Trial Outcomes & Findings for Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults (NCT NCT05352230)
NCT ID: NCT05352230
Last Updated: 2025-08-01
Results Overview
To determine the feasibility and acceptance of CGM in adults with diabetes who underwent kidney transplantation compared to those who use glucometers.
TERMINATED
NA
4 participants
32 weeks
2025-08-01
Participant Flow
A total of ten participants were screened for eligibilty between April of 2023 and October of 2023
A total of 4 participants were randomized. Of those not randomized, 6 did not meet inclusion/exclusion criteria
Participant milestones
| Measure |
Continue Glucose Monitoring (CGM), Then Standard Glucometer
External diabetes device glucose sensor that measures interstitial glucose levels every minute
Free style libre-2: 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
|
Glucometer, Then Continuous Gluose Monitoring (CGM)
Device that measures capillary blood glucose levels
Free style libre-2: 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
|
|---|---|---|
|
First Intervention (3 Months)
STARTED
|
2
|
2
|
|
First Intervention (3 Months)
COMPLETED
|
0
|
0
|
|
First Intervention (3 Months)
NOT COMPLETED
|
2
|
2
|
|
Washout (2 Months)
STARTED
|
0
|
0
|
|
Washout (2 Months)
COMPLETED
|
0
|
0
|
|
Washout (2 Months)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Months)
STARTED
|
0
|
0
|
|
Second Intervention (3 Months)
COMPLETED
|
0
|
0
|
|
Second Intervention (3 Months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Continue Glucose Monitoring (CGM), Then Standard Glucometer
External diabetes device glucose sensor that measures interstitial glucose levels every minute
Free style libre-2: 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
|
Glucometer, Then Continuous Gluose Monitoring (CGM)
Device that measures capillary blood glucose levels
Free style libre-2: 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
|
|---|---|---|
|
First Intervention (3 Months)
study terminated
|
2
|
2
|
Baseline Characteristics
Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults
Baseline characteristics by cohort
| Measure |
Continue Glucose Monitoring (CGM), Then Glucometer
n=2 Participants
External diabetes device glucose sensor that measures interstitial glucose levels every minute for 12 weeks, followed by standard glucometer that measures capillary blood glucose levels for 12 weeks with an 8 week wash out period in between
|
Glucometer, Then Continuous Glucose Monitoring (CGM)
n=2 Participants
Device that measures capillary blood glucose levels for 12 weeks followed by an external diabetes device glucose sensor that measures interstitial glucose levels every minute for 12 weeks with an 8 week wash out period in between
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 1 • n=5 Participants
|
58 years
STANDARD_DEVIATION 4 • n=7 Participants
|
55 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 32 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
To determine the feasibility and acceptance of CGM in adults with diabetes who underwent kidney transplantation compared to those who use glucometers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 32 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksPopulation: study terminated early before outcomes are collected
kidney function marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 32 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
kidney function marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 32 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 32 weeksPopulation: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
glycemic marker
Outcome measures
Outcome data not reported
Adverse Events
Continue Glucose Monitoring (CGM)
Glucometer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place