CGM for Diabetic Foot Ulcers

Overseen By Gerardo Blanco, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Type 1 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

92 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a Continuous Glucose Monitoring system to help manage diabetes, so you may not need to change your current medication routine.

What data supports the effectiveness of the treatment for diabetic foot ulcers?

Real-time continuous glucose monitoring (RT-CGM) helps people with diabetes better manage their blood sugar levels by providing detailed information on glucose patterns, which can lead to improved treatment decisions and potentially reduce diabetes complications. ^{1 2 3 4 5}

Is real-time continuous glucose monitoring (RT-CGM) safe for humans?

Real-time continuous glucose monitoring (RT-CGM) is generally considered safe for humans, though some users may experience mild discomfort or skin irritation. It is important to understand how to use the device properly to avoid issues like false alarms or missed low blood sugar events. ^{1 2 5 6 7}

How does the treatment Real Time Continuous Glucose Monitoring (rt-CGM) differ from other treatments for diabetic foot ulcers?

Real Time Continuous Glucose Monitoring (rt-CGM) is unique because it continuously tracks glucose levels, providing detailed patterns and trends that help manage diabetes more effectively. This can lead to better treatment decisions and potentially reduce complications, unlike traditional methods that may not offer such comprehensive data. ^{1 2 5 8 9}

What is the purpose of this trial?

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 diabetes type 2 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.

Research Team

Maya Fayfman, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults over 18 with type 2 diabetes and diabetic foot ulcers (DFUs) that are not at very high risk of amputation. Participants should have a HbA1c level of at least 8.5% and be able to use CGM technology either by themselves or with help. Pregnant or breastfeeding women, those who've used CGM before, or have severe arterial disease aren't eligible.

Inclusion Criteria

Able and willing to use continuous glucose monitoring technology independently or with the assistance of a close relative or caretaker

I am receiving treatment for a diabetic foot ulcer.

My foot ulcer has been present for less than a year.

Exclusion Criteria

You don't want to wear a continuous glucose monitoring device or check your blood sugar levels.

My condition has a high risk of needing a major leg amputation.

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either real-time continuous glucose monitoring (rt-CGM) or point of care testing (POCT) for glycemic monitoring. CGM sensors are applied and monitored at baseline, week 4, week 8, and week 12.

16 weeks

4 visits (in-person) at 4, 8, 12, and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of final wound outcomes and patient-reported outcomes.

4 weeks

Treatment Details

Interventions

• Diabetes Education
• Real Time Continuous Glucose Monitoring (rt-CGM)

Trial Overview The study compares the effectiveness of Continuous Glucose Monitoring (CGM) systems against standard fingerstick blood glucose monitoring in improving wound healing for diabetic foot ulcers post-discharge from medical services.

Participant Groups

Group I: Real time - Continuous glucose monitoring Experimental Treatment 3 Interventions

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

Group II: Fingerstick blood glucose (FBG) monitoring Active Control 2 Interventions

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.

Real Time Continuous Glucose Monitoring (rt-CGM) is already approved in United States, European Union for the following indications:

Approved in United States as rt-CGM for:

• Diabetes management
• Diabetic foot ulcer management

Approved in European Union as rt-CGM for:

• Diabetes management
• Diabetic foot ulcer management

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Real-time continuous glucose monitoring (RT-CGM) is a valuable tool for diabetes management, helping to detect nocturnal or unrecognized hypoglycemia and improve treatment decisions, which can enhance metabolic control and reduce diabetes complications.

Despite some limitations like lag time and the need for calibration, RT-CGM devices are generally accurate and user-friendly, making it feasible to implement a clinical RT-CGM program with proper patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time continuous glucose monitoring in the clinical setting: the good, the bad, and the practical. Mamkin, I., Ten, S., Bhandari, S., et al.[2021]

In a study involving 72 insulin-treated patients with type 2 diabetes, the use of real-time continuous glucose monitoring (RT-CGM) significantly reduced the number of hypoglycemic events compared to traditional point-of-care testing, with fewer patients experiencing low blood sugar levels.

The RT-CGM group not only had fewer overall hypoglycemic events but also experienced less time spent in dangerously low glucose ranges, demonstrating its potential as a safer monitoring method for high-risk patients in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Singh, LG., Satyarengga, M., Marcano, I., et al.[2021]

In a study of 65 patients with poorly controlled type 2 diabetes, those using a real-time continuous glucose monitoring system (RT-CGM) showed a significant reduction in HbA1c levels from 9.1% to 8.0% over 12 weeks, compared to a smaller reduction in the self-monitoring blood glucose (SMBG) group.

The RT-CGM group also experienced improvements in lifestyle factors, including reduced calorie intake, weight loss, lower body mass index (BMI), and increased exercise time, indicating that RT-CGM not only aids in glucose control but also promotes healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Yoo, HJ., An, HG., Park, SY., et al.[2022]

A program for real-time continuous glucose monitoring (rtCGM) in hospitalized patients with diabetes showed a mean absolute relative difference (MARD) of 10.3% when compared to traditional blood glucose measurements, indicating good accuracy for monitoring glucose levels.

The study found that 99.2% of rtCGM data points were clinically acceptable, suggesting that while rtCGM can effectively alert for hypoglycemia, insulin dosing should still rely on fingerstick measurements to avoid potential discrepancies in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes. Baker, M., Musselman, ME., Rogers, R., et al.[2022]

Real-time continuous glucose monitoring (RT-CGM) significantly reduces HbA1c levels in patients with type 1 diabetes compared to self blood glucose measurement (SBGM), based on a systematic review of 7 randomized controlled trials involving 948 participants.

The use of RT-CGM does not increase the risk of major hypoglycemic episodes, and consistent use (over 60-70% of the time) is linked to better glucose control, indicating its safety and efficacy in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. Szypowska, A., Ramotowska, A., Dzygalo, K., et al.[2022]

The real-time continuous glucose monitoring system (RT-CGMS) was found to be safe and accurate in monitoring glucose levels in patients undergoing cardiothoracic surgery, with 96.6% of sensor values aligning with accepted accuracy standards.

The activation of the alarm function on the RT-CGMS did not significantly impact glucose control, indicating that further research is needed to understand its potential benefits in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. Logtenberg, SJ., Kleefstra, N., Snellen, FT., et al.[2009]

Real-time continuous glucose monitoring (RT-CGM) devices significantly enhance diabetes management by providing detailed glucose patterns and alerts for both high and low blood sugar levels, which can lead to better daily control for patients.

Effective use of RT-CGM requires patient education on key issues such as the physiological lag in glucose readings, proper use of alarm settings, and the risk of hypoglycemia from over-correcting blood sugar levels after meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a continuous glucose monitoring program. Wolpert, H.[2021]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

In a study involving 27 subjects over 14 days, the Dexcom G5 Mobile (rtCGM) demonstrated higher accuracy than the FreeStyle Libre (isCGM), with 91.5% of its readings within ±20% of laboratory results compared to 82.5% for FreeStyle Libre.

The mean absolute relative difference (MARD) was lower for the Dexcom G5 at 9.5%, indicating it provided more precise glucose readings than the FreeStyle Libre, which had a MARD of 13.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. Link, M., Kamecke, U., Waldenmaier, D., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-time continuous glucose monitoring in the clinical setting: the good, the bad, and the practical. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Establishing a continuous glucose monitoring program. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. [2021]