RecruitingNot ApplicableNCT06939413

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

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

Sponsor

Diabetes Solutions International

Enrollment

40 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a continuous glucose monitor (CGM) — a small wearable device that tracks blood sugar levels around the clock — along with remote patient monitoring can help improve diabetes management in underserved communities. The focus is on adults with type 2 diabetes whose blood sugar is not well controlled. **You may be eligible if...** - You are 18 or older - You have type 2 diabetes - Your HbA1c (a measure of average blood sugar over 3 months) is above 8% **You may NOT be eligible if...** - You are pregnant - You have used a real-time continuous glucose monitor for more than 6 weeks in the last 3 months - You are currently on steroid medications - You are undergoing active cancer treatment - You have a terminal illness or dementia - You have type 1 diabetes - You are on dialysis for end-stage kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous 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