Clinical trial NCT06830135: Telehealth Approach to Enhancing Glycemic Control
Official title: A Multifaceted Telehealth Approach to Enhancing Glycemic Control and Reducing Readmissions in a Diverse Diabetic Population: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
continuous glucose monitoring
remote patient monitoring
Lead sponsor: White Plains Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 90 days
Secondary outcomes:
measure: 30 days hospital readmissions
timeFrame: 30 days
measure: Overall healthcare utilization
timeFrame: 90 days
measure: Acute care visits related to abnormal glucose reading
timeFrame: 30 days
Other outcomes:
measure: Percentage of Patients Enrolled in the Program
timeFrame: 2 years
measure: Changes in Medical Glucose Readings
timeFrame: 7 day
measure: Equity in Program Participation
timeFrame: 2 years
Locations:
Study officials:
References:
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