Diabetes Management Program for Hispanic/Latino

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

Detailed Description
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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.

Official Title
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Diabetes Management Program for Hispanic/Latino

Conditions
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Type 2 Diabetes Mellitus, Type 2 Diabetes

Intervention / Treatment
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* Other: Comprehensive Outpatient Management
* Behavioral: Diabetes Telemonitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Mixed Methods Design, incorporating adaptations before RCT trial commencement.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Telemonitoring (DTM)<br>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<br>* Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.<br>* Other names: DTM;|
| Active Comparator: Comprehensive Outpatient Management (COM)<br>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<br>* Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.<br>* Other names: COM;|

What is the study measuring?
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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 |