Recruiting

Continuous Glucose Monitoring

Sponsor:

Joslin Diabetes Center

Code:

NCT05826678

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor

Finger stick glucose monitoring

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT05826678

Start date

Sep 22, 2022

Status verified date

Mar, 2024

Completion date

May 31, 2024

Anticipated

Primary completion date

May 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: 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.

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.

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.

Primary outcome measure

  • Feasibility (CGM device adherence) [ Time Frame: 6 month ]
  • Feasibility (Consistency) 1 [ Time Frame: 6 months ]
  • Feasibility (Consistency) 2 [ Time Frame: 6 months ]
  • World Health Organization (Five) Well-Being Index (WHO-5) change over 6 month study period [ Time Frame: Change in measure comparing Baseline and 6 months ]
  • EQ-5D-5L change over 6 month study period [ Time Frame: Change in measure comparing Baseline and 6 months ]
  • Diabetes Distress Scale (DDS) change over 6 month study period [ Time Frame: Change in measure comparing Baseline and 6 months ]
  • Hypoglycemic Confidence Scale (HCS) change over 6 month study period [ Time Frame: Change in measure comparing Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Hetal Shah, MD, MPH

617-309-4343hetal.shah@joslin.harvard.edu

Atif Adam, PhD, MD, MPH

4103363626atif.adam@joslin.harvard.edu

Locations

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Hetal Shah, MD, MPH

617-309-4343hetal.shah@joslin.harvard.edu

Principal Investigator:

George King, MD

More Information

Sponsor

Joslin Diabetes Center

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

  • Continuous Glucose Monitoring
  • Health Disparity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joslin Diabetes Center on 2024-03-15.