Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2 diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.

Detailed Description
-----------------
In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.

Official Title
-----------------
The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Virtual Diabetes Self-Care and Education Program
* Device: Fitbit
* Device: Smartphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have physician-diagnosed type 2 diabetes Be self-identified as Hispanic or Latino An A1c value between 8-14% within the last three months. Demonstrate the ability, either alone or with the help of a family member that will be with the patient at least once a week, to use the technology that will be used during the teleconsultations Exclusion Criteria: Severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc. Concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc. Any other condition that would affect participant's basic mental health skills Type 1 diabetes or gestational diabetes Patients with abnormal hemoglobin, anemia or any condition that may affect red blood cell turnover. Any of these conditions may be detected through participants' history or through the laboratory report at study screening Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care. | |
| Experimental: Intervention<br>Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months. | Behavioral: Virtual Diabetes Self-Care and Education Program<br>* Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.<br>Device: Fitbit<br>* Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.<br>* Other names: physical activity tracker;Device: Smartphone<br>* All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, Telehealth, Hispanics, Latinos, Self-Care, Mobile Health, mHealth