Establishing a Sustainable Diabetes Care Management Program Using Continuous Glucose Monitors and Remote Patient Monitoring for Underserved Populations in Safety Net Clinics

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 Diabetesquestionnaire that asks questions about diabetes related distress.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults 18 years or older with Type 2 diabetes AND

• A1c \> 8%

Locations
United States
Massachusetts
Community Health Center of Franklin County
RECRUITING
Greenfield
Contact Information
Primary
Sushma Reddy, MD
sushreddyendo@yahoo.com
8103859699
Backup
Jill Einstein, MD
jeinstein@mavenproject.org
4157223638
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2026-10
Participants
Target number of participants: 40
Treatments
Other: 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
Related Therapeutic Areas
Sponsors
Collaborators: MAVEN Project, DexCom, Inc., Tidepool
Leads: Diabetes Solutions International

This content was sourced from clinicaltrials.gov