Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes

N/AEnrolling By InvitationNCT06057662

University of California, Davis60 enrolled

Overview

The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: 1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. 2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 0 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Families of children 16 years of age or younger with a new diagnosis * Stable living situation such that the same caregivers are anticipated to be caring for the child during the full 2-year study duration. Exclusion Criteria: * Families of children older than 16 years * Children from non-English speaking families

Outcomes

Primary Outcomes

Diabetes Distress Scale

The Distress Scale (DDS) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 72. A higher score indicates higher distress.

Time frame: 24 months

Problem Areas in Diabetes (PAID)

The Problem Areas in Diabetes (PAID) uses a 6-point Likert scale to quantify diabetes-related stress. Scores can range from 0 to 100. A higher score indicates higher distress.