group than the control group. They found the treatment effects evident in the first week were sustained across the 3-month study period.2

Other multiplicity-controlled CGM outcomes reflective of hyperglycemia, including mean glucose, time >180 mg/dL, time >250 mg/dL, and the rate of prolonged hyperglycemic events, were all reduced in the AID group. CGM-measured hypoglycemia showed a low frequency at baseline and remained low during the study period.1

Further analysis revealed a reduction in total daily insulin dose in the AID group (–8 units/day), compared with the CGM group (+2 units/day). Investigators stressed there were no new safety signals unique to T2D users versus previous T1D studies—a single severe hypoglycemic event was identified in the AID group and resolved via oral carbohydrates.

“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,” said Jordan Pinsker, MD, chief medical officer of Tandem Diabetes Care.2

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. Published online March 19, 2025. doi:10.1056/NEJMoa2415948

2. Tandem Diabetes Care announces NEJM publication of positive pivotal study outcomes with control-IQ+ aid technology in type 2 diabetes. Tandem Diabetes Care. March 19, 2025. Accessed March 19, 2025. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-nejm-publication-positive-pivotal?_gl=1%2A1hc8pow%2A_gcl_au%2AMTA5MTAyNTMwNS4xNzQyMzAzNDM3

3. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019;381(18):1707-1717. doi:10.1056/NEJMoa1907863

4. American Diabetes Association Professional Practice Committee . 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025;48(Supplement_1):S181-S206. doi:10.2337/dc25-S009