Trial to Assess Continuous Glucose Monitoring in Asian Americans With Type 2 Diabetes

NCT ID: NCT05826678

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2024-05-31

Brief Summary

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:

1. Check if continuous glucose monitoring is doable and consistent for this group, and see how it affects their quality of life.

2. Estimate how well the health outcomes (glucose and lipid markers) vary over the study period.

3. Understand how social and community factors can impact the use of continuous glucose monitors in this group.

Detailed Description

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:

1. Higher unawareness rate: A major contributor to higher T2D unawareness among AAs is the significant difference in BMI-associated T2D risk among AAs (24-25 kg/m2) compared with non-Asians (29-30 kg/m2). Until the "Screen at 23" campaign (See "Innovation"), no national agency would recognize and recommend that AAs be screened for T2D at lower BMIs of 23-25 kg/m2. Furthermore, NHANES data has shown that while age- and sex-adjusted diabetes prevalence among AAs is 19%, the breakdown of this figure may not be truly reflective of the actual prevalence among the disaggregated AA subgroups, which showed a wide variation with South Asians at 23%, Southeast Asians at 22%, and East Asians (including Chinese, Koreans and Japanese) at 14%, the last one being comparable to a recent report from China which showed diabetes prevalence of 11.2%.

2. Cultural and language barriers: AAs living in the US have the highest rates (35%) of limited English proficiency. This figure is even higher at 44% for foreign-born ChA. Limited English proficiency is closely linked to reduced health access, poor health outcomes and lower utilization rates of health technologies.

3. Model minority myth: Hurdles to health care have been significantly exacerbated by the exponential rise in anti-Asian sentiments during the COVID-19 pandemic.

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:

1. Evaluate feasibility (adherence and consistency) and quality of life measures during CGM use in this population.

2. Generate precision estimates of the distribution of the secondary outcomes (6-month glycemic control and lipid markers) in both arms to inform a future randomized controlled trial (RCT).

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Participants on CGM

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 Type: ACTIVE_COMPARATOR

Continuous Glucose Monitor

Intervention Type: 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.

Participants on Finger-stick only

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.

Group Type: PLACEBO_COMPARATOR

Finger stick glucose monitoring

Intervention Type: 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.

Interventions

Continuous Glucose Monitor

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.

Intervention Type: DEVICE

Finger stick glucose monitoring

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Chinese Americans 40 years and older who are 1st generation immigrants, currently residing in the US, and clinically diagnosed with T2D.
• CGM-naïve
• HbA1c >7.5% within 3 months of study commencement.
• Participants should also possess a smartphone, as this is needed in order to facilitate the collection of CGM data by the study team as well as homogenize CGM usage education.

Exclusion Criteria

• Known diagnosis of dysfunction/dementia or learning disabilities
• Not fluent in either English or Chinese
• Currently undergoing or planning to undergo diathermy or high-frequency heat treatments in whom CGM use may be contraindicated
• Inability to travel due to frailty or health reasons
• Lack of internet access
• Critically ill populations, including those on dialysis
• Vulnerable populations (prisoners and women who are pregnant or planning to be pregnant during the time of study)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George King, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hetal Shah, MD, MPH

Role: CONTACT

hetal.shah@joslin.harvard.edu

617-309-4343

Atif Adam, PhD, MD, MPH

Role: CONTACT

atif.adam@joslin.harvard.edu

4103363626

Facility Contacts

Hetal Shah, MD, MPH

Role: primary

hetal.shah@joslin.harvard.edu

617-309-4343

Other Identifiers

STUDY00000206

Identifier Type: -

Identifier Source: org_study_id