Diabetes Mellitus Type 2NCT02160639
Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
A study testing diabetes self management support in people with Diabetes Mellitus Type 2, run by American Association of Diabetes Educators at 4 sites in United States.
Trial summary
Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- diabetes self management support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2015to May 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Diagnosis of type 2 diabetes mellitus
- HbA1c > 8
- Have not completed a diabetes self management education program in the past year
Who cannot join
- Current engagement in cancer treatment
- Diagnosis of end-stage renal disease
- Pregnant
- Receiving immunosuppressant therapy following transplant
- Diagnosis of serious mental illness
- Undergoing systemic treatment with prednisone
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cross Trails Medical Center
Cape Girardeau, Missouri, 63703
Triad Adult and Pediatric Medicine, Inc.
High Point, North Carolina, 27262
FamilyCare Health Center
Scott Depot, West Virginia, 25560
El Rio Community Health Center
Tucson, Arizona, 85701
About this study
Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.
Read the detailed description
Diabetes self management support is telephonic and will be provided by health navigators at a central call center
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- diabetes self management support
- Keywords
- diabetes self management education, diabetes self management support, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes self management supportOther
diabetes self management support is telephonic and provided by health investigators
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | usual care includes diabetes self management education |
| diabetes self management support | Active comparator | diabetes self management support in addition to usual care, which includes diabetes self management education Receives: Other: diabetes self management support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c at 3, 9, 15, and 27 months
HbA1c assessment
Measured: 0, 3, 9, 15, and 27 months
Change from baseline blood pressure at 3, 9, 15, and 27 months
blood pressure assessments
Measured: 0, 3, 9, 15, and 27 months
Change from baseline cholesterol at 3, 9, 15, and 27 months
cholesterol assessments
Measured: 0, 3, 9, 15, and 27 months
Change from baseline BMI at 3, 9, 15, and 27 months
body mass index (BMI) assessments
Measured: 0, 3, 9, 15, and 27 months
Change from baseline weight at 3, 9, 15, and 27 months
weight assessments
Measured: 0, 3, 9, 15, and 27 months
Change from baseline fasting glucose at 3, 9, 15, and 27 months
fasting glucose assessments
Measured: 0, 3, 9, 15, and 27 months
Secondary outcomes (3)
Change from baseline patient credential at 3, 9, 15, and 27 months
Patient Credential for Diabetes Patients developed by American Pharmacists Association Foundation (APhAF)
Measured: 0, 3, 9, 15, and 27 months
Change from baseline depression at 3, 9, 15, and 27 months
Patient Health Questionnaire 2 Question Screening (PHQ-2)
Measured: 0, 3, 9, 15, and 27 months
Change from baseline food security at 3, 9, 15, and 27 months
Food Security Screening Questionnaire
Measured: 0, 3, 9, 15, and 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Association of Diabetes Educators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Dawn Sherr, MS, RD, CDE, Principal investigator, American Association of Diabetes Educators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160639
- Sponsor's protocol ID
- BMS-DSMES-2014
- Status last verified
- Jul 2016
- First submitted
- 6 Jun 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
- ClinicalTrials.gov ID
- NCT02160639
- Acronym / sponsor ID
- BMS-DSMES-2014
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes self management education, diabetes self management support, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 449 participants (actual)
- Lead sponsor
- American Association of Diabetes EducatorsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 11 Jun 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.
Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.
Detailed description
Diabetes self management support is telephonic and will be provided by health navigators at a central call center
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –usual care includes diabetes self management education |
| diabetes self management support | Active comparator | Other: diabetes self management supportdiabetes self management support in addition to usual care, which includes diabetes self management education |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- Diagnosis of type 2 diabetes mellitus
- HbA1c > 8
- Have not completed a diabetes self management education program in the past year
Key exclusion criteria (6 listed)
- Current engagement in cancer treatment
- Diagnosis of end-stage renal disease
- Pregnant
- Receiving immunosuppressant therapy following transplant
- Diagnosis of serious mental illness
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 |
|---|---|---|
| diabetes self management supportdiabetes self management support is telephonic and provided by health investigators | Other | diabetes self management support |
Primary outcome
Change from baseline HbA1c at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
HbA1c assessment
Change from baseline blood pressure at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
blood pressure assessments
Change from baseline cholesterol at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
cholesterol assessments
Change from baseline BMI at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
body mass index (BMI) assessments
Change from baseline weight at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
weight assessments
Change from baseline fasting glucose at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
fasting glucose assessments
3 secondary outcomes
Change from baseline patient credential at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
Change from baseline depression at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
Change from baseline food security at 3, 9, 15, and 27 months
Time frame: 0, 3, 9, 15, and 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
Dawn Sherr, MS, RD, CDE principal investigator
American Association of Diabetes Educators
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetes self management support in people with Diabetes Mellitus Type 2, run by American Association of Diabetes Educators at 4 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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 from baseline HbA1c at 3, 9, 15, and 27 months (time frame: 0, 3, 9, 15, and 27 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016.