Diabetes Management Program for Hispanic/Latino

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus

• Registration Number: NCT03960424
• Lead Sponsor: Northwell Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-23
• Study Start: 2019-09-30
• Primary Completion: 2023-03-12
• Study Completion: 2023-09-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	6 months	HbA1c

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Feinstein Institute of Medical Research; 🇺🇸 Manhasset, New York, United States