Use of CGM in Kidney Transplant Recipients

January 27, 2026 updated by: University of California, Davis

Continuous Glucose Monitoring (CGM) to Improve Glycemic Control 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/dL) in the Diabetic Kidney Transplant population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diabetes is one of the leading causes of End Stage Renal Disease (ESRD). Kidney transplantation is the best form of renal replacement therapy to date but requires that recipients of transplant organs maintain a complicated medication regimen in order to prevent graft loss. Their medications include lifelong immunosuppression, anti-microbials and other maintenance medications (i.e., anti-hypertensives, heart-protective regimens, bowel care, vitamins and pain medications).

For many transplant patients, glycemic control in the immediate post-operative period can be an additional challenge. Glycemic control may be hindered by recent surgery, corticosteroids, immunosuppressants, altered nutritional intake and reduced mobility.

Diabetes professional organizations such as the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) recommend continuous glucose monitoring (CGM) for anyone on intensive insulin therapy. The biggest benefit of CGM is not just the actual glucose value, but also its direction and rate of change. CGM data can also be downloaded and reflect patterns of glycemic control throughout the day and night, including not only the average blood glucose but also time-in-range (TIR) and degrees of glycemic variability. This can help identify unnotified nightly hypoglycemia or hyperglycemia and help titrate medications to achieve better glycemic control. Self-Management of blood glucose (SMBG) is a key component in effective glycemic management, but it places a large burden on the patient. Prior to CGM, SMBG was the only option to measure daily blood glucose fluctuations, but it is an imperfect tool. For patients on insulin, a blood glucose is checked at minimum 4 times per day, prior to meals and at bedtime. Additionally, the utility of SMBG can be endangered by patient decision making, the ability to check blood glucose, adherence to testing regimen, error due to poor testing technique, inadequate blood supply, contamination on fingers, or inaccuracy of some systems.

Numerous studies have shown the clinical benefit of CGM in the type-1 diabetes (T1D) and type-2 diabetes (T2D) populations (ref: Beck, Olafsdottir). The DIAMOND group (Beck) showed that CGM improved HBA1C and reduced hyperglycemia (BG>180). Patients wearing the CGM had high satisfaction scores and low perceived burden. CGM is still a new tool outside of the Type 1 Diabetes population but may have significant benefits for any patient on insulin. In Feb 2019 an international guideline on TIR (defined as blood glucose of 70-180 mg/dL) was published and TIR may become a new standard for assessing glycemic control.

The investigators research focuses on TIR and the benefits of CGM in the kidney transplant population. This can be essential for timely adjustments of insulin dosages when dealing with glycemic derangements and steroid induced hyperglycemia. CGM can provide an immense opportunity for a continuous 24/7 view of glucose values, glycemic variability, direction of change and unrecognized blood glucose levels during nighttime, and influence of food and activity on blood glucose values. In addition to the metrics described; the glucose management indicator (GMI) or also named estimated A1C (eA1C) is a measure converting the mean glucose from CGM using a formula derived from glucose readings from a population of individuals, into an estimate of a simultaneously measured laboratory A1C, this value may serve as an additional tool in assessing glycemic control. In conclusion: the use of a CGM can aid the provider and care team in better titration of insulin and medication regimen adjustment. This research hopes to give insight in a very complex population that has not had access to CGM before.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or above
  2. Received a kidney transplant within the past year with functioning kidney (eGFR > 30 mL/min
  3. Person with Type 2 Diabetes and on insulin
  4. Access to home wi-fi connection

Exclusion Criteria:

  1. Person with Type 1 Diabetes
  2. Patients taking hydroxyurea
  3. Patient unable to wear the Dexcom G6 device at all times for any reason
  4. Must be able to test blood glucose with meter 4x a day when on blinded CGM.
  5. Presence of clinically significant visual or cognitive impairment
  6. Illiterate
  7. Prisoners
  8. Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding
  9. Presence of clinically unstable cardiovascular disease
  10. Active malignancy treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous glucose monitoring (CGM)
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.
Device: Dexcom G6
access to continuous glucose monitoring in the Dexcom G6 arm 24/7
Placebo Comparator: Self monitoring of blood glucose (fingersticks)
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.
Device: Dexcom G6 blinded sensor
retrospective access to continuous glucose profile after 10 days of wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range (70-180 mg/dl)
Time Frame: 70 days
1) Time in Range: Number of minutes per day or percentage of time that glucose levels are in low (BG<70), target (BG 70-180), high (BG >180) or very high (BG>250) ranges.
70 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic variability
Time Frame: 70 days
assessed by the Coefficient of Variation (Glucose standard deviation divided by mean glucose). % CV is a standardized measure that assesses the magnitude of glucose variability
70 days
CGM satisfaction questionnaire (10 questions)
Time Frame: up to 70 days
score on CGM questionnaire (1 = lowest and 5 = highest)
up to 70 days
Adherence to Diabetic Diet
Time Frame: up to 70 days
Use of ASA24 online 24 hr dietary recall at 3 times throughout the study
up to 70 days
Incidence of all-cause emergency room utilization and rehospitalizations
Time Frame: 70 days
during the study period (70 days)
70 days
Incidence of post-transplant infections during study period
Time Frame: 70 days
during the study period (70 days)
70 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety endpoint Hypoglycemia
Time Frame: 70 days
Hypoglycemia risk will be assessed as percentage of time below range (BG<70 mg/dl) and very low (BG <54 mg/dl).
70 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

DexCom, Inc.

Investigators

  • Study Director: Ling Chen, MD, UCDavis Transplant Nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1554226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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