CGM and DFU Healing Post-discharge

Description

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 diabetes type 2 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

Talk to us

Study Overview

On this page

Study Details

Study overview

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 diabetes type 2 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.

A Randomized Controlled Open-label Study Comparing the Use of Real-time Continuous Glucose Monitoring (Rt-CGM) to Point of Care Testing (POCT) for Glycemic Monitoring in Patients Post-hospitalization for Diabetic Foot Ulcers.

CGM and DFU Healing Post-discharge

Condition
Diabetic Foot
Intervention / Treatment

-

Contacts and Locations

Atlanta

Grady Health System, Atlanta, Georgia, United States, 30303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults aged 18 and over with type 2 diabetes admitted to general medical and surgical services with diabetic foot ulceration with or without infection (cellulitis or osteomyelitis)
  • * HbA1c \>= 8.0% at the time of enrollment
  • * Treatment of diabetic foot ulcer with medical management and/or debridement
  • * Wound, Ischemia, foot Infection (WIfI) score of 1-3
  • * Duration of DFU less than 1 year
  • * Able and willing to use continuous glucose monitoring technology independently or with the assistance of a close relative or caretaker
  • * Age \< 18 years
  • * Homelessness or anticipated to have unstable housing after discharge
  • * A WIfI score of 4 denoting a very high risk for major amputation (above or below the knee) and very low odds of healing within 12 months
  • * Any amputation (major or minor) in the limb with a DFU during hospitalization
  • * Patients with type 1 diabetes
  • * Inability to participate in the informed consent process for any reason
  • * Female subjects who are pregnant or breastfeeding at the time of enrollment in the study
  • * Subjects planning to use CGM technology independent of the study following discharge
  • * Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Maya Fayfman, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2025-07