Clinical trial NCT06054659: CGM and DFU Healing Post-discharge
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown
Keywords: Continuous Glucose Monitoring (CGM) system
Time in Range
Fingerstick blood glucose testing
Wound healing
Real time - Continuous glucose monitoring
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: The goals of this study are to compare differences in patients with diabetic foot ulcer (DFU) wound healing using continuous glucose monitor (CGM) and point of care testing (POCT) at 16 weeks post-hospital discharge. The study is important to support the limited data available to optimize glycemic control DFU healing and the use of CGM. Patients with type 2 diabetes (T2D) and HbA1c \> 8.5% admitted to general medicine and surgery services with diabetic foot ulcers will be approached for study participation.

After completing the informed consent process, patients will be randomized 1:1 to glucose monitoring with real-time CGM (rt-CGM) or POCT. Before discharge, participants in the rt-CGM group will have CGM applied by the research team with instructions on how to monitor blood glucose (BG) with the CGM device. Participants enrolled in the POCT group will have the application of a blinded CGM that will monitor glycemic control, but results will not be visible to the participant, clinical team, or research providers. Participants will receive standard diabetes education. Participants will be scheduled for research visits at 4, 8, 12, and 16 weeks. CGM sensors will be provided at these visits with a review of application, monitoring, and removal. Subjects in both groups will not receive specific guidelines on medication or other interventions. At the end of the 16-week study period, an assessment of final wound outcomes will be made by either the podiatry or infectious diseases collaborators (one of whom will have already been following the patient clinically) during one of the routine clinical visits. Photos of the ulcer site will be taken at the 16-week study visit, and the outcome will be reported by the treating wound care provider and adjudicated by a member of the study team who is blinded to the patient's clinical information and intervention arm. Participants will complete surveys to assess patient-reported outcomes relating to depression, CGM satisfaction, and self-efficacy.

Eligibility criteria: 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 \>= 8.0% 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: DFU wound healing rates
timeFrame: up to 16 weeks post-discharge
measure: Time to DFU healing
timeFrame: up to 16 weeks post-discharge
Secondary outcomes:
measure: Change in patient reported World Health Organization Well-Being Index
timeFrame: Baseline and 16 weeks post-discharge
measure: Change in patient reported diabetes distress scores (DDS)
timeFrame: Baseline and 16 weeks post-discharge
measure: Change in patient reported CGM satisfaction (CGM-SAT)
timeFrame: Baseline and 16 weeks post-discharge
measure: Change in patient reported Glucose Monitoring Survey (GMS)
timeFrame: Baseline and 16 weeks post-discharge
measure: Frequency of medication adjustments
timeFrame: Up to 16 weeks post discharge
measure: Glycemic variability
timeFrame: Baseline and 16 weeks post-discharge
measure: Relationship of time in range (TIR) and likelihood of healing
timeFrame: Up to 16 weeks post discharge
measure: Relationship of time below range (%TBR) and likelihood of healing
timeFrame: Up to 16 weeks post discharge
measure: Relationship of time above range (%TAR) and likelihood of healing
timeFrame: Up to 16 weeks post discharge
measure: Relationship of glycemic variability and the likelihood of healing
timeFrame: Up to 16 weeks post discharge
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Maya Fayfman, MD
role: PRINCIPAL_INVESTIGATOR
References: