Remote Pharmacy Services Plus Continuous Glucose Monitoring in an Underserved Population

University of Illinois

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: CGM plus telehealth; Other: CGM only

Study type: Interventional

Funder types: Other

Identifiers

NCT07587151

2264549 - UICOM Rockford

UIC Diabetes Center Pilot (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to improve T2DM (type 2 diabetes mellitus) management and health outcomes among underserved patients who receive primary care at a federally qualified health center (FQHC) in Winnebago County, Illinois.

Our aim is to assess the feasibility and preliminary effectiveness of a pilot program combining continuous glucose monitoring (CGM) with monthly telehealth appointments to improve diabetes management in FQHC patients who have uncontrolled T2DM (HbA1c >7%).

Researchers will compare those who receive the intervention (usual in-person care + CGM + 2 telehealth visits with a clinical pharmacist and family medicine resident) with those receiving a CGM in additional to usual care (in-person care + CGM).

Participants will have their HbA1c tested and complete surveys to assess diabetes-related distress and diabetes management self-efficacy at baseline and 3 and 6 months from baseline. This will allow the investigators to raise glucose awareness for all participants utilizing CGM technology while simultaneously determining the necessity of more frequent follow-up than the guideline recommended intervals of 3 months for uncontrolled diabetes in an under-resourced population. This will also allow us to evaluate the feasibility of telehealth in delivering more frequent follow-up care to patients with T2DM.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient receiving primary care from the study clinical site
• Uncontrolled T2DM (HbA1c >7%)
• 18 years of age and older

Exclusion criteria

• Patients younger than 18 years of age
• Patients in correctional facilities
• Pregnant or lactating women
• Current Continuous Glucose Monitoring device (CGM) users
• Patients with gestational diabetes mellitus or Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

CGM + telehealth

Experimental group

Description:

In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use and 2 telehealth appointments, 1 month and 2 months from their initial appointment. The telehealth appointments will be conducted by a clinical pharmacist and family medicine resident physician and will be used to discuss CGM outcomes and treatment planning.

Treatment:

Other: CGM plus telehealth

CGM only

Active Comparator group

Description:

In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.

Treatment:

Other: CGM only