Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2024-02-20
2026-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Real Time Continuous Glucose Monitoring (rt-CGM)
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.
Fingerstick blood glucose (FBG) monitoring
Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).
Diabetes Education
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
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.
Fingerstick blood glucose (FBG) monitoring
Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).
Diabetes Education
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).
Interventions
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Real Time Continuous Glucose Monitoring (rt-CGM)
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.
Fingerstick blood glucose (FBG) monitoring
Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).
Diabetes Education
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER
Responsible Party
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Maya Fayfman
Associate Professor
Principal Investigators
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Maya Fayfman, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Health System
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00006202
Identifier Type: -
Identifier Source: org_study_id
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