CGM for Diabetes after Kidney Transplant

Overseen By Clinical Research Coordinators

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must be taking: Insulin

Must not be taking: Hydroxyurea

Disqualifiers: Type 1 diabetes, Visual impairment, Pregnancy, Cardiovascular disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a continuous glucose monitor (CGM) can help manage blood sugar levels in people with Type 2 Diabetes who have had a kidney transplant. Researchers seek to determine if using CGM improves the time spent in the ideal blood sugar range compared to traditional fingerstick testing. Participants will either use a CGM device, such as the Dexcom G6, or continue with regular blood sugar checks. Individuals with Type 2 Diabetes who are on insulin and have had a kidney transplant within the past year might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes post-transplant.

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

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking hydroxyurea.

What prior data suggests that the Dexcom G6 CGM System is safe for use in diabetic kidney transplant patients?

Research has shown that the Dexcom G6 continuous glucose monitoring system is generally safe for people with diabetes. Studies have found that individuals can use it comfortably, even after a kidney transplant, with no major safety concerns reported.

One study compared the accuracy of the Dexcom G6 to regular blood sugar checks performed by individuals. The results suggested that the Dexcom G6 provides reliable blood sugar readings, aiding in effective diabetes management without causing harm.

The Dexcom G6 also includes a "blinded sensor" version, which functions similarly but does not display real-time data to the user. This version collects information without influencing the user's actions based on the readings.

Overall, Dexcom G6 devices are considered safe and well-tolerated, making them a suitable option for managing diabetes, even post-kidney transplant. Always consult healthcare providers for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Dexcom G6 for people with diabetes after a kidney transplant because it offers a more dynamic and less invasive way to monitor blood sugar levels compared to the standard fingerstick method. Unlike traditional self-monitoring, which requires at least four finger pricks a day, the Dexcom G6 continuously tracks glucose levels and alerts users in real-time to any significant changes. This continuous glucose monitoring can help patients maintain better control over their blood sugar without the constant hassle and discomfort of fingersticks. Moreover, this technology can catch fluctuations that might be missed with less frequent checks, potentially improving overall diabetes management.

What evidence suggests that the Dexcom G6 CGM System is effective for glycemic control in diabetic kidney transplant patients?

Research has shown that the Dexcom G6 continuous glucose monitoring (CGM) system helps people with diabetes who have had a kidney transplant maintain more stable blood sugar levels. In this trial, participants in the intervention arm will use the Dexcom G6 CGM system, which studies have found effective in keeping blood sugar within the target range of 70-180 mg/dL. This stability can reduce the risk of complications from high or low blood sugar. The Dexcom G6 provides real-time information, enabling users to quickly address any blood sugar issues. Experts in kidney and diabetes care agree that CGM is a promising tool for managing diabetes in kidney transplant patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Ling Chen, MD

Principal Investigator

UCDavis Transplant Nephrology

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 Diabetes who use insulin and have had a kidney transplant within the last year. Participants need functioning kidneys, access to home Wi-Fi, and must be able to test their blood sugar four times daily if using the blinded CGM. It's not for those with Type 1 Diabetes, unstable heart disease, active cancer treatment, significant visual or cognitive issues, or women who are pregnant/breastfeeding.

Inclusion Criteria

Access to home wi-fi connection

I have Type 2 Diabetes and am taking insulin.

I had a kidney transplant within the last year and my kidney is working well.

Exclusion Criteria

I have heart problems that are not well-controlled.

Prisoners

You are not able to wear the Dexcom G6 device all the time for any reason.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will either use continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG) for glycemic control

10 weeks

Regular monitoring with CGM or SMBG

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G6
• Dexcom G6 blinded sensor

Trial Overview The study examines how continuous glucose monitoring (CGM) affects blood sugar control in diabetic kidney transplant patients. The Dexcom G6 device will be used to monitor glucose levels continuously to see if it helps maintain them within a target range.

How Is the Trial Designed?

Group I: Continuous glucose monitoring (CGM) Active Control 1 Intervention

Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Group II: Self monitoring of blood glucose (fingersticks) Placebo Group 1 Intervention

The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.

Dexcom G6 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Dexcom G6 for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control in diabetic patients

Approved in European Union as Dexcom G6 for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control in diabetic patients

Approved in Canada as Dexcom G6 for:

• Type 1 diabetes
• Type 2 diabetes
• Glycemic control in diabetic patients

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Dahlia M Zuidema

Lead Sponsor

Trials

1

Recruited

80+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

The Abbott Freestyle Libre 1 glucose monitoring system demonstrated superior accuracy in adults undergoing hemodialysis, with a mean absolute relative difference (MARD) of 11.3% compared to 22.7% for the Dexcom G6, based on a study of 40 participants.

