Diabetes Mellitus, Type 1
Conditions
Brief summary
To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.
Interventions
OTHERMyDiaText
The intervention will consist of daily text messages sent to the subject's personal mobile device.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 1 diabetes for more than 1 year * HbA1c greater than or equal to 8% but less than 14%. * Have been seen in diabetes clinic in the last 6 months * Owns a personal mobile device with unlimited text messaging plan
Exclusion criteria
* Non-English speaking * Significant cognitive disability or major organ illness * Hemolytic anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months | 6 months | Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months | 6 months | Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1=never do it to 5 =always do this as recommended, without fail). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device. | 83 |
| Control This group will receive the usual standard of care for 6 months. | 82 |
| Total | 165 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 83 Participants | 82 Participants | 165 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.8 years STANDARD_DEVIATION 1.9 | 15.5 years STANDARD_DEVIATION 2.3 | 15.6 years STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 74 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 26 Participants | 20 Participants | 46 Participants |
| Race/Ethnicity, Customized Mixed Race | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 43 Participants | 54 Participants | 97 Participants |
| Region of Enrollment United States | 83 Participants | 82 Participants | 165 Participants |
| Sex/Gender, Customized Female | 35 Participants | 43 Participants | 78 Participants |
| Sex/Gender, Customized Male | 47 Participants | 38 Participants | 85 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 83 | 0 / 82 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.
Time frame: 6 months
Population: Those analyzed were those who completed at least 1 self-care inventory survey. Analysis was preformed using multilevel mixed effects linear regression model. Outcomes are model-predicted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months | 3.57 score on a scale | Standard Error 0.07 |
| Control | Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months | 3.62 score on a scale | Standard Error 0.07 |
Comparison: A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).p-value: 0.035Mixed Models Analysis
Secondary
Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Hemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1=never do it to 5 =always do this as recommended, without fail). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control.
Time frame: 6 months