Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type II
Conditions
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II, African Americans, Blacks, non-Hispanic Blacks, Randomized Control Trial, Controlled Clinical Trial, Behavioral Research, Behavioral Medicine
Brief summary
The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.
Detailed description
African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM. This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.
Interventions
BEHAVIORALTechnology Intensified
The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.
Sponsors
State University of New York at Buffalo
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥21 years * Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit * Self-identified as AA * Subject must be willing to use the FORA monitoring system for 12 months * Subjects must be able to communicate in English * Subjects must have access to a telephone (landline for data uploads) for the study period
Exclusion criteria
* Mental confusion on interview suggesting significant dementia * Participation in other diabetes clinical trials * Alcohol or drug abuse/dependency * Active psychosis or acute mental disorder * Life expectancy \<12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 months post randomization | Hemoglobin A1c (HbA1c): blood specimens collected at the 12-months follow-up visit |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeonard E Egede, MD, MS
Medical College of Wisconsin
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Age, Continuous | 56.8 years STANDARD_DEVIATION 12.7 |
| Hemoglobin A1c | 10.3 mean percentage of HbA1c STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Non-Hispanic Black | 200 Participants |
| Region of Enrollment United States | 95 Participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 105 |
| other Total, other adverse events | 0 / 95 | 0 / 105 |
| serious Total, serious adverse events | 0 / 95 | 0 / 105 |
Outcome results
None listed