Remote Pharmacy Services Plus Continuous Glucose Monitoring in an Underserved Population
The Role of Remote Pharmacy Services With Continuous Glucose Monitoring in an Underserved Population
2 other identifiers
interventional
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2026
CompletedFirst Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedMay 14, 2026
May 1, 2026
8 months
May 8, 2026
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
Hemoglobin A1c
Enrollment, 3 months, and 6 months
Secondary Outcomes (2)
Diabetes-related distress
Enrollment, 3 months, and 6 months
Diabetes Management Self-Efficacy
Baseline, 3 months, and 6 months
Study Arms (2)
CGM + telehealth
EXPERIMENTALIn 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.
CGM only
ACTIVE COMPARATORIn addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.
Interventions
Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.
Eligibility Criteria
You may qualify if:
- Patient receiving primary care from the study clinical site
- Uncontrolled T2DM (HbA1c \>7%)
- years of age and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois College of Medicine Rockford
Rockford, Illinois, 61107, United States
Related Publications (5)
Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.
PMID: 22100963BACKGROUNDPatel PM, Thomas D, Liu Z, Aldrich-Renner S, Clemons M, Patel BV. Systematic review of disparities in continuous glucose monitoring and insulin pump utilization in the United States: Key themes and evidentiary gaps. Diabetes Obes Metab. 2024 Oct;26(10):4293-4301. doi: 10.1111/dom.15774. Epub 2024 Jul 15.
PMID: 39010293BACKGROUNDUhl S, Choure A, Rouse B, Loblack A, Reaven P. Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Clin Endocrinol Metab. 2024 Mar 15;109(4):1119-1131. doi: 10.1210/clinem/dgad652.
PMID: 37987208BACKGROUNDWallia A, Agarwal S, Owen AL, Lam EL, Davis K, Bailey SC, DeLacey SE, Pack AP, Espinoza J, Bright D, Eggleston A, Walter E, O'Brien MJ. Disparities in Continuous Glucose Monitoring Among Patients Receiving Care in Federally Qualified Health Centers. JAMA Netw Open. 2024 Nov 4;7(11):e2445316. doi: 10.1001/jamanetworkopen.2024.45316.
PMID: 39576644BACKGROUNDMyers A, Presswala L, Bissoonauth A, Gulati N, Zhang M, Izard S, Kozikowski A, Meyers K, Pekmezaris R. Telemedicine for Disparity Patients With Diabetes: The Feasibility of Utilizing Telehealth in the Management of Uncontrolled Type 2 Diabetes in Black and Hispanic Disparity Patients; A Pilot Study. J Diabetes Sci Technol. 2021 Sep;15(5):1034-1041. doi: 10.1177/1932296820951784. Epub 2020 Aug 29.
PMID: 32865027BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 14, 2026
Study Start
March 31, 2025
Primary Completion
December 5, 2025
Study Completion
April 28, 2026
Last Updated
May 14, 2026
Record last verified: 2026-05