Importance Patients with diabetes and food insecurity are at greater risk of adverse health outcomes. Effective strategies to promote healthy food access are urgently needed. Objective To evaluate the effect of a produce prescription (PRx) program on cardiometabolic health outcomes and health care utilization among patients with diabetes who were at risk of food insecurity. Design, Setting, and Participants This 2-arm, pragmatic, randomized clinical trial was conducted in an integrated academic health system in the southeastern US, and patients were recruited from June to August 2023 and followed up for 12 months. Patients were randomly assigned to be offered a PRx (treatment group) or continued to receive usual care (comparison group). Inclusion criteria included a diabetes diagnosis and being at risk for food insecurity. Randomization was stratified by mean hemoglobin A 1c (HbA 1c) level during the past year (≥8% vs lt;8%). Data were analyzed from October 2024 to April 2025. Intervention The PRx arm received a debit card loaded with 80 monthly for up to 12 months. The card was valid to purchase eligible fresh, frozen, or canned fruits, vegetables, and legumes from grocery retailers. Both arms received diabetes self-management educational materials. Main Outcomes and Measures Primary outcomes were HbA 1c levels and emergency department visits at 12 months following randomization. Secondary outcomes included body mass index, blood pressure, and inpatient visits. Results Of 9608 patients assessed for eligibility, 2155 provided consent and were randomized and studied. The mean (SD) age was 56 (14) years, 1524 (71%) were female, 112 (5. 3%) were Hispanic, 1272 (61%) were non-Hispanic Black, 663 (32%) were non-Hispanic White, and mean (SD) baseline HbA 1c levels were 7. 48% (1. 77%; to convert to the proportion of total hemoglobin, multiply by 0. 01). Benefit use was moderate, with only 433 participants (30%) using 80% or more per month. At 12 months, the treatment (n = 1450) and usual care comparison arm (n = 705) participants had an adjusted between-arm difference in HbA 1C levels of 0. 20 percentage points (95% CI, 0. 05%-0. 35%), favoring usual care. There were no significant between-group differences in emergency department visits, blood pressure, body mass index, and inpatient visits. Results were similar in the subgroup (n = 651) with elevated HbA 1c levels (≥8%). Conclusions and Relevance This randomized clinical trial found that the PRx program did not improve cardiometabolic health or health care utilization at 12 months. A produce prescription subsidy alone did not improve outcomes among patients with diabetes at risk for food insecurity. Trial Registration ClinicalTrials. gov Identifier: NCT05896644
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