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

NCT06057662 | Enrolling By Invitation

• 1 other identifier: 2059749
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention.
2. 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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis

Other: personalized comprehensive diabetes support

Control

NO INTERVENTION

Interventions

personalized comprehensive diabetes support OTHER

personalized comprehensive diabetes support

Intervention

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Families of children older than 16 years
• Children from non-English speaking families

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 28, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)