CGM and DFU Healing Post-discharge

Emory University

Status: Enrolling

Conditions: Diabetic Foot; Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown

Treatments: Device: Real Time Continuous Glucose Monitoring (rt-CGM); Behavioral: Diabetes Education; Other: Fingerstick blood glucose (FBG) monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06054659

R03DK137007-01 (U.S. NIH Grant/Contract)

STUDY00006202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 more extensive than just a single toe during index hospitalization
• Patients with type 1 diabetes
• 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
• Subjects unwilling to wear a CGM device and/or monitor blood glucose with FBG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Real time - Continuous glucose monitoring

Experimental group

Description:

Participants will wear a CGM sensor in the abdomen or arm, placed by a study team before hospital discharge. Participants will have instructions on how to monitor BG with the CGM device and will use their glucometer and do fingersticks as needed for CGM calibration.

Treatment:

Other: Fingerstick blood glucose (FBG) monitoring

Behavioral: Diabetes Education

Device: Real Time Continuous Glucose Monitoring (rt-CGM)

Fingerstick blood glucose (FBG) monitoring

Active Comparator group

Description:

Participants randomized to this group will monitor blood glucose by performing fingersticks, they will also have the application of CGM but will not be given the receiver to allow for self-monitoring. CGM will only be applied by the research team for monitoring over a 14-day interval at baseline, week 4, week 8, and week 12. Blinding will continue throughout the study. This group will receive training only in home BG monitoring with FBG.

Treatment:

Other: Fingerstick blood glucose (FBG) monitoring

Behavioral: Diabetes Education