Diabetes Self-Management & Support LIVE

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Website; Behavioral: LIVE

• Registration Number: NCT02040038
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2014-07
• Status Verified: 2017-07
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Website	Website	Participation in 2D website for DSMT/S for a period of 12 months.
LIVE Arm	LIVE	Participation in 3D virtual environment for DSMT/S for a period of 12 months.

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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 Waist Circumference	18 months	Waist circumference will be measured at start of study and 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 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 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.

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

New York University; 🇺🇸 New York, New York, United States