Diabetic FootNCT06054659
CGM and DFU Healing Post-discharge
A study testing Real Time Continuous Glucose Monitoring (rt-CGM), Fingerstick blood glucose (FBG) monitoring and Diabetes Education in people with Diabetic Foot and Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown
- What is being tested?
- Real Time Continuous Glucose Monitoring (rt-CGM), Fingerstick blood glucose (FBG) monitoring and Diabetes Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2024to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System
Atlanta, Georgia, 30303
Emory Decatur Hospital
Decatur, Georgia, 30033
About this study
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.
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.
Read the 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.
- Being tested
- Real Time Continuous Glucose Monitoring (rt-CGM), Fingerstick blood glucose (FBG) monitoring, Diabetes Education
- Keywords
- Continuous Glucose Monitoring (CGM) system, Time in Range, Fingerstick blood glucose testing, Wound healing, Real time - Continuous glucose monitoring
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Time Continuous Glucose Monitoring (rt-CGM)Device
Also called Intervention Group
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) monitoringOther
Also called Standard of Care (SOC) capillary glucose test
Participants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor).
Diabetes EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fingerstick blood glucose (FBG) monitoring; Behavioral: Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFU wound healing rates
Number of participants with DFU wound healing rates in both groups
Measured: up to 16 weeks post-discharge
Time to DFU healing
DFU healing will be assessed by two investigators blinded to the study intervention
Measured: up to 16 weeks post-discharge
Secondary outcomes (10)
Change in patient reported World Health Organization Well-Being Index
The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, with 0 representing the worst possible and 25 representing the best possible quality of life. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents the worst possible, whereas a score of 100 represents the best possible quality of life. A score below 13 indicates poor well-being and is an indication for testing for depression. In order to monitor possible changes in wellbeing, the percentage score is used. A 10% difference indicates a significant change.
Measured: Baseline and 16 weeks post-discharge
Change in patient reported diabetes distress scores (DDS)
The DDS yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress. To score, simply sum the patient's responses to the appropriate items and divide by the number of items in that scale. Current research suggests that a mean item score of 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.' Current research also indicates that associations between DDS scores and behavioral management and biological variables (e.g., A1C) occur with DDS scores of > 2.0. Clinicians may consider moderate or high distress worthy of clinical attention, depending on the clinical context.
Measured: Baseline and 16 weeks post-discharge
Change in patient reported CGM satisfaction (CGM-SAT)
CGM-SAT: This 44-item questionnaire was designed to measure the impact of using CGM on diabetes management and family relationships and on satisfaction with the emotional, behavioral, and cognitive effects of CGM use. Participants rate their agreement or disagreement on a 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 44 potential positive or negative effects of the use of the rated CGM device. Higher scores reflect a more favorable impact of, and satisfaction with, CGM use.
Measured: Baseline and 16 weeks post-discharge
Change in patient reported Glucose Monitoring Survey (GMS)
GMS is a 22-item scale constructed for this trial that quantifies respondents' satisfaction with and therapeutic impact of the glucose monitoring systems that they were currently using (SMBG alone or with CGM). The 22 two-part items ask the respondent to evaluate "Is this a problem now?" and then "How has it changed in the past 6 months?" Response options for the "Problem" questions range from 1 = "a lot" to 4 = "not at all," while those for the "Change" questions range from 1 = "worse" to 3 = "better." Higher scores on the "Problem" questions indicate more positive views of the rated glucose monitoring system. Higher scores on the "Change" questions indicate greater perceived improvement.
Measured: Baseline and 16 weeks post-discharge
Frequency of medication adjustments
The frequency of medication adjustments including initiation of new non-insulin-based therapy, basal and/or prandial insulin therapy, and/or dose adjustments will be documented during study participation.
Measured: Up to 16 weeks post discharge
Glycemic variability
Glycemic variability (GV) will be assessed by coefficient of variation (CV) and standard deviation from baseline and 12 weeks. Based on the published literature, the 2017 international consensus statement on the use of CGM suggested that 'stable glucose levels are defined as a CV <36% and unstable glucose levels are defined as CV ≥36%
Measured: Baseline and 16 weeks post-discharge
Relationship of time in range (TIR) and likelihood of healing
Time in Range (%TIR) is the percentage of time that a person spends with their blood glucose levels in a target range (70-180 mg/dL). A time-to-event (TTE) analysis will be conducted with the primary outcome based on time in range (%TIR) stratification among all study subjects. The stratification will be done for groups where %TIR ≥ 50 and %TIR < 50%.
