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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Telemonitoring (DTM) | Experimental | 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. |
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| Comprehensive Outpatient Management (COM) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Outpatient Management | Other | Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | HbA1c | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Hemoglobin A1c | 12 months |
| Hypoglycemia episodes | Number of hypoglycemia episodes | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Pekmezaris, PhD | Feinstein Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute of Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33287815 | Derived | Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2024 | |
| Reset | Jul 18, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2020 | Sep 7, 2020 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2020 | Sep 7, 2020 | ICF_005.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2024 | Jul 18, 2024 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Mixed Methods Design, incorporating adaptations before RCT trial commencement.
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| 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. |
|
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| 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 |
| D004700 | Endocrine System Diseases |