Clinical trial NCT05826678: Trial to Assess Continuous Glucose Monitoring in Asian Americans With Type 2 Diabetes
Official title: A Pilot Clinical Trial to Assess Feasibility, Facilitators and Barriers of Continuous Glucose Monitoring in Asian Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Continuous Glucose Monitoring
Health Disparity
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Feasibility (CGM device adherence)
timeFrame: 6 month
measure: Feasibility (Consistency) 1
timeFrame: 6 months
measure: Feasibility (Consistency) 2
timeFrame: 6 months
measure: World Health Organization (Five) Well-Being Index (WHO-5) change over 6 month study period
timeFrame: Change in measure comparing Baseline and 6 months
measure: EQ-5D-5L change over 6 month study period
timeFrame: Change in measure comparing Baseline and 6 months
measure: Diabetes Distress Scale (DDS) change over 6 month study period
timeFrame: Change in measure comparing Baseline and 6 months
measure: Hypoglycemic Confidence Scale (HCS) change over 6 month study period
timeFrame: Change in measure comparing Baseline and 6 months
Secondary outcomes:
measure: HbA1c change (%) from 0-6 months
timeFrame: Change in measure comparing Baseline and 6 months
measure: Time in range (TIR) metrics change (%) from 0-6 months
timeFrame: Change in measure comparing Baseline and 6 months
measure: Lipid changes from 0-6 months
timeFrame: Change in measure comparing Baseline and 6 months
measure: Blood pressure changes from 0-6 months
timeFrame: Change in measure comparing Baseline and 6 months
measure: eGFR changes from 0-6 months
timeFrame: Change in measure comparing Baseline and 6 months
measure: Diabetes Knowledge and Behavior change from 0-6 months
timeFrame: Change comparing Baseline and 6 months
measure: Family/social-level factors impacting technological device for care management
timeFrame: Change comparing Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: George King, MD
role: PRINCIPAL_INVESTIGATOR
References: