Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents

Study Overview
=================
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.

Official Title
-----------------
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: Parent mentors


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Mentors and Intervention Group<br>Parent mentors are parents from our UC Davis Pediatrics Endocrinology clinic who have met our parent mentor inclusion criteria; the intervention group are families in our clinic who have met our mentee family inclusion criteria | Other: Parent mentors<br>* 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<br>|
| No Intervention: Control Group with no Parent Mentors<br>The control group is made up of families at our UC Davis Pediatrics Endocrinology clinic who have met the mentee family inclusion criteria but are not matched with a parent mentor | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily frequency of blood glucose monitoring (BGM) | Number of glucose monitoring events per day | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | Values of HbA1c in blood | up to 12 months |