Measured: Up to 16 weeks post discharge
Relationship of time below range (%TBR) and likelihood of healing
Healing rate compared to each %TBR level 1 (54 - < 70 mg/dL); %TBR Level 2 (BG<54 mg/dL)
Measured: Up to 16 weeks post discharge
Relationship of time above range (%TAR) and likelihood of healing
Healing rate compared to each %TAR level 1 (BG >180 - 250 mg/dL); %TAR level 2 (BG >250 mg/dL)
Measured: Up to 16 weeks post discharge
Relationship of glycemic variability and the likelihood of healing
Healing rate compared to GV
Measured: Up to 16 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Feb 2024
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Fayfman, Emory University
- Investigators
- Maya Fayfman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054659
- Sponsor's protocol ID
- STUDY00006202
- Other IDs
- R03DK137007-01, 2025P013076
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06054659
- Acronym / sponsor ID
- STUDY00006202
- Keywords
- Continuous Glucose Monitoring (CGM) system, Time in Range, Fingerstick blood glucose testing, Wound healing, Real time - Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real time - Continuous glucose monitoring | Experimental | Device: Real Time Continuous Glucose Monitoring (rt-CGM), Other: Fingerstick blood glucose (FBG) monitoring, Behavioral: Diabetes EducationParticipants 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. |
| Fingerstick blood glucose (FBG) monitoring | Active comparator | Other: Fingerstick blood glucose (FBG) monitoring, Behavioral: Diabetes EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real Time Continuous Glucose Monitoring (rt-CGM)Also: Intervention GroupParticipants 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. | Device | Real time - Continuous glucose monitoring |
| Fingerstick blood glucose (FBG) monitoringAlso: Standard of Care (SOC) capillary glucose testParticipants will use their own glucometer for FBG testing as advised by their treating provider (usually primary care or diabetes doctor). | Other | Fingerstick blood glucose (FBG) monitoring, Real time - Continuous glucose monitoring |
| Diabetes EducationParticipants will receive standard-of-care diabetes education with a certified diabetes educator (CDE) prior to discharge (with the approval of the treating inpatient team). | Behavioural | Fingerstick blood glucose (FBG) monitoring, Real time - Continuous glucose monitoring |
Primary outcome
DFU wound healing rates
Time frame: up to 16 weeks post-discharge
Number of participants with DFU wound healing rates in both groups
Time to DFU healing
Time frame: up to 16 weeks post-discharge
DFU healing will be assessed by two investigators blinded to the study intervention
10 secondary outcomes
Change in patient reported World Health Organization Well-Being Index
Time frame: Baseline and 16 weeks post-discharge
Change in patient reported diabetes distress scores (DDS)
Time frame: Baseline and 16 weeks post-discharge
Change in patient reported CGM satisfaction (CGM-SAT)
Time frame: Baseline and 16 weeks post-discharge
Change in patient reported Glucose Monitoring Survey (GMS)
Time frame: Baseline and 16 weeks post-discharge
Frequency of medication adjustments
Time frame: Up to 16 weeks post discharge
Glycemic variability
Time frame: Baseline and 16 weeks post-discharge
Relationship of time in range (TIR) and likelihood of healing
Time frame: Up to 16 weeks post discharge
Relationship of time below range (%TBR) and likelihood of healing
Time frame: Up to 16 weeks post discharge
Relationship of time above range (%TAR) and likelihood of healing
Time frame: Up to 16 weeks post discharge
Relationship of glycemic variability and the likelihood of healing
Time frame: Up to 16 weeks post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.
Related trials for Diabetic Foot
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Fayfman, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Time Continuous Glucose Monitoring (rt-CGM), Fingerstick blood glucose (FBG) monitoring and Diabetes Education in people with Diabetic Foot and Diabetes Type 2 With Diabetic Ulcer of Toe, Skin Breakdown, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFU wound healing rates (time frame: up to 16 weeks post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.