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

• Sponsor: University of California, Davis (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06057662
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 47
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Other: personalized comprehensive diabetes support	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes
• Actual Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Diabetes Distress Scale [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 16 Years
• Sexes Eligible for Study: 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:

• Families of children older than 16 years

• Children from non-English speaking families

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caroline Schulmeister, Assistant Professor, University of California, Davis
• ClinicalTrials.gov Identifier: NCT06057662
• Other Study ID Numbers: 2059749
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Sep 28, 2023