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OpenTrials
Enrolling by Invitation

NCT Number: NCT06057662

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

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.

Enrolling by Invitation

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

0 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

personalized comprehensive diabetes support

Other

personalized comprehensive diabetes support

Primary outcomes

  1. Diabetes Distress Scale

    Time frame: 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.

  2. Problem Areas in Diabetes (PAID)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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