Diabetes Self-Management & Support LIVE

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040038
• Other study ID #: Pro00043325
• Secondary ID: 1R01HL118189-01
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: April 5, 2018
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• LIVE
3-D Virtual Environment for DSMT/S
• Website
2-D Website participation for DSMT/S

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in BMI	BMI will measured at the start of study and at 6, 12, and 18 months.	18 months
Secondary	Change in Waist Circumference	Waist circumference will be measured at start of study and at 6, 12, and 18 months.	18 months
Secondary	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
Secondary	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