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OpenTrials
Completed

NCT Number: NCT03199716

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.

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Pediatrics Endocrinology

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Daily frequency of blood glucose monitoring (BGM)

    Time frame: up to 12 months

    Number of glucose monitoring events per day

Secondary outcomes

  1. HbA1c levels

    Time frame: up to 12 months

    Values of HbA1c in blood

Other outcomes

  1. Diabetes knowledge

    Time frame: up to 12 months

    Score measured by Diabetes Numeracy Test (DNT-15)

  2. Degree of diabetes related family conflicts

    Time frame: up to 12 months

    Score based on Questionnaire (r-DFCS)

  3. Responsibility for diabetes care

    Time frame: up to 12 months

    Score based on Diabetes Family Responsibility Questionnaire (DFRQ)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Children's Miracle Network

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2017
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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