NCT07587151

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

diabetescontinuous glucose monitortelehealthfederally qualified health center

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

EXPERIMENTAL

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.

Other: CGM plus telehealth

CGM only

ACTIVE COMPARATOR

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

Other: CGM only

Interventions

Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.

CGM + telehealth

Participants will receive CGM supplies for 3 months

CGM only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 22100963BACKGROUND
  • 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.

    PMID: 39010293BACKGROUND
  • 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.

    PMID: 37987208BACKGROUND
  • 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.

    PMID: 39576644BACKGROUND
  • 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.

    PMID: 32865027BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Continuous Glucose MonitoringTelemedicine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative TechniquesDelivery of Health CarePatient Care ManagementHealth Services Administration

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

Locations