Type 2 Diabetes, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
OTHERComprehensive Outpatient Management
Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
BEHAVIORALDiabetes Telemonitoring
Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.
Sponsors
Patient-Centered Outcomes Research Institute
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mixed Methods Design, incorporating adaptations before RCT trial commencement.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 6 months | HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia episodes | 6 months | Number of hypoglycemia episodes |
| Adherence | 6 months | Adherence to Refills and Medications - Diabetes (ARMS-D) |
| Diabetes self-efficacy | 6 months | Diabetes Self-Efficacy Scale |
| PAID | 6 months | Problem Areas in Diabetes Scale |
| HbA1c | 12 months | Hemoglobin A1c |
| Cholesterol | 6 months | Changes in cholesterol over time |
| Blood Pressure | 6 months | BP |
| Diabetes Quality of life | 6 months | Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients |
| Weight | 6 months | lbs |
Countries
United States
Outcome results
None listed