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

NCT ID: NCT06939413

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2026-10-31

Brief 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.

Detailed Description

BACKGROUND & RATIONALE:

Medical Alumni Volunteer Expert Network (MAVEN) Project is a nonprofit organization dedicated to addressing social, racial, and economic inequities in the healthcare system through the power of telemedicine. The project recruits an experienced corps of volunteer medical specialists and connects them virtually with primary care providers (PCPs) at community health centers using a digital health platform. The services provided include medical consults, eConsults, mentoring, and Continuing Medical Education (CME) programs.

Patients with diabetes seen in safety net clinics are more complex with a higher incidence of diabetes related complications and other chronic conditions. PCPs are often overwhelmed and frustrated with managing diabetes in these patients, especially with the lack of glucose data. Continuous glucose monitor (CGM) use provides a complete glucose picture leading to appropriate adjustment in treatment regimen. In addition, individuals wearing a CGM are more likely to modify their physical activity and eating habits based on the real time glucose levels from the CGM.

MAVEN Project has been instrumental in enhancing diabetes management and improving patient outcomes in these safety net clinics, where 1 in 3 persons live in poverty and 63% identify as a racial/ethnic minority.

Given our early success, it became quite apparent that there was an opportunity to develop an evidence-based diabetes care management program incorporating CGM and remote patient monitoring (RPM) that would improve diabetes outcomes in the underserved population with a potential for implementation in other safety net clinics across the country. PCPs at front line clinics have access to endocrinology expertise through MAVEN Project. Remote patient monitoring of CGM data is now possible as over 98% of the FQHCs offer telehealth services as compared to 48 % in 2018.

PRIMARY OBJECTIVE:

To determine if a sustainable diabetes care management program incorporating CGM and RPM can improve glucose levels and diabetes related distress in individuals with diabetes seen at safety net clinics.

SECONDARY OBJECTIVE:

To determine if a sustainable diabetes care management program incorporating CGM and RPM can improve clinician and patient satisfaction.

STUDY DESIGN:

This is a single-arm prospective 24-week study with an optional 28 week extension designed to investigate the effect of a sustainable diabetes care management program incorporating CGM and RPM on improving glucose levels, diabetes related distress and patient satisfaction in individuals with diabetes seen at safety net clinics. PCP satisfaction will also be assessed. Patients from a clinic site not involved in the study will be used as case matched controls.

All eligible subjects will start on CGM & RPM. Participants will use "guided experiments "during the first 7 to 10 days to understand the effects of food and physical activity on their glucose levels., Participants will follow up with the diabetes primary care team in 10-14 days to review the glucose data.

It is anticipated that about 20% of participants will require insulin and 80% will be on non-insulin treatment. Participants on insulin will continue real time CGM wear throughout the 52-week study. Participants not on insulin will wear real time CGM for the first 12 weeks and intermittently thereafter. All participants will be educated on the use of CGM to help manage their diabetes.

The RPM dashboard will be reviewed weekly, and outreach made to participants with low time in range 70-180 mg/dl (TIR) or no sensor data. CGM and RPM data will be used to adjust the treatment regimen.

CME will be provided by MAVEN Project on topics that are crucial for the PCPs to effectively manage diabetes. A PCP baseline educational needs assessment will be obtained to help guide the timing and necessity of the various CME sessions. Educational sessions will be provided for ancillary staff.

Endocrinology expertise will be provided through e-consults to MAVEN endocrinologists for specific patient management questions. MAVEN Endocrinologists will provide additional support through biweekly meetings with the clinic diabetes champion and monthly study site meetings.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

The participants will be in the intervention arm for 24 weeks with an optional 28 week extension . The intervention being studied is continuous glucose monitoring (CGM) and remote patient monitoring that is being provided as an adjunct to usual diabetes care

Group Type: OTHER

Continuous glucose monitor (CGM)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults 18 years or older with Type 2 diabetes AND
• A1c > 8%

Exclusion Criteria

• Pregnancy (participant-reported)
• Previous real time CGM use for more than 6 weeks in the last 3 months
• Use of steroids
• Active cancer treatment
• Terminal illness
• Dementia, mental impairment
• Type 1 diabetes
• End stage renal disease, on dialysis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Tidepool

UNKNOWN

Sponsor Role: collaborator

MAVEN Project

UNKNOWN

Sponsor Role: collaborator

Diabetes Solutions International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sushma Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Solutions International

Locations

Community Health Center of Franklin County

Greenfield, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sushma Reddy, MD

Role: CONTACT

sushreddyendo@yahoo.com

8103859699

Jill Einstein, MD

Role: CONTACT

jeinstein@mavenproject.org

4157223638

Facility Contacts

Kelly Henry, RN,CDCES,CPT

Role: primary

kelly.henry@chcfc.org

413-325-8500

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IIS-2024-172

Identifier Type: -

Identifier Source: org_study_id