Use of CGM in Kidney Transplant Recipients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or above
Received a kidney transplant within the past year with functioning kidney (eGFR > 30 mL/min
Person with Type 2 Diabetes and on insulin
Access to home wi-fi connection
Disqualifiers
Person with Type 1 Diabetes
Patients taking hydroxyurea
Patient unable to wear the Dexcom G6 device at all times for any reason
Must be able to test blood glucose with meter 4x a day when on blinded CGM.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexcom G6
Deviceaccess to continuous glucose monitoring in the Dexcom G6 arm 24/7
Dexcom G6 blinded sensor
Deviceretrospective access to continuous glucose profile after 10 days of wear
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Continuous glucose monitoring (CGM)Active comparator 1 intervention
Group B: Self monitoring of blood glucose (fingersticks)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time in Range (70-180 mg/dl)
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.
Time frame
70 daysSecondary outcomes
1
Glycemic variability
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
Time frame
70 days2
CGM satisfaction questionnaire (10 questions)
score on CGM questionnaire (1 = lowest and 5 = highest)
Time frame
up to 70 days3
Adherence to Diabetic Diet
Use of ASA24 online 24 hr dietary recall at 3 times throughout the study
Time frame
up to 70 days4
Incidence of all-cause emergency room utilization and rehospitalizations
during the study period (70 days)
Time frame
70 daysOther outcomes
1
safety endpoint Hypoglycemia
Hypoglycemia risk will be assessed as percentage of time below range (BG\<70 mg/dl) and very low (BG \<54 mg/dl).
Time frame
70 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
DexCom, Inc.
Collaborator
Source ClinicalTrials.gov