Diabetes Self-Management & Support LIVE

Study Overview
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Brief Summary
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The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.

Official Title
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Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: LIVE
* Behavioral: Website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow-up research appointments Diagnosis of Type 2 Diabetes (T2D) >= 21 years old able to read and understand English access to a computer with broad band internet connection in a private location reachable by telephone no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g. Are able to travel to a clinical lab for blood work Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 21 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIVE Arm<br>Participation in 3D virtual environment for DSMT/S for a period of 12 months. | Behavioral: LIVE<br>* 3-D Virtual Environment for DSMT/S<br>|
| Active Comparator: Website<br>Participation in 2D website for DSMT/S for a period of 12 months. | Behavioral: Website<br>* 2-D Website participation for DSMT/S<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dietary Intake | Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months | 18 months | 
| Change in Physical Activity | Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C level | Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months | 18 months | 
| Change in BMI | BMI will measured at the start of study and at 6, 12, and 18 months. | 18 months | 
| Change in Waist Circumference | Waist circumference will be measured at start of study and at 6, 12, and 18 months. | 18 months | 
| Change in Blood Pressure | Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months. | 18 months | 
| Change in Lipid Levels | High density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol (TC) and triglyceride levels will be measured at the start of the study and again at 6, 12 and 18 months. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Virtual Environment, Self-Management