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

University of California (UC) Davis

Status: Invitation-only

Conditions: Type 1 Diabetes

Treatments: Other: personalized comprehensive diabetes support

Study type: Interventional

Funder types: Other

Identifiers

NCT06057662

2059749

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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

Treatment:

Other: personalized comprehensive diabetes support

Control

No Intervention group