NCT06054659Completed
CGM and DFU Healing Post-discharge
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.
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 116 (actual)
- First submitted
- 19 Sept 2023
- Start date
- 20 Feb 2024
- Primary completion date
- 3 Mar 2026
- Lead sponsor
- Emory University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06054659
What you commit to
- Study type: Interventional
- Participants enrolled: 116
- From 20 Feb 2024 to the primary completion date, 3 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with type 1 diabetes
Lab values
- Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG
Age
- Age \< 18 years
Other
- 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 more extensive than just a single toe during index hospitalization
- Participants enrolled in another interventional clinical trial (including during the run-in period).
- 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
Who the study is looking for
- Adults aged 18 and over with type 2 diabetes admitted to the hospital 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 a single toe amputation
- 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
- 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Decatur Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.