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Diabetes Management Using Continuous Glucose Monitors and Remote Patient Monitoring in Underserved Populations

NCT06939413 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-25

No results posted yet for this study

Summary

The goal of this 52 week prospective study is to learn whether a Diabetes Care Management Program using a continuous glucose monitor (CGM) and remotely monitoring (RPM) glucose readings can help improve glucose levels and diabetes related distress in individuals with uncontrolled type 2 diabetes. The CGM and RPM are used as an adjunct to usual care.

The main questions it aims to answer are:

Does use of CGM \& RPM improve A1c? Does use of CGM \& RPM improve the percent of time spent with glucose levels between 70-180 mg/dl? Does the diabetes care management program improve diabetes related distress?

Participants enrolled in the study will be wearing a CGM. Participants will be able to see the glucose readings from the CGM and see how their glucose level responds to food, physical activity, medications and daily life.

The diabetes primary care team will be remotely monitoring the participant's glucose data from the CGM. They will reach out to the participant to make adjustments in treatment regimen as needed.

Participants will answer a "Problem Areas in Diabetes"questionnaire that asks questions about diabetes related distress.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DEVICE

Continuous glucose monitor (CGM)

The glucose data from the CGM will help participants to understand the effect of lifestyle and medications on their glucose levels. The glucose levels from the CGM will be remotely monitored. Outreach will be made to participants not reaching glycemic goals. Appropriate adjustments in treatment regimen will be made based on the glucose data obtained from CGM and RPM

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Tidepool

    collaborator UNKNOWN

  • MAVEN Project

    collaborator UNKNOWN

  • Diabetes Solutions International

    lead OTHER

Principal Investigators

  • Sushma Reddy, MD · Diabetes Solutions International

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2026-10-31
Completion
2026-10-31
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 NCT06939413 on ClinicalTrials.gov