Recruiting

DCMPDiabetes Management Program with CGM and Remote Monitoring in Underserved Clinics

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What is being tested

Continuous glucose monitor (CGM)

Device
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorDiabetes Solutions International
Study ContactSushma Reddy, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 18, 2025

Actual date on which the first participant was enrolled.

This study aims to develop a program to better manage diabetes in underserved communities by using technology, specifically continuous glucose monitors (CGM) and remote patient monitoring (RPM). These tools help provide a clearer picture of blood sugar levels, which is crucial for adjusting treatment plans. The study focuses on people visiting safety net clinics, often experiencing higher rates of diabetes complications. The goal is to improve glucose control and reduce stress related to diabetes, ultimately enhancing both patient and healthcare provider satisfaction. With more clinics offering telehealth services, this program has the potential to be used more widely, benefiting many people who might otherwise struggle to manage their diabetes effectively. Participants in the study will use CGMs to track their blood sugar continuously. They will also take part in experiments to see how food and exercise affect their glucose levels. Follow-ups with their healthcare team are scheduled to review this data and adjust treatments if necessary. Those needing insulin will wear the CGM throughout the study, while others will use it for the first 12 weeks and then intermittently. The study includes weekly monitoring of the RPM dashboard to ensure participants maintain their glucose levels within a healthy range. Educational support for both patients and healthcare providers is part of the program, with ongoing advice from endocrinology experts available to assist the primary care providers. This integrated approach aims to empower patients and healthcare providers, making diabetes management more effective and less stressful.

Official TitleEstablishing a Sustainable Diabetes Care Management Program Using Continuous Glucose Monitors and Remote Patient Monitoring for Underserved Populations in Safety Net Clinics
NCT06939413
Principal SponsorDiabetes Solutions International
Study ContactSushma Reddy, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Adults 18 years or older with Type 2 diabetes AND

A1c > 8%

8 exclusion criteria prevent from participating
Terminal illness

Pregnancy (participant-reported)

Previous real time CGM use for more than 6 weeks in the last 3 months

Use of steroids

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Community Health Center of Franklin County

Greenfield, United StatesOpen Community Health Center of Franklin County in Google Maps
Recruiting
One Study Center