Diabetes Management Program for Hispanic/Latino

To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Diabetes Telemonitoring; Other: Comprehensive Outpatient Management

Detailed Description

The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:

Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.

Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Feinstein Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hispanic patients with a diagnosis of diabetes
• Speaks English or Spanish

Exclusion Criteria:

• Patient is not Hispanic
• Patient does not have a diagnosis of diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes Telemonitoring (DTM); Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for Type 2 Diabetes (T2D), uses smart devices to share information between patients, caregivers, and clinicians. DTM includes:1) weekly real time "virtual" visit between patient and clinician 2) vital signs monitoring/interpretation 3) diabetes management 4) patient interactive educational videos and "teach back" quizzes, reinforcing self-management strategies 5) a caregiver app with supportive capability.	Behavioral: Diabetes Telemonitoring; Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.; Other Names: DTM
Active Comparator: Comprehensive Outpatient Management (COM); Comprehensive Outpatient Management (COM) is the most realistic evidence-based comparator, in that it is the most frequently recommended and used option for US T2D patients. COM, like DTM, is consistent with the 2018 American Diabetes Association (ADA) Standards which include, but are not limited to, past medical and family history, social history, medications, screening, physical examination, laboratory evaluation, etc.Patients are instructed to monitor blood glucose (within physician recommendations), and have routine or "well" visits every 3 months. Patients can set appointments with a T2D educator. COM patients will receive monthly calls from the study Registered Nurse (RN) to collect data.	Other: Comprehensive Outpatient Management; Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.; Other Names: COM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	HbA1c	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Hemoglobin A1c	12 months
Hypoglycemia episodes	Number of hypoglycemia episodes	6 months
Adherence	Adherence to Refills and Medications - Diabetes (ARMS-D)	6 months
Diabetes self-efficacy	Diabetes Self-Efficacy Scale	6 months
PAID	Problem Areas in Diabetes Scale	6 months
Weight	lbs	6 months
Cholesterol	Changes in cholesterol over time	6 months
Blood Pressure	BP	6 months
Diabetes Quality of life	Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients	6 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Renee Pekmezaris, PhD, Feinstein Institute for Medical Research

Publications and helpful links

General Publications

• Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): March 12, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19-0002

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