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

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ClinicalTrials.gov Identifier: NCT03199716
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Parent mentors Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Actual Study Start Date : September 2014
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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



Primary Outcome Measures :
  1. Daily frequency of blood glucose monitoring (BGM) [ Time Frame: up to 12 months ]
    Number of glucose monitoring events per day


Secondary Outcome Measures :
  1. HbA1c levels [ Time Frame: up to 12 months ]
    Values of HbA1c in blood


Other Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199716


Locations
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United States, California
UC Davis Pediatrics Endocrinology
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Children's Miracle Network
Investigators
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Principal Investigator: Dennis Styne, MD UC Davis Pediatrics Endocrinology
Principal Investigator: Yvonne Lee, MD UC Davis Pediatrics Endocrinology

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03199716    
Other Study ID Numbers: 615897
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases