CClinicalTrials.gg
Enrolling by invitationNCT06057662Updated Aug 18, 2026

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

An interventional study of personalized comprehensive diabetes support in Type 1 Diabetes, sponsored by University of California, Davis. Enrolling by invitation at 1 site in United States. Open to participants aged 0 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
0 Years to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Families of children older than 16 years
  • Children from non-English speaking families
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Intervention

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

    Other: personalized comprehensive diabetes support

  • No intervention
    Control

Interventions

  • Otherpersonalized comprehensive diabetes support

    personalized comprehensive diabetes support

06

What researchers measure

Primary outcomes

  1. Diabetes Distress Scale

    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.

    Time frame: 24 months

  2. Problem Areas in Diabetes (PAID)

    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.

    Time frame: 24 months

07

Study locations

1 site
  • University of California Davis
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06057662
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Aug 1, 2023
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Aug 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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