The Freestyle Libre 1 also showed a high percentage of readings within acceptable accuracy ranges, with 73.5% of readings within 15 mg/dL of reference values, indicating it is a reliable tool for glucose monitoring in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accuracy of Continuous Glucose Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA Study). Avari, P., Tang, W., Jugnee, N., et al.[2023]

The analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

The Dexcom G6 continuous glucose monitoring system demonstrated acceptable accuracy during elective abdominal surgery, with a mean absolute relative difference of 12.7% between sensor readings and reference glucose values, based on 1207 data pairs from 20 adults.

No clinically significant adverse events were reported, indicating that the Dexcom G6 is a safe option for peri-operative glucose management in patients with (pre)diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. Tripyla, A., Herzig, D., Joachim, D., et al.[2021]

The Dexcom G4 Platinum with Software 505 algorithm (SW505) demonstrated significantly better accuracy and performance compared to the original G4 Platinum system (G4P) in youth with diabetes, with a mean absolute relative difference (MARD) of 10% for SW505 versus 17% for G4P when compared to reference measurements.

Both systems were found to be safe, with no serious adverse events reported, but the improved accuracy of SW505 has the potential to enhance glucose management and glycemic outcomes in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Laffel, L.[2018]

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

Flash glucose monitoring (FGM) is highly accurate and convenient for post-kidney transplant patients, showing a strong correlation (0.95) with traditional capillary blood glucose monitoring, while being quicker and less expensive.

Both patients and nursing staff preferred FGM over traditional methods, reporting high satisfaction with its usability, and it took significantly less time to perform (3.6 seconds for FGM vs. 64 seconds for CBGM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and nursing experience of flash glucose monitoring following kidney transplantation. Shaban, AA., Minas, K., Sunderland, A., et al.[2023]

In a study of 25 pediatric patients who underwent total pancreatectomy with islet autotransplantation, the Dexcom G6 continuous glucose monitor (CGM) demonstrated clinically acceptable accuracy for glucose monitoring in the immediate postoperative period, with 100% of values deemed clinically acceptable.

The Dexcom G6 showed a mean absolute difference (MAD) of 14.7 mg/dL and a mean absolute relative difference (MARD) of 13.4%, indicating it can be a reliable tool for managing hyperglycemia, which is crucial for islet cell survival after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model. Segev, N., Hornung, LN., Tellez, SE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485880/

Continuous glucose monitoring (Dexcom g6) in people ... The study aimed to evaluate glycemic profiles using the Dexcom G6 CGM system for 30 d a personal smartphone in people with diabetes after kidney transplantation ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39392129/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1LyCSa7Du4sCC9vnA-tZbPfRwdZEN8YKtWs_N_KHX2idBXoUoy&fc=20230328035631&ff=20241011135403&v=2.18.0.post9+e462414

Continuous glucose monitoring (Dexcom g6) in people ... Conclusions: CGM systems seem to be a promising method for assessing glycemic control in people with diabetes after kidney transplantation.

3. researchgate.net researchgate.net/publication/384846914_Continuous_glucose_monitoring_Dexcom_g6_in_people_with_diabetes_after_kidney_transplantation

Continuous glucose monitoring (Dexcom g6) in people ... Conclusions CGM systems seem to be a promising method for assessing glycemic control in people with diabetes after kidney transplantation.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04783441

NCT04783441 | Use of CGM in Kidney Transplant Recipients The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg/ ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/19322968241292041

Consensus Report on the Use of Continuous Glucose ... This report represents the conclusions of 15 experts in nephrology and endocrinology, based on their knowledge of key studies and evidence in the field.

6. dexcom.com dexcom.com/en-us/safety-information

CGM Safety Information Read essential safety information on all of Dexcom's continuous glucose monitoring systems and software.

7. liebertpub.com liebertpub.com/doi/10.1177/15209156251368934

Accuracy of Dexcom G6 Pro and G7 Continuous Glucose ... This study aimed to examine the accuracy of the G6 Pro and G7 CGM systems (Dexcom, Inc.) compared with self-monitored blood glucose (SMBG) in a ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11607725/

Consensus Report on the Use of Continuous Glucose ... This report represents the conclusions of 15 experts in nephrology and endocrinology, based on their knowledge of key studies and evidence in the field.