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

September 24, 2023 updated by: Caroline Schulmeister, University of California, Davis

Effect of Personalized Comprehensive Diabetes Support Among Families of 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Intervention
personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis
Other: personalized comprehensive diabetes support
personalized comprehensive diabetes support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2059749

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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