Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults

NCT05352230 | Terminated Results FDA Device

• 1 other identifier: IRB-300009227
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-existing diabetes prior KT and Early Post-Transplant Hyperglycemia (PTRH) defined as a fasting blood glucose greater than or equal to 126 mg/dL or random glucose greater than or equal to 200 mg/dL or requirement of insulin during the first 45 days after KT has been associated with increased risks of post-transplant organ rejection. PTRH has also been associated to high infection rates, and in some cases, early mortality. The use of continuous glucose monitoring (CGM) compared with blood glucose meter monitoring in non-transplant patients with diabetes resulted in lower HbA1C by 0.4 to 0.5% within the first three months of use without major changes in patients' antidiabetic regimen, possibly due to patients become more conscious about their diabetes status and diet. CGM free style libre-2 measures the interstitial fluid every minute and their glucose sensors are replaced every two weeks. To our knowledge there are no studies that assess the role of CGM in improving glycemic and transplant outcomes in solid organ transplant patients, mainly because access to CGM is often limited by inadequate health insurance coverage or high out-of-pocket costs. The investigators hypothesize that the intervention will be feasible and acceptable to patients, and our overarching hypothesis is that patients who wear a CGM will have better glycemic control, using a proxy measure of lower fructosamine/albumin ratio and better CGM-parameters, compared to those who did not wear it. Fructosamine represents the average glycemia for the 2 to 3 weeks prior. It is useful in any situation where glycemic control needs to be assessed over a period shorter than a month and in cases involving interference in the HbA1C measurement such as in adults with KT due to shorter red blood cell lifespan related to anemia of chronic disease. Fructosamine values vary in relation to the serum albumin concentration, which makes the fructosamine/albumin ratio the ideal physiologic measure for this pilot study . The investigators also hypothesize that patients who wear a CGM will have less microalbuminuria compared to those who did not wear it.

Conditions

Diabetes Mellitus; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Compliance

  To determine the feasibility and acceptance of CGM in adults with diabetes who underwent kidney transplantation compared to those who use glucometers.

  32 weeks

Secondary Outcomes (8)

• Fructosamine/Albumin Ratio

  20 weeks

• Fructosamine/Albumin Ratio

  32 weeks

• Microalbuminuria

  20 weeks

• Microalbuminuria

  32 weeks

• Glucose Management Indicator (GMI)

  20 weeks

Study Arms (2)

Continue Glucose Monitoring (CGM)

ACTIVE COMPARATOR

External diabetes device glucose sensor that measures interstitial glucose levels every minute

Device: Free style libre-2

Glucometer

OTHER

Device that measures capillary blood glucose levels

Device: Free style libre-2

Interventions

Free style libre-2 DEVICE

A cross-over design will allow estimation of feasibility and acceptability of patients using CGM vs patients using blood glucose meter monitoring (conventional therapy). The study will consist on two phases, the first will last three months, then it will be a two months of washout period followed by the crossover, then the second phase will last another three months. Patients in the conventional therapy group will also use masked CGM (CGM professional) during the first two and last two weeks of their study phase with the purpose of collecting CGM-parameters information. The cross over randomization will be stratified by donor type (live vs deceased) using a web-based randomization tool. During the washout period the patients will continue using blood glucose meter monitoring

Continue Glucose Monitoring (CGM); Glucometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 18 years
• patients with history of diabetes (either T1D, T2D or atypical diabetes forms)
• patients could be on insulin or not before transplantation

You may not qualify if:

• kidney-pancreas transplanted participants
• not currently using CGM (but could have used a year prior the transplant)
• mental conditions that prevent continuing with the study.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Orlando Gutierrez
• Organization: UAB

ogutierrez@uabmc.edu

2059962736

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 28, 2022
• Study Start: April 15, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Locations

US (1)