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

NCT ID: NCT06057662

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

personalized comprehensive diabetes support

Intervention Type OTHER

personalized comprehensive diabetes support

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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personalized comprehensive diabetes support

personalized comprehensive diabetes support

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Davis

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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2059749

Identifier Type: -

Identifier Source: org_study_id

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