An interventional study of LIVE and Website in Diabetes Mellitus, Type 2, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Duke University · Not applicable, Interventional, and Other
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.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 212 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
Behavioral: LIVE
Participation in 2D website for DSMT/S for a period of 12 months.
Behavioral: Website
3-D Virtual Environment for DSMT/S
2-D Website participation for DSMT/S
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
Time frame: 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.
Time frame: 18 months
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
Time frame: 18 months
Change in BMI
BMI will measured at the start of study and at 6, 12, and 18 months.
Time frame: 18 months
Change in Waist Circumference
Waist circumference will be measured at start of study and at 6, 12, and 18 months.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Duke University