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isCGM + Education and coaching for Type 2 Diabetes (iCUDE Trial)
N/A
Waitlist Available
Led By Darren Lau, MD/PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 12 weeks
Awards & highlights
iCUDE Trial Summary
This trial will compare the effect of isCGM to usual care on HbA1c and other diabetes-related outcomes.
Eligible Conditions
- Type 2 Diabetes
iCUDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Secondary outcome measures
Diabetes self-care empowerment
Diabetes treatment satisfaction
Diabetes-related distress
+5 moreiCUDE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: isCGM with education and feedbackExperimental Treatment2 Interventions
Intervention subjects will receive three isCGM sensors (FreeStyle Libre 2, Abbott Laboratories) for use over weeks 1-6. They will have encounters with a diabetes educator for individualized education and coaching during weeks 1-2 and 5-6.
Group II: Enhanced usual care with education and feedback onlyActive Control1 Intervention
Enhanced usual care subjects will receive two encounters with a diabetes educator for individualized education and coaching, during weeks 1-2 and 5-6. They will not be provided with isCGM sensors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittently scanned continuous glucose monitor (isCGM)
2022
N/A
~110
Education and coaching
2022
N/A
~110
Find a Location
Who is running the clinical trial?
EPICORE CentreUNKNOWN
1 Previous Clinical Trials
64 Total Patients Enrolled
University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,853 Total Patients Enrolled
Epidemiology Coordinating and Research Centre, CanadaOTHER
3 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that is expected to limit your life to less than one year.Your average blood sugar level has been higher than 7.0% in the past 6 months.You are not using insulin for diabetes treatment.You have type 1 diabetes or a specific genetic form of diabetes called MODY.You have diabetes caused by taking steroids, and you have used steroids within the past 3 months.You cannot use the continuous glucose monitoring device because you are afraid of it or for any other reason.You are at least 18 years old and have type 2 diabetes.You must be living in your own home, not in a care facility.You have used continuous or real-time glucose monitoring in the past 6 months.You have difficulty with thinking and memory, as indicated by a certain test score.You have symptoms of sudden metabolic problems like extreme thirst, frequent urination, weight loss, and feeling very tired or having trouble breathing.You have not used insulin in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: isCGM with education and feedback
- Group 2: Enhanced usual care with education and feedback only
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.
Is there still capacity for participants within this experiment?
"According to the medical trial's listing on clinicaltrials.gov, it is currently seeking participants. The research was initially posted on October 5th 2022 and has been modified most recently on October 6th 2022."
Answered by AI
How numerous are the participants in this experiment?
"Affirmative. Clinicaltrials.gov states that this ongoing experiment, first published on October 5th 2022 and updated recently, is currently looking for 120 participants across a single site."
Answered by AI
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