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Continuous Glucose Monitoring for Type 2 Diabetes
N/A
Recruiting
Led By George King, MD
Research Sponsored by Joslin Diabetes Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chinese Americans 40 years and older who are 1st generation immigrants, currently residing in the US, and clinically diagnosed with T2D
Be older than 18 years old
Must not have
Inability to travel due to frailty or health reasons
Currently undergoing or planning to undergo diathermy or high-frequency heat treatments in whom CGM use may be contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Summary
This trial aims to see if continuous glucose monitors (CGM) are practical and beneficial for Asian Americans with Type 2 Diabetes. The study will compare CGM use with other methods to evaluate health outcomes and quality of life. Researchers will also look at social and community factors affecting CGM use. Continuous glucose monitoring (CGM) technology has become an effective complement to other blood glucose monitoring methods and has been widely applied in clinical practice since its development.
Who is the study for?
This trial is for Chinese Americans, 40 years or older, who are first-generation immigrants with type 2 diabetes and an HbA1c level over 7.5%. Participants must be new to using CGM, own a smartphone, and speak English or Chinese. It's not for pregnant women, prisoners, those with severe illnesses including those on dialysis, learning disabilities or dementia.
What is being tested?
The study compares the effectiveness of continuous glucose monitoring (CGM) versus traditional fingerstick monitoring in managing type 2 diabetes among Asian Americans. It will evaluate usability of CGMs, impact on quality of life and health outcomes like blood sugar and cholesterol levels.
What are the potential side effects?
While this study focuses more on monitoring methods than medications that could cause side effects; potential discomforts may include skin irritation from the CGM device adhesive or pain/discomfort from regular fingersticks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a first-generation Chinese American over 40 with Type 2 Diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot travel because of my health condition.
Select...
I am currently receiving or planning to receive heat treatments that may not allow the use of CGM.
Select...
I have been diagnosed with a cognitive impairment or learning disability.
Select...
I am not fluent in English or Chinese.
Select...
I am critically ill and/or on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diabetes Distress Scale (DDS) change over 6 month study period
EQ-5D-5L change over 6 month study period
Feasibility (CGM device adherence)
+4 moreSecondary study objectives
Blood pressure changes from 0-6 months
Diabetes Knowledge and Behavior change from 0-6 months
Family/social-level factors impacting technological device for care management
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Participants on CGMActive Control1 Intervention
Participants in this group will be offered a CGM device for glucose monitoring, with training and educational materials provided in either English or Chinese, according to the participant's preference.
Group II: Participants on Finger-stick onlyPlacebo Group1 Intervention
Participants in this group continue standard fingerstick self-monitoring of blood glucose (FSGM) as per standard care protocol. They will also receive educational materials provided in either English or Chinese, according to the participant's preference.
Find a Location
Who is running the clinical trial?
Joslin Diabetes CenterLead Sponsor
97 Previous Clinical Trials
26,592 Total Patients Enrolled
George King, MDPrincipal InvestigatorJoslin Diabetes Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot travel because of my health condition.I am a first-generation Chinese American over 40 with Type 2 Diabetes.I am currently receiving or planning to receive heat treatments that may not allow the use of CGM.I have been diagnosed with a cognitive impairment or learning disability.Your average blood sugar level, measured by HbA1c, is higher than 7.5% within 3 months before the study starts.I am not fluent in English or Chinese.People who are in prison or women who are pregnant or planning to become pregnant during the study cannot participate.You do not have access to the internet.You have not used a continuous glucose monitor before.I am critically ill and/or on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Participants on CGM
- Group 2: Participants on Finger-stick only
Awards:
This trial has 0 awards, including: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.
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