Clinical trial NCT06939413: Diabetes Management Using Continuous Glucose Monitors and Remote Patient Monitoring in Underserved Populations
Official title: Establishing a Sustainable Diabetes Care Management Program Using Continuous Glucose Monitors and Remote Patient Monitoring for Underserved Populations in Safety Net Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Uncontrolled type 2 diabetes mellitus
CGM
Remote patient monitoring
Lead sponsor: Diabetes Solutions International
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
name: Tidepool
name: MAVEN Project
First posted: 2025-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm prospective 24-week study with an optional 28 week extension Patients from a clinic site not involved in the study will be used as case matched controls.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in A1c
timeFrame: Baseline, 12, 24, 36 and 52 weeks
measure: Change in time in range (TIR)
timeFrame: Baseline, 6, 12, 24, 36 and 52 weeks
measure: Change in Problem Areas in Diabetes (PAID) score
timeFrame: Baseline, 12, 24 and 52 weeks
Secondary outcomes:
measure: Change in time above range (TAR)
timeFrame: Assessed at baseline, 6, 12, 24, 36 and 52 weeks
measure: Change in time below range (TBR)
timeFrame: Assessed at baseline, 6, 12, 24, 36 and 52 weeks
measure: Change in Glucose Management Indicator (GMI)
timeFrame: Assessed at baseline, 6, 12, 24, 36 and 52 weeks
measure: Patient Satisfaction Survey
timeFrame: Assessed at 12, 24 and 52 weeks
measure: Change in Primary care provider (PCP) Satisfaction
timeFrame: Assessed at baseline , 24 and 52 weeks
Other outcomes:
Locations:
city: Greenfield
country: United States
facility: Community Health Center of Franklin County
state: Massachusetts
Study officials:
affiliation: Diabetes Solutions International
name: Sushma Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: