NCT06830135

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
208

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
10mo left

Started Apr 2025

Typical duration for not_applicable diabetes-mellitus

Status
not yet recruiting

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 Progress57%
Apr 2025Mar 2027

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 11, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

diabetescontinuous glucose monitoringremote patient monitoring

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    90 days

Secondary Outcomes (3)

  • 30 days hospital readmissions

    30 days

  • Overall healthcare utilization

    90 days

  • Acute care visits related to abnormal glucose reading

    30 days

Other Outcomes (3)

  • Percentage of Patients Enrolled in the Program

    2 years

  • Changes in Medical Glucose Readings

    7 day

  • Equity in Program Participation

    2 years

Study Arms (2)

Control Arm -standard of care

NO INTERVENTION

Intervention Arm

EXPERIMENTAL

Continuous glucose monitoring, remote patient monitoring for 90 days

Device: Continues glucose monitoring with remote glucose monitoring for 90 days

Interventions

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Andersen JA, Scoggins D, Michaud T, Wan N, Wen M, Su D. Racial Disparities in Diabetes Management Outcomes: Evidence from a Remote Patient Monitoring Program for Type 2 Diabetic Patients. Telemed J E Health. 2021 Jan;27(1):55-61. doi: 10.1089/tmj.2019.0280. Epub 2020 Apr 17.

    PMID: 32302521BACKGROUND
  • Elsener M, Santana Felipes RC, Sege J, Harmon P, Jafri FN. Telehealth-based transitional care management programme to improve access to care. BMJ Open Qual. 2023 Nov;12(4):e002495. doi: 10.1136/bmjoq-2023-002495.

    PMID: 37940335BACKGROUND
  • Greenwood DA, Young HM, Quinn CC. Telehealth Remote Monitoring Systematic Review: Structured Self-monitoring of Blood Glucose and Impact on A1C. J Diabetes Sci Technol. 2014 Mar;8(2):378-389. doi: 10.1177/1932296813519311. Epub 2014 Feb 21.

    PMID: 24876591BACKGROUND
  • Salehi S, Olyaeemanesh A, Mobinizadeh M, Nasli-Esfahani E, Riazi H. Assessment of remote patient monitoring (RPM) systems for patients with type 2 diabetes: a systematic review and meta-analysis. J Diabetes Metab Disord. 2020 Jan 10;19(1):115-127. doi: 10.1007/s40200-019-00482-3. eCollection 2020 Jun.

    PMID: 32550161BACKGROUND
  • Pal K, Eastwood SV, Michie S, Farmer A, Barnard ML, Peacock R, Wood B, Edwards P, Murray E. Computer-based interventions to improve self-management in adults with type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2014 Jun;37(6):1759-66. doi: 10.2337/dc13-1386.

    PMID: 24855158BACKGROUND
  • Boye KS, Thieu VT, Lage MJ, Miller H, Paczkowski R. The Association Between Sustained HbA1c Control and Long-Term Complications Among Individuals with Type 2 Diabetes: A Retrospective Study. Adv Ther. 2022 May;39(5):2208-2221. doi: 10.1007/s12325-022-02106-4. Epub 2022 Mar 22.

    PMID: 35316502BACKGROUND
  • Steinhubl SR, Muse ED, Topol EJ. The emerging field of mobile health. Sci Transl Med. 2015 Apr 15;7(283):283rv3. doi: 10.1126/scitranslmed.aaa3487.

    PMID: 25877894BACKGROUND
  • Rodriguez-Gutierrez R, Herrin J, Lipska KJ, Montori VM, Shah ND, McCoy RG. Racial and Ethnic Differences in 30-Day Hospital Readmissions Among US Adults With Diabetes. JAMA Netw Open. 2019 Oct 2;2(10):e1913249. doi: 10.1001/jamanetworkopen.2019.13249.

    PMID: 31603490BACKGROUND
  • Soh JGS, Wong WP, Mukhopadhyay A, Quek SC, Tai BC. Predictors of 30-day unplanned hospital readmission among adult patients with diabetes mellitus: a systematic review with meta-analysis. BMJ Open Diabetes Res Care. 2020 Aug;8(1):e001227. doi: 10.1136/bmjdrc-2020-001227.

    PMID: 32784248BACKGROUND
  • Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 2020, p. 12-15

    BACKGROUND
  • U.S. Census Bureau. (2022). How has Westchester County's Racial and Ethnic Populations Changed. USA Facts. https://usafacts.org/data/topics/people-society/population-and-demographics/our-changing-population/state/new-york/county/westchester-county/. Accessed 12/9/2023.

    BACKGROUND
  • Westchester Community Foundation (2018) Health: Diabetes Mortality, by Race/Ethnicity. Westchester Index; An Initiative of Westchester County Foundation. https://westchesterindex.org/health/diabetes-mortality-by-race-ethnicity

    BACKGROUND
  • Smithwick, K. (n.d.). Diabetes Mortality, by race/ethnicity. Westchester Index. Retrieved November 3, 2022, from https://westchesterindex.org/health/diabetes-mortality-by-race-ethnicity.

    BACKGROUND
  • NY DOH, (2018). Percentage of Adults with Diagnosed Diabetes, by county, New York State, BRFSS 2018. New York Health. https://www.health.ny.gov/statistics/prevention/injury_prevention/information_for_action/docs/2021-01_ifa_report.pdf

    BACKGROUND
  • CDC. (n.d.). Diabetes State Burden Toolkit. Center for Disease Control and Prevention. https://nccd.cdc.gov/Toolkit/DiabetesBurden/TotalCost. Accessed 12/8/2023.

    BACKGROUND
  • American Diabetes Association. (2021). The Burden of Diabetes in New York. American Diabetes Association. https://www2.diabetes.org/sites/default/files/2021-11/ADV_2021_State_Fact_sheets_New%20York_rev.pdf

    BACKGROUND
  • CDC. (n.d.). Diabetes Data and Statistics. Center for Disease Control and M/edicine. Diabetes Data and Statistics. CDC. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed 12/7/2023

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Michelle Elsener, MBA, BSN, RN-BC, CPHQ

CONTACT

Katarzyna Zarychta, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share