Sasson-Katchalski, Ravid

ABSTRACT Objective Automated insulin delivery (AID) has been established as an effective therapy for individuals with type 1 diabetes. This analysis evaluates the clinical and economic outcomes of AID compared with multiple daily injections plus continuous glucose monitoring (MDI/CGM) in adults with type 2 diabetes. Materials and Methods The IQVIA CORE Diabetes Model v10.0 was employed to simulate the impact of using the t:slim X2 insulin pump with Control‐IQ+ technology (Control‐IQ+) versus MDI/CGM over a 50‐year period using data from the 2IQP randomized controlled trial (NCT05785832). Trial data informed cohort demographics, intervention effects and resource utilization while literature sources provided health state utilities and costs. Scenario analyses examined the effect of Control‐IQ+ on reducing HbA1c based on alternative HbA1c progression estimates from the Swedish National Diabetes Registry and alternative resource use and treatment effects from real‐world evidence. Results The base case analysis indicated that direct medical costs per individual for type 2 diabetes management with Control‐IQ+ were $239 935 compared to $209 792 with MDI/CGM use. Control‐IQ+ resulted in 0.51 additional quality‐adjusted life years (QALYs: 10.36 vs. 9.85 for MDI/CGM), yielding an incremental cost‐effectiveness ratio (ICER) of $59 417 per QALY, 95% CI: ($55 836, $62 998). In probabilistic sensitivity analyses, 89% of simulations produced ICERs below $100 000/QALY. ICERs across all scenarios remained below $100 000 per QALY. Conclusions Control‐IQ+ is associated with increased life expectancy, higher QALYs and reduced complication rates. These findings suggest that Control‐IQ+ is cost‐effective relative to MDI/CGM for managing patients with type 2 diabetes in the United States.

OBJECTIVE The Centers for Medicare & Medicaid Services (CMS) requires a low C-peptide level for insulin pump coverage unless the individual is β-cell autoantibody positive, which precludes coverage of automated insulin delivery (AID) systems for many people with type 2 diabetes. RESEARCH DESIGN AND METHODS In the Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy study evaluating the t:slim X2 insulin pump with Control-IQ+ technology, adults with insulin-treated type 2 diabetes were categorized into high C-peptide (n = 195) and low C-peptide (n = 59) groups based on CMS criteria. RESULTS In the AID group, mean HbA1c decreased from baseline by 0.8%, which was significantly greater than in the control group with both high (P < 0.001) and low (P = 0.02) C-peptide levels. Results were similar in participants ≥65 years old. CONCLUSIONS The benefit of AID is present with high and low C-peptide levels. Thus, requiring a low C-peptide level as a prerequisite for AID therapy is not warranted.