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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
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

0 Years - 16 Years (Child)All SexesAccepts 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

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

First Posted
August 8, 2023
Last Updated
September 24, 2023
Sponsor
University of California, Davis
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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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