NCT03960424

Diabetes Management Program for Hispanic/Latino

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Comprehensive Outpatient Management	Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-03-12
• Completion: 2023-09-08
• First posted: 2019-05-23
• Last updated: 2023-10-16

Locations

1 site across 1 country: United States