Telehealth Approach to Enhancing Glycemic Control

February 14, 2025 updated by: White Plains Hospital

A Multifaceted Telehealth Approach to Enhancing Glycemic Control and Reducing Readmissions in a Diverse Diabetic Population: A Randomized Control Trial

This study evaluates whether the use of a Continuous Glucose Monitoring (CGM) device combined with a Remote Patient Monitoring (RPM) program can improve blood sugar control and reduce hospital visits among patients with poorly controlled diabetes who have recently been discharged from the hospital.

The study, led by White Plains Hospital (WPH) Cares, will follow 208 patients for 90 days after their discharge. Half of the participants will receive standard care, while the other half will receive a Dexcom G7 CGM device along with support from trained nurses who will monitor their glucose readings daily. The goal is to determine whether this approach helps lower Hemoglobin A1c (HbA1c) levels, reduces hospital readmissions, and improves overall health outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Discharged Home from the WPH Inpatient Setting A1c >= 8.0 within 90 days of discharge >= 18 Years of Age Lives within Westchester County

Exclusion Criteria:

  • <18 Years of Age Patient With Documented Cognitive Impairment or Decisional Incapacity Pregnant or Plans to Become Pregnant in 6 Months Discharge Disposition of Short-term or Long-term Care Facility, Assisted Living Facility, Group Home, Against Medical Advice/Eloped, or Home Hospice Patient or Caregiver Unable to Check Glucose at Home Using a Home Glucometer Lives Outside Westchester County

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm -standard of care
Experimental: Intervention Arm
Continuous glucose monitoring, remote patient monitoring for 90 days
Device: Continues glucose monitoring with remote glucose monitoring for 90 days
CGM + RPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
30 days hospital readmissions
Time Frame: 30 days
30 days
Overall healthcare utilization
Time Frame: 90 days
90 days
Acute care visits related to abnormal glucose reading
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Enrolled in the Program
Time Frame: 2 years
2 years
Changes in Medical Glucose Readings
Time Frame: 7 day
7 day
Equity in Program Participation
Time Frame: 2 years
(% of Participants Who Are Hispanic, African American, or Uninsured)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

White Plains Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WPH IRB: 2025-16585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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