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

Part of paid clinical trials in Greenfield, Massachusetts.

Sponsor
Diabetes Solutions International
Study ID
NCT06939413
Status
Recruiting
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Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous glucose monitor (CGM) — 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

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Apr 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in A1c [ Time Frame: Baseline, 12, 24, 36 and 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Community Health Center of Franklin CountyGreenfieldMassachusetts01301
Kelly Henry, RN,CDCES,CPT
[email protected]
413-325-8500

Find similar trials in Greenfield, MA

By research site
Community Health Center of Franklin County· Greenfield, MA

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