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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06057662
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • personalized comprehensive diabetes support — OTHER
    personalized comprehensive diabetes support

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Intervention
    personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis
  • No Intervention: Control

Primary Outcome Measure

Diabetes Distress Scale [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817-

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