Diabetes Mellitus, Type 1
Conditions
Brief summary
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Detailed description
The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.
Interventions
OTHERParent mentors
Parent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications
Sponsors
Children's Miracle Network
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
for mentee families: * Residing within 60 miles of a Parent Mentor * Child diagnosed with T1DM greater than or equal to 1 year at the start of our study's data collection (February 2015) * On multiple daily injection regime or insulin pump therapy * Mean HbA1c between 8.5 - 12.5% over the last 2 clinic visits Inclusion Criteria for parent mentors: * Child diagnosed with T1DM greater than or equal to 2 years at the start of our study's data collection * Compliant with suggestions made by the diabetes care team * Mean HbA1c less than or equal to 8% over the last 2 clinic visits * No episodes of diabetic ketoacidosis, aside from initial episode at diagnosis, if applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily frequency of blood glucose monitoring (BGM) | up to 12 months | Number of glucose monitoring events per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c levels | up to 12 months | Values of HbA1c in blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes knowledge | up to 12 months | Score measured by Diabetes Numeracy Test (DNT-15) |
| Degree of diabetes related family conflicts | up to 12 months | Score based on Questionnaire (r-DFCS) |
| Responsibility for diabetes care | up to 12 months | Score based on Diabetes Family Responsibility Questionnaire (DFRQ) |
Countries
United States
Outcome results
None listed