Diabetes Mellitus Type 2
Conditions
Keywords
diabetes self management education, diabetes self management support, type 2 diabetes
Brief 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 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
Interventions
OTHERdiabetes self management support
diabetes self management support is telephonic and provided by health investigators
Sponsors
Bristol-Myers Squibb
American Association of Diabetes Educators
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline fasting glucose at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | fasting glucose assessments |
| Change from baseline cholesterol at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | cholesterol assessments |
| Change from baseline BMI at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | body mass index (BMI) assessments |
| Change from baseline weight at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | weight assessments |
| Change from baseline HbA1c at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | HbA1c assessment |
| Change from baseline blood pressure at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | blood pressure assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline depression at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | Patient Health Questionnaire 2 Question Screening (PHQ-2) |
| Change from baseline food security at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | Food Security Screening Questionnaire |
| Change from baseline patient credential at 3, 9, 15, and 27 months | 0, 3, 9, 15, and 27 months | Patient Credential for Diabetes Patients developed by American Pharmacists Association Foundation (APhAF) |
Countries
United States
Outcome results
None listed