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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: Parent mentors

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Pediatrics Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent Mentors and Intervention Group; 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; 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
No Intervention: Control Group with no Parent Mentors; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes knowledge	Score measured by Diabetes Numeracy Test (DNT-15)	up to 12 months
Degree of diabetes related family conflicts	Score based on Questionnaire (r-DFCS)	up to 12 months
Responsibility for diabetes care	Score based on Diabetes Family Responsibility Questionnaire (DFRQ)	up to 12 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Children's Miracle Network
• Investigators: Principal Investigator: Dennis Styne, MD, UC Davis Pediatrics Endocrinology; Principal Investigator: Yvonne Lee, MD, UC Davis Pediatrics Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): March 23, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 615897