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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Grady Health System
RECRUITING
Atlanta
Emory Decatur Hospital
ACTIVE_NOT_RECRUITING
Decatur
Contact Information
Primary
Maya Fayfman, MD
maya.fayfman@emory.edu
404-778-1664
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2026-01
Participants
Target number of participants: 92
Treatments
Experimental: Real time - Continuous glucose monitoring
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.
Active_comparator: Fingerstick blood glucose (FBG) monitoring
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Emory University

This content was sourced from clinicaltrials.gov