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OpenTrials
Completed

NCT Number: NCT02040038

Diabetes Self-Management & Support LIVE

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

LIVE

Behavioral

3-D Virtual Environment for DSMT/S

Website

Behavioral

2-D Website participation for DSMT/S

Primary outcomes

  1. Change in Dietary Intake

    Time frame: 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

  2. Change in Physical Activity

    Time frame: 18 months

    Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months.

Secondary outcomes

  1. Change in HbA1C level

    Time frame: 18 months

    Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months

  2. Change in BMI

    Time frame: 18 months

    BMI will measured at the start of study and at 6, 12, and 18 months.

  3. Change in Waist Circumference

    Time frame: 18 months

    Waist circumference will be measured at start of study and at 6, 12, and 18 months.

  4. Change in Blood Pressure

    Time frame: 18 months

    Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months.

  5. Change in Lipid Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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