Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408207
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-05-22
Brief Title:
CGM Academy for Youth with Type 1 Diabetes
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth with Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring CGM device The main questions the study aims to answer are
Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education
Explore relationships between participants glycemic outcomes with diabetes distress diabetes family responsibilities and number of hours of diabetes education
Participants in the intervention group will
receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies
participate in four in-depth online group sessions with diabetes care and education specialists
complete questionnaires three times at the time of study enrollment week 4 and 6 months
Participants in the comparison group will
receive standard education provided to all patients at CHLA
complete questionnaires three times at the time of study enrollment week 4 and 6 months
Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education
Explore relationships between participants glycemic outcomes with diabetes distress diabetes family responsibilities and number of hours of diabetes education
Participants in the intervention group will
receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies
participate in four in-depth online group sessions with diabetes care and education specialists
complete questionnaires three times at the time of study enrollment week 4 and 6 months
Participants in the comparison group will
receive standard education provided to all patients at CHLA
complete questionnaires three times at the time of study enrollment week 4 and 6 months
Detailed Description:
Youth with type 1 diabetes T1D are at increased risk for kidney failure vision loss heart disease and premature mortality due to challenges with glycemic excursions Continuous glucose monitoring CGM systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management Despite these advances youth with T1D including patients at Childrens Hospital Los Angeles CHLA fail to achieve recommended glycemic targets highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None