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Continuous Glucose Monitoring Device
CGM for Diabetes Post-Kidney Transplant
Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with history of diabetes (either T1D, T2D or atypical diabetes forms)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights
Study Summary
This trial will study the use of CGM for better glycemic control and transplant outcomes in adult patients with diabetes post kidney transplant.
Who is the study for?
This trial is for adults over 18 with a history of diabetes (Type 1, Type 2, or atypical forms) who have had a kidney transplant. It's not for those who've had both kidney and pancreas transplants, are already using continuous glucose monitoring (CGM), or have mental conditions that would interfere with study participation.Check my eligibility
What is being tested?
The trial is testing the FreeStyle Libre-2 CGM device in kidney-transplanted patients to see if it improves blood sugar control compared to standard blood glucose meters. The goal is better management of post-transplant hyperglycemia which can lead to complications.See study design
What are the potential side effects?
While specific side effects aren't mentioned for the FreeStyle Libre-2 CGM system, general issues may include skin irritation from sensor adhesive, inaccurate readings leading to mismanagement of diabetes, and potential discomfort during sensor application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a history of diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance
Secondary outcome measures
Glucose Management Indicator (GMI)
Time in Range (TIR) of 70 to 180 mg/dL
fructosamine/albumin ratio
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GlucometerExperimental Treatment1 Intervention
Device that measures capillary blood glucose levels
Group II: Continue Glucose Monitoring (CGM)Active Control1 Intervention
External diabetes device glucose sensor that measures interstitial glucose levels every minute
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,324 Total Patients Enrolled
15 Trials studying Diabetes
41,298 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of diabetes.I am older than 18 years.I have had a kidney and pancreas transplant.I may or may not have been on insulin before my transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Continue Glucose Monitoring (CGM)
- Group 2: Glucometer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Continue Glucose Monitoring (CGM) technology?
"The lack of data in relation to the efficacy and safety of CGM technology leads our team at Power to rate its safety a 1 on a scale from 1-3."
Answered by AI
Are there still participants being sought for this research endeavor?
"Clinicaltrials.gov specifies that this research endeavour is currently open to new participants, having been posted on April 15th 2023 and amended as recently as May 12th 2023."
Answered by AI
How great is the participation in this research effort?
"Indeed, the information accessible on clinicaltrials.gov suggests that this trial is currently trying to recruit candidates. It was first posted in April 15th 2023 and revised most recently on May 12th of the same year; it requires 30 participants from a single site."
Answered by AI
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