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

Not Applicable

• Conditions: Type 1 Diabetes

• Registration Number: NCT06057662
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes Distress Scale	24 months	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.
Problem Areas in Diabetes (PAID)	24 months	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.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States