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CGM and DFU Healing Post-discharge

NCT06054659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this study is to look at the benefits of using a Continuous Glucose Monitoring (CGM) system compared with standard-of-care testing for patients with type 2 diabetes and diabetic foot ulcers (DFU) and how this will improve wound healing.

The CGM system allows medical staff and patients with diabetes to monitor and make treatment decisions to improve glucose control, without the need for performing fingersticks. Hence, the use of CGM will decrease the painful and burdensome task of performing finger sticks several times per day and may prevent low blood glucose in patients with diabetes.

Conditions

  • Diabetic Foot
  • Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown

Interventions

DEVICE

Real Time Continuous Glucose Monitoring (rt-CGM)

Participants randomized to rt-CGM will have CGM placed before hospital discharge. They will also receive teaching from the research team on the proper use of their CGM sensor and reader. The study team will provide CGM devices, but subjects may use their glucometer for FBG testing as needed for CGM calibration.

OTHER

Fingerstick blood glucose (FBG) monitoring

Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).

BEHAVIORAL

Diabetes Education

Participants will receive standard-of-care diabetes education with a certified diabetes educator (CDE) prior to discharge (with the approval of the treating inpatient team).

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Maya Fayfman, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2026-03-03
Completion
2026-03-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054659 on ClinicalTrials.gov