- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07587151
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Rockford, Illinois, United States, 61107
- University of Illinois College of Medicine Rockford
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CGM + telehealth
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.
|
Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.
|
|
Active Comparator: CGM only
In addition to usual care for patients with poorly controlled diabetes, participants will receive a CGM plus education on its use.
|
Participants will receive CGM supplies for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: Enrollment, 3 months, and 6 months
|
Hemoglobin A1c
|
Enrollment, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes-related distress
Time Frame: Enrollment, 3 months, and 6 months
|
Diabetes-related distress as assessed by the TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM (T2-DDAS)
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Enrollment, 3 months, and 6 months
|
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Diabetes Management Self-Efficacy
Time Frame: Baseline, 3 months, and 6 months
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Diabetes management self-efficacy as assessed by the Stanford English Diabetes Self-Management study diabetes self-efficacy questionnaire. Stanford English Diabetes Self-Management study. Study reported in Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-Management: A Randomized Trial. The Diabetes Educator 2009; Jul-Aug;35(4):641-51. |
Baseline, 3 months, and 6 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Patel 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.
- Uhl 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.
- Wallia 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.
- Myers 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Health Services Administration
- Delivery of Health Care
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Patient Care Management
- Blood Chemical Analysis
- Clinical Chemistry Tests
- Diagnostic Techniques, Endocrine
- Monitoring, Physiologic
- Telemedicine
- Continuous Glucose Monitoring
Other Study ID Numbers
- 2264549 - UICOM Rockford
- UIC Diabetes Center Pilot (Other Identifier: UIC Diabetes Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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