Clinical trial NCT03199716: Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Official title: Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2017-06-27
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Daily frequency of blood glucose monitoring (BGM)
timeFrame: up to 12 months
Secondary outcomes:
measure: HbA1c levels
timeFrame: up to 12 months
Other outcomes:
measure: Diabetes knowledge
timeFrame: up to 12 months
measure: Degree of diabetes related family conflicts
timeFrame: up to 12 months
measure: Responsibility for diabetes care
timeFrame: up to 12 months
Locations:
city: Sacramento
country: United States
facility: UC Davis Pediatrics Endocrinology
state: California
Study officials:
affiliation: UC Davis Pediatrics Endocrinology
name: Dennis Styne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis Pediatrics Endocrinology
name: Yvonne Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: