RECRUITING

CGM and DFU Healing Post-discharge

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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.

Quick Facts

Study Start:2024-02-20
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06054659

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 and over with type 2 diabetes admitted to the hospital with diabetic foot ulceration with or without infection (cellulitis or osteomyelitis)
  2. * HbA1c \>= 8.0% at the time of enrollment
  3. * Treatment of diabetic foot ulcer with medical management and/or a single toe amputation
  4. * Patients with prior amputation at or below the ankle may be enrolled if they develop an ulceration in the foot that is not felt to be a surgical wound from prior amputation, defined as a healed surgical site for at least 6 weeks after the surgery before the onset of the new ulceration
  5. * Wound, Ischemia, foot Infection (WIfI) score of 1-3
  6. * Duration of DFU less than 1 year
  7. * Able and willing to use continuous glucose monitoring technology independently or with the assistance of a close relative or caretaker
  1. * Age \< 18 years
  2. * Homelessness or anticipated to have unstable housing after discharge
  3. * 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
  4. * Any amputation more extensive than just a single toe during index hospitalization
  5. * Patients with type 1 diabetes
  6. * Participants enrolled in another interventional clinical trial (including during the run-in period).
  7. * Inability to participate in the informed consent process for any reason
  8. * Female subjects who are pregnant or breastfeeding at the time of enrollment in the study
  9. * Subjects planning to use CGM technology independent of the study following discharge
  10. * Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG

Contacts and Locations

Study Contact

Maya Fayfman, MD
CONTACT
404-778-1664
maya.fayfman@emory.edu

Principal Investigator

Maya Fayfman, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Health System
Atlanta, Georgia, 30303
United States
Emory Decatur Hospital
Decatur, Georgia, 30033
United States

Collaborators and Investigators

Sponsor: Emory University

  • Maya Fayfman, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Continuous Glucose Monitoring (CGM) system
  • Time in Range
  • Fingerstick blood glucose testing
  • Wound healing
  • Real time - Continuous glucose monitoring

Additional Relevant MeSH Terms

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