Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
personalized comprehensive diabetes support
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06057662
First Posted
August 8, 2023
Last Updated
September 24, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT06057662
Brief Title
Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes
Official Title
Effect of Personalized Comprehensive Diabetes Support Among Families of Children With Newly Diagnosed Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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:
Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
personalized comprehensive diabetes support for 6 months following type 1 diabetes diagnosis
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
personalized comprehensive diabetes support
Intervention Description
personalized comprehensive diabetes support
Primary Outcome Measure Information:
Title
Diabetes Distress Scale
Description
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
Title
Problem Areas in Diabetes (PAID)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes
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