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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199716
• Other study ID #: 615897
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 23, 2017

Study information

• Verified date: June 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Pediatrics Endocrinology	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes knowledge	Score measured by Diabetes Numeracy Test (DNT-15)	up to 12 months
Other	Degree of diabetes related family conflicts	Score based on Questionnaire (r-DFCS)	up to 12 months
Other	Responsibility for diabetes care	Score based on Diabetes Family Responsibility Questionnaire (DFRQ)	up to 12 months
Primary	Daily frequency of blood glucose monitoring (BGM)	Number of glucose monitoring events per day	up to 12 months
Secondary	HbA1c levels	Values of HbA1c in blood	up to 12 months