CGM and DFU Healing Post-discharge

NCT06054659 | Completed FDA Device

• 3 other identifiers: STUDY00006202R03DK137007-012025P013076
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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 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.

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

Outcome Measures

Primary Outcomes (2)

• DFU wound healing rates

  Number of participants with DFU wound healing rates in both groups

  up to 16 weeks post-discharge

• Time to DFU healing

  DFU healing will be assessed by two investigators blinded to the study intervention

  up to 16 weeks post-discharge

Secondary Outcomes (10)

• Change in patient reported World Health Organization Well-Being Index

  Baseline and 16 weeks post-discharge

• Change in patient reported diabetes distress scores (DDS)

  Baseline and 16 weeks post-discharge

• Change in patient reported CGM satisfaction (CGM-SAT)

  Baseline and 16 weeks post-discharge

• Change in patient reported Glucose Monitoring Survey (GMS)

  Baseline and 16 weeks post-discharge

• Frequency of medication adjustments

  Up to 16 weeks post discharge

Study Arms (2)

Real time - Continuous glucose monitoring

EXPERIMENTAL

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.

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

Fingerstick blood glucose (FBG) monitoring

ACTIVE COMPARATOR

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.

Other: Fingerstick blood glucose (FBG) monitoring; Behavioral: Diabetes Education

Interventions

Real Time Continuous Glucose Monitoring (rt-CGM) DEVICE

Participants randomized to rt-CGM will have CGM placed before hospital discharge. They will also receive teaching from the research team on the proper use of their CGM sensor and reader. The study team will provide CGM devices, but subjects may use their glucometer for FBG testing as needed for CGM calibration.

Also known as: Intervention Group

Real time - Continuous glucose monitoring

Fingerstick blood glucose (FBG) monitoring OTHER

Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).

Also known as: Standard of Care (SOC) capillary glucose test

Fingerstick blood glucose (FBG) monitoring; Real time - Continuous glucose monitoring

Diabetes Education BEHAVIORAL

Participants will receive standard-of-care diabetes education with a certified diabetes educator (CDE) prior to discharge (with the approval of the treating inpatient team).

Fingerstick blood glucose (FBG) monitoring; Real time - Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maya Fayfman, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 20, 2024
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data will be made available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Individual participant data will be made available for sharing with researchers who provide a methodologically sound proposal. The proposal should be directed to maya.fayfman@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)