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

NCT05826678 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • George King, MD · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2024-05-15
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826678 on ClinicalTrials.gov