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This study aims to understand the use of continuous glucose monitors (CGM) in Asian Americans with type 2 diabetes (T2D). Researchers will compare participants on continuous glucose monitors with participants using fingerstick self-monitoring with the aim of answering the following questions:
The Type 2 Diabetes (T2D) pandemic continues to expand in the U.S. and globally. However, the prevalence of T2D is much higher in Asian-Americans (AA) and in other minorities compared to non-Hispanic Whites in the U.S, and AAs have the highest age- and sex-adjusted undiagnosed rate of T2D (7.5%) compared to all other ethnic and racial groups. There is ample evidence that disparities in diagnosis and care for T2D exist in AA communities. The majority of AAs are 1st generation immigrants, and this has further contributed to the disparity in care and diagnosis of diabetes due to the following reasons:
Rapidly advancing diabetes technologies, especially CGM, can achieve better metabolic targets, lower diabetes-related complications, and provide a better quality of life, which have been reported for other ethnic groups but not for AAs due to the systemic exclusion of AAs from CGM studies. Multiple systemic barriers exist for AA to access CGMs, including costs and lack of data to justify reimbursement, provider inertia, and lack of advocacy and vocalization of needs, on top of limited English proficiency and lack of culturally-tailored education. These barriers are in addition to a lack of "Digital Literacy", the new "super social determinant of health", which will increase disparities between those who have skills and access to digital tools and those who do not. In this proposal, we will evaluate the impact, barriers and facilitators of CGM use and adherence in AAs (1st generation ChA) with T2D.
In this 6-month clinical trial, we will examine the impact of CGM use vs. No CGM among 1st generation ChA with T2D.The aim will be to:
3: Identify multi-level barriers and facilitators of CGM use for ChA with T2D, using a socioecological framework (patient-level, provider-level, and community/environment level). We aim to comprehensively evaluate the implementation process (facilitators and impediments), resource requirements, and intermediate patient adherence outcomes for the program using mixed-methods approaches. These will inform the design of culturally-tailored interventions for larger RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants on CGM | Active Comparator | 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. |
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| Participants on Finger-stick only | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | The Clinical Diabetes Educator (CDE) will follow up with the participants at Month 1 after the baseline study visit, at the study midpoint (Month 3), and at the end of the study (Month 6) to check CGM usage, including timely calibration and change adherence. At the end of the study, participants will be invited to complete a survey and participate in virtual interviews to assess changes in their health behaviors and the acceptability of CGM devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (CGM device adherence) | Number of hours device is active in total for the entire 6 month study period | 6 month |
| Feasibility (Consistency) 1 | Proportion CGM program elements completed at each visit against a checklist of pre-specified essential elements | 6 months |
| Feasibility (Consistency) 2 | Average session duration as compared to assigned time plan. | 6 months |
| World Health Organization (Five) Well-Being Index (WHO-5) change over 6 month study period | WHO-5 uses a five-item scale to assess overall well-being | Change in measure comparing Baseline and 6 months |
| EQ-5D-5L change over 6 month study period | EQ-5D-5L assesses health status both as an overall self-rated health on a visual analog scale and across five areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity (no/mild, moderate, or severe problems) | Change in measure comparing Baseline and 6 months |
| Diabetes Distress Scale (DDS) change over 6 month study period | DDS is a 17-item scale that measures worry and concerns specifically related to diabetes and its management | Change in measure comparing Baseline and 6 months |
| Hypoglycemic Confidence Scale (HCS) change over 6 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change (%) from 0-6 months | HbA1c change (%) between baseline (0 months) and end of intervention period (6 months) will be assessed as a continuous response variable for each study arm | Change in measure comparing Baseline and 6 months |
| Time in range (TIR) metrics change (%) from 0-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hetal Shah, MD, MPH | Contact | 617-309-4343 | hetal.shah@joslin.harvard.edu | |
| Atif Adam, PhD, MD, MPH | Contact | 4103363626 | atif.adam@joslin.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| George King, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Finger stick glucose monitoring | Behavioral | Participants will adhere to the standard care protocol and continue self-monitoring of blood glucose through fingersticks as per usual practice[46]. The Clinical Diabetes Educator (CDE) will monitor and provide follow-up to the control group participants as per the same schedule followed for the intervention group. |
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HCS is a nine-item survey that evaluates the degree to which patients feel able, secure, and comfortable about their ability to stay safe from hypoglycemic-related problems
| Change in measure comparing Baseline and 6 months |
Change in %TIR metrics between baseline (0 months) and end of intervention period (6 months) will be assessed as a continuous response variable for the CGM+ arm |
| Change in measure comparing Baseline and 6 months |
| Lipid changes from 0-6 months | We plan to assess the changes from baseline to 6 months for levels of lipid profile components, including total cholesterol, triglyceride, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) levels. | Change in measure comparing Baseline and 6 months |
| Blood pressure changes from 0-6 months | We will assess change from baseline to 6 months for systolic and diastolic blood pressures. | Change in measure comparing Baseline and 6 months |
| eGFR changes from 0-6 months | We will assess change from baseline to 6 months for eGFR | Change in measure comparing Baseline and 6 months |
| Diabetes Knowledge and Behavior change from 0-6 months | Assessed through Semi-structured virtual interviews that will be conducted at the Baseline and 6-month mark. | Change comparing Baseline and 6 months |
| Family/social-level factors impacting technological device for care management | Semi-structured virtual interviews conducted at baseline and 6-month mark (in both arms) will also probe participants on broad topics of stigmas related to technology will be assessed with more directed questions on stigmas in varying environments-home, work, and in social gatherings. | Change comparing Baseline and 6 months |
| D004700 | Endocrine System Diseases |