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

N/ACompletedNCT03199716

University of California, Davis27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Parent mentorsOTHER

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

UC Davis Pediatrics Endocrinology

Sacramento, California, United States

Outcomes

Primary Outcomes

Daily frequency of blood glucose monitoring (BGM)

Number of glucose monitoring events per day

Time frame: up to 12 months

Secondary Outcomes

HbA1c levels

Values of HbA1c in blood

Time frame: up to 12 months

Data from ClinicalTrials.gov

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