# Randomized controlled trial of continuous glucose monitoring compared to point of care glucose testing following hospital discharge on 12-week diabetic foot ulcer healing rates

> **NIH NIH R03** · EMORY UNIVERSITY · 2023 · $191,700

## Abstract

Diabetic foot ulcers (DFUs) are a devastating complication of diabetes that disproportionally impact
underserved populations. DFUs are a frequent cause of hospitalization and the leading cause of limb loss in
the United States. DFUs and resultant amputations are life-altering events associated with high depression
rates, loss of independence, and death. While the benefits of improved glycemic control have been well
demonstrated for other diabetes complications, it’s impact on DFU healing has not been adequately
investigated. Continuous glucose monitors (CGMs) have been shown to improve glycemic metrics (including
HbA1c and time in range) along with patient-reported outcomes for patients with type 1 and type 2 diabetes.
However, no studies to our knowledge have reported on CGM’s impact on diabetes complications. Real-time
CGM (rt-CGM) allows patients to closely monitor glycemic patterns without the burden of frequent finger sticks
and provide detailed measures that assist in both self-management and clinician guided therapeutic
interventions. For this R03 application, we propose a randomized controlled trial comparing rt-CGM to standard
of care point of care finger stick testing in patients with DFUs. We will enroll 96 subjects hospitalized with a
DFU randomized to each intervention arm starting post-discharge and continued for a 12 week follow up
period. We will follow a pragmatic real-world study design where patient self-management and medication
adjustments will be guided by a clinical diabetes specialist rather than by the research team. Our overall
hypothesis is that rt-CGM will increase 12-week DFU healing rates (Aim 1 primary outcome) by improving
glycemic control (Aim 2). Participants in the point of care group will have a blinded CGM allowing us to accrue
a robust dataset of glycemic controls metrics (time in range, time above and below range, and glycemic
variability) to investigate the associations between glycemic control and DFU healing. Lastly, we will test if rt-
CGM improves patient reported outcomes such as diabetes distress and self-efficacy (Aim 3). We will conduct
this trial at Grady Memorial Hospital, an Atlanta safety-net hospital where >250 people (80% Black) are
hospitalized with DFU annually. Our findings will address two important gaps in the literature: (1) Does
glycemic control improve DFU healing? (2) Does rt- CGM impact a diabetes complication? Importantly, we will
study these gaps in an underserved population that generally has lower access to health technologies such as
CGM. This proposal is a natural extension of my K23 which implement a pragmatic design to hospital
management of diabetes. During my K training, I co-founded a multidisciplinary team of clinician-researchers
based at Grady Memorial Hospital, whose mission is to improve diabetic foot care to reduce amputations. With
support from this team and ongoing support from my mentor, this study will pave the way to becoming an
independent investigator. The fin...

## Key facts

- **NIH application ID:** 10727731
- **Project number:** 1R03DK137007-01
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Maya Fayfman
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $191,700
- **Award type:** 1
- **Project period:** 2023-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10727731

## Citation

> US National Institutes of Health, RePORTER application 10727731, Randomized controlled trial of continuous glucose monitoring compared to point of care glucose testing following hospital discharge on 12-week diabetic foot ulcer healing rates (1R03DK137007-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10727731. Licensed CC0.

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