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OpenTrials
Completed

NCT Number: NCT03960424

Diabetes Management Program for Hispanic/Latino

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feinstein Institute of Medical Research

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Outpatient Management

Other

Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.

Other names: COM

Diabetes Telemonitoring

Behavioral

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

Primary outcomes

  1. Hemoglobin A1C

    Time frame: 6 months

    HbA1c

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    Hemoglobin A1c

  2. Hypoglycemia episodes

    Time frame: 6 months

    Number of hypoglycemia episodes

  3. Adherence

    Time frame: 6 months

    Adherence to Refills and Medications - Diabetes (ARMS-D)

  4. Diabetes self-efficacy

    Time frame: 6 months

    Diabetes Self-Efficacy Scale

  5. PAID

    Time frame: 6 months

    Problem Areas in Diabetes Scale

  6. Weight

    Time frame: 6 months

    lbs

  7. Cholesterol

    Time frame: 6 months

    Changes in cholesterol over time

  8. Blood Pressure

    Time frame: 6 months

    BP

  9. Diabetes Quality of life

    Time frame: 6 months

    Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 23, 2019
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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