What is the clinical evidence from this study?

Study design: RCT. Population: Type 2 diabetes and food insecurity (n=194). Intervention: Medically tailored meals (MTM) and telephone lifestyle intervention vs. Food subsidy ($40/month for healthy groceries). Primary outcome: Hemoglobin A1c (HbA1c) (MD -0.42%, 95% CI -0.82 to -0.03, p=0.037).

What does this research mean for the field?

For adults with type 2 diabetes and food insecurity, medically tailored meals combined with a lifestyle intervention significantly lower HbA1c and systolic blood pressure compared to a standard food subsidy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This trial aimed to compare the effects of medically tailored meals and food subsidies on diabetes outcomes.

June 9, 2026

1249-OR: Medically Tailored Meals Lower Hemoglobin A1c: The Food as Medicine for Diabetes (FAME-D) Randomized Clinical Trial

Key Result

Medically tailored meals significantly lowered HbA1c compared with a food subsidy (7.74% vs 8.17%, MD -0.42%; 95% CI -0.82 to -0.03; p=0.037).

Key Points

This trial aimed to compare the effects of medically tailored meals and food subsidies on diabetes outcomes.
Randomized comparative effectiveness trial (NCT04828785) involving adults with type 2 diabetes and food insecurity.
Participants received either 10 tailored meals per week or a $40/month food subsidy for 6 months.
Lifestyle intervention included telephone support focused on healthy eating and behavior change.
At 6 months, HbA1c was significantly lower for the medically tailored meals group (7.74%) than the food subsidy group (8.17%), mean difference -0.42%, p=0.037.
Systolic blood pressure was also lower in the medically tailored meals group (124.3 mmHg) compared to the food subsidy group (130.8 mmHg), mean difference -6.5, p=0.02.
No significant differences in diastolic blood pressure and weight between groups.

Study Design

Type

RCT (n=194)

Randomization

Randomized

Structured PICO

Do medically tailored meals reduce HbA1c in adults with type 2 diabetes and food insecurity compared to a food subsidy?

Population

194 adults with type 2 diabetes and food insecurity, followed for 6 months.

Intervention

Medically tailored meals (MTM) consisting of home delivery of 10 meals/week tailored to T2D diet guidelines by a registered dietitian-nutritionist plus a telephone lifestyle intervention for 6 months.

Comparator

Food subsidy ($40/month for healthy groceries) for 6 months.

Outcome

Hemoglobin A1c (HbA1c) at 6 months from randomization.surrogate

In adults with type 2 diabetes and food insecurity, 6 months of medically tailored meals significantly lowered HbA1c and systolic blood pressure compared to a food subsidy.

Main Result

Mean Difference: -0.42 (95% CI -0.82–-0.03)

Absolute Event Rate: 7.74% vs 8.17%

p-value: p=0.037

Abstract

Introduction and Objective: Food insecurity leads to worse type 2 diabetes (T2D) outcomes, but which food insecurity intervention best improves T2D outcomes is unclear. Our objective was to compare the effectiveness of two food insecurity interventions: medically tailored meals (MTM) and food subsidies. Methods: Randomized comparative effectiveness trial (NCT04828785). Adults with T2D and food insecurity received either MTM (home delivery of 10 meals/week tailored to T2D diet guidelines by a registered dietitian-nutritionist + telephone lifestyle intervention adapted from Look AHEAD) or a food subsidy (40/month for healthy groceries) for 6 months. Lifestyle intervention (6 main sessions + 6 brief ‘check-ins’) focused on skills for healthy eating, increased activity, and behavior change with or without a weight loss goal (per participant preference). The primary outcome was hemoglobin A1c (HbA1c). Other outcomes were systolic and diastolic blood pressure (SBP and DBP), and weight. The primary timepoint was 6 months from randomization. Results: 194 participants were randomized. 178 (92%) had 6-month follow-up measurements. Mean age was 56 (SD: 12) years, 117 (60%) were women, 55 (28%) self-identified as Black, and 35 (18%) self-identified as Hispanic. Mean HbA1c at baseline was 8. 4 (SD: 1. 7) %, SBP was 132. 7 (SD: 19. 6) mmHg, DBP was 80. 1 (SD: 11. 7) mmHg, and weight was 103. 5 (SD: 24. 5) kg. At 6 months, HbA1c was significantly lower for MTM, compared with food subsidy (7. 74 vs. 8. 17, mean difference -0. 42%, 95% CI -0. 82 to -0. 03, p=0. 037). SBP was also lower (124. 3 vs. 130. 8 mmHg, mean difference -6. 5, 95% CI -12. 0 to -1. 1, p=0. 02). Differences for DBP (76. 1 vs. 78. 8 mmHg, mean difference -2. 7, 95% CI -5. 9 to 0. 5, p=0. 10) and weight (101. 6 vs. 102. 5 kg, mean difference -1. 0, 95% CI -2. 9 to 0. 9, p=0. 31) were not statistically significant. Conclusion: For adults with T2D and food insecurity, 6 months of MTM lowered HbA1c and SBP, compared with a food subsidy. Medically tailored meals can help improve health outcomes for people with food insecurity and T2D. Disclosure S. Berkowitz: Research Support; Current; Blue Cross Blue Shield North Carolina. K. A. Ricks: None. J. Terranova: Employee; Current; Community Servings. Research Support; Current; American Heart Association, National Institutes of Health. C. Dagley: None. B. Steiner: None. G. Kruse: Research Support; Current; AstraZeneca, Edwards Lifesciences Corporation. Stock/Shareholder; Current; Dimagi, Inc. T. C. Keyserling: None. J. B. Buse: Consultant; Current; Aardvark Therapeutics, Altimmune, Alveus Therapeutics, Amgen Inc. , Antag Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim International GmbH. Other - Consultant and clinical trial support; Current; Corcept Therapeutics. Consultant; Ended; Dexcom, Inc. Consultant; Current; Eli Lilly and Company. Consultant; Ended; embecta. Consultant; Current; General Medicines Inc. Other - Consultant and clinical trial support; Current; GentiBio. Consultant; Ended; Insulet Corporation. Consultant; Current; Kayothera. Other - Consultant and stock options; Current; Metsera. Other - Expert witness; Ended; Medtronic. Other - Consultant and investigator; Current; Novo Nordisk. Consultant; Current; Recordati S. p. A, Sparrow Pharmaceuticals. Consultant; Ended; Tandem Diabetes Care, Inc. Consultant; Current; Vertex Pharmaceuticals Incorporated, vTv Therapeutics, Zealand Pharma A/S. D. Wexler: Other - Data Monitoring Committee; Ended; Novo Nordisk. Other - Data Monitoring Committee; Current; Amgen Inc. L. M. Delahanty: Stock/Shareholder; Current; Omada Health, Inc. Stock/Shareholder; Ended; Jana Care Inc. Consultant; Current; ZOE Limited. Stock/Shareholder; Current; ZOE Limited. Funding NIH/NIDDK (R01DK125831)

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