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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 below

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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:

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I cannot travel because of my health condition.

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I am currently receiving or planning to receive heat treatments that may not allow the use of CGM.

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I have been diagnosed with a cognitive impairment or learning disability.

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I am not fluent in English or Chinese.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

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 more

Secondary 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 more

Trial 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.

0 / 6Eligibility criteria met