Telehealth Approach to Enhancing Glycemic Control

NCT ID: NCT06830135

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Arm -standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Continuous glucose monitoring, remote patient monitoring for 90 days

Group Type EXPERIMENTAL

Continues glucose monitoring with remote glucose monitoring for 90 days

Intervention Type DEVICE

CGM + RPM

Interventions

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Continues glucose monitoring with remote glucose monitoring for 90 days

CGM + RPM

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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White Plains Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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

Role: CONTACT

914-849-2273

Katarzyna Zarychta, MS

Role: CONTACT

914-849-7429

References

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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.

Reference Type BACKGROUND
PMID: 32302521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37940335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24876591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32550161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24855158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35316502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25877894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31603490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32784248 (View on PubMed)

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

Reference Type 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.

Reference Type 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

Reference Type 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.

Reference Type 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

Reference Type 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.

Reference Type 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

Reference Type 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

Reference Type BACKGROUND

Other Identifiers

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WPH IRB: 2025-16585

Identifier Type: -

Identifier Source: org_study_id

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