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

NCT05826678 | Recruiting FDA Device

• 1 other identifier: STUDY00000206
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Check if continuous glucose monitoring is doable and consistent for this group, and see how it affects their quality of life.
2. 2.Estimate how well the health outcomes (glucose and lipid markers) vary over the study period.
3. 3.Understand how social and community factors can impact the use of continuous glucose monitors in this group.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuous Glucose Monitoring; Health Disparity

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (7)

• HbA1c change (%) from 0-6 months

  Change in measure comparing Baseline and 6 months

• Time in range (TIR) metrics change (%) from 0-6 months

  Change in measure comparing Baseline and 6 months

• Lipid changes from 0-6 months

  Change in measure comparing Baseline and 6 months

• Blood pressure changes from 0-6 months

  Change in measure comparing Baseline and 6 months

• eGFR changes from 0-6 months

  Change in measure comparing Baseline and 6 months

Study Arms (2)

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.

Device: Continuous Glucose Monitor

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.

Behavioral: Finger stick glucose monitoring

Interventions

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.

Participants on CGM

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.

Participants on Finger-stick only

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Joslin Diabetes Center: lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• George King, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: September 22, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)