Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Virtual Environment, Self-Management
Brief summary
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.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Intake | 18 months | Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months |
| Change in Physical Activity | 18 months | Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1C level | 18 months | Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months |
| Change in BMI | 18 months | BMI will measured at the start of study and at 6, 12, and 18 months. |
| Change in Lipid Levels | 18 months | 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. |
| Change in Blood Pressure | 18 months | Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months. |
| Change in Waist Circumference | 18 months | Waist circumference will be measured at start of study and at 6, 12, and 18 months. |
Countries
United States
Outcome results
None listed