CGM and DFU Healing Post-discharge
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
🗓️ Study Start (Actual) 20 February 2024
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 102
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion 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 \>= 8.5% at 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

    Exclusion Criteria:

    • * Age \< 18 years
    • * A WIfI score of 4 denoting 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
    • * Clinically significant peripheral arterial disease where revascularization is indicated
    • * 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 using CGM technology prior to admission
    • * Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 September 2023
  • First Submitted that Met QC Criteria 19 September 2023
  • First Posted 26 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 March 2024
  • Last Update Posted 6 March 2024
  • Last Verified March 2024