Diabetes Mellitus, Type 2NCT02040038
Diabetes Self-Management & Support LIVE
A study testing LIVE and Website in people with Diabetes Mellitus, Type 2, run by Duke University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LIVE and Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
New York University
New York, New York, 10003
About this study
Official title: Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LIVE, Website
- Keywords
- Diabetes, Virtual Environment, Self-Management
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVEBehavioural
3-D Virtual Environment for DSMT/S
WebsiteBehavioural
2-D Website participation for DSMT/S
| Study group | Role | What they receive |
|---|---|---|
| LIVE Arm | Experimental | Participation in 3D virtual environment for DSMT/S for a period of 12 months. Receives: Behavioral: LIVE |
| Website | Active comparator | Participation in 2D website for DSMT/S for a period of 12 months. Receives: Behavioral: Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 18 months
Secondary outcomes (5)
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
Measured: 18 months
Change in BMI
BMI will measured at the start of study and at 6, 12, and 18 months.
Measured: 18 months
Change in Waist Circumference
Waist circumference will be measured at start of study and at 6, 12, and 18 months.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Constance M. Johnson, PhD, Principal investigator, Duke University School of NursingAllison Vorderstrasse, DNSc, Principal investigator, Duke University School of NursingGail Melkus, EdD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040038
- Sponsor's protocol ID
- Pro00043325
- Other IDs
- 1R01HL118189-01
- Status last verified
- Jul 2017
- First submitted
- 16 Jan 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson CM, D'Eramo Melkus G, Reagan L, Pan W, Amarasekara S, Pereira K, Hassell N, Nowlin S, Vorderstrasse A. Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial. JMIR Form Res. 2023 Apr 20;7:e40359. doi: 10.2196/40359.
PubMed 36962700Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6.
PubMed 28600025Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128.
PubMed 26505161
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
- ClinicalTrials.gov ID
- NCT02040038
- Acronym / sponsor ID
- Pro00043325
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Virtual Environment, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIVE Arm | Experimental | Behavioral: LIVEParticipation in 3D virtual environment for DSMT/S for a period of 12 months. |
| Website | Active comparator | Behavioral: WebsiteParticipation in 2D website for DSMT/S for a period of 12 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIVE3-D Virtual Environment for DSMT/S | Behavioural | LIVE Arm |
| Website2-D Website participation for DSMT/S | Behavioural | Website |
Primary outcome
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
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.
5 secondary outcomes
Change in HbA1C level
Time frame: 18 months
Change in BMI
Time frame: 18 months
Change in Waist Circumference
Time frame: 18 months
Change in Blood Pressure
Time frame: 18 months
Change in Lipid Levels
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 36962700Johnson CM, D'Eramo Melkus G, Reagan L, Pan W, Amarasekara S, Pereira K, Hassell N, Nowlin S, Vorderstrasse A. Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial. JMIR Form Res. 2023 Apr 20;7:e40359. doi: 10.2196/40359.
- Derived from this study: PubMed 28600025Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6.
- Derived from this study: PubMed 26505161Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance M. Johnson, PhD principal investigator
Duke University School of Nursing
Allison Vorderstrasse, DNSc principal investigator
Duke University School of Nursing
Gail Melkus, EdD principal investigator
New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIVE and Website in people with Diabetes Mellitus, Type 2, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Intake (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040038, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.