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

NCT03199716 | Completed DMC

• 1 other identifier: 615897
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Daily frequency of blood glucose monitoring (BGM)

  Number of glucose monitoring events per day

  up to 12 months

Secondary Outcomes (1)

• HbA1c levels

  up to 12 months

Other Outcomes (3)

• Diabetes knowledge

  up to 12 months

• Degree of diabetes related family conflicts

  up to 12 months

• Responsibility for diabetes care

  up to 12 months

Study Arms (2)

Parent Mentors and Intervention Group

EXPERIMENTAL

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

Control Group with no Parent Mentors

NO INTERVENTION

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

Interventions

Parent mentors OTHER

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

Parent Mentors and Intervention Group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Children's Miracle Network: collaborator

Study Sites (1)

UC Davis Pediatrics Endocrinology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dennis Styne, MD

  UC Davis Pediatrics Endocrinology

  PRINCIPAL INVESTIGATOR

• Yvonne Lee, MD

  UC Davis Pediatrics Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: June 27, 2017
• Study Start: September 1, 2014
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

US (1)