Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01814787
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2013-03-18
Brief Title:
Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Increasing rates of type 2 diabetes among children and adolescents has considerable long-term implications not only for the affected individuals but also for society and the health system as a whole Pediatricians have unique and important opportunities to screen for type 2 diabetes and to promote lifestyle modification for those children identified with pre-diabetes yet implementation of these practices within the pediatric primary care setting is far from ideal The purpose of this study is to implement the ADA screening guidelines for type 2 diabetes and clinical management prompts within a pediatric primary care setting using a computer decision support system CDSS developed by the investigators research group - the Child Health Improvement through Computer Automation CHICA system The investigators hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance with ADA recommended screening procedures as well as better clinical management of children identified as having pre-diabetes or type 2 diabetes
Detailed Description:
As the prevalence of obesity in the United States has risen so too has the prevalence of type 2 diabetes a disease typically associated with adults The American Diabetes Association ADA has recommended screening children 10 years of age or older who are at substantial risk for the presence or development of type 2 diabetes They also recommend that primary prevention efforts such as lifestyle modification be directed to high-risk children whose glucose levels are elevated but not yet diagnostic of diabetes The choice of screening methodology remains controversial and implementation within the pediatric primary care setting is far from ideal The purpose of this study is to implement the ADA screening guidelines for type 2 diabetes within pediatric primary care practices using a computer decision support system CDSS developed by the investigators research group - the Child Health Improvement through Computer Automation CHICA system Using the CHICA system the investigators will also be implementing clinical management prompts for the pediatrician caring for children with risk factors for type 2 diabetes with impaired fasting glucose IFG or with fasting glucose indicating the possibility of diabetes One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources in this case the ADA in a format that integrates easily into routine pediatric care the system can therefore overcome many of the barriers described by pediatricians to the screening of type 2 diabetes in children While the use of CDSS is not new its application within the pediatric population has not been as pervasive as in adult medicine Moreover the application of CDSS to the screening diagnosis and management of type 2 diabetes in children is relatively unexplored The specific aims for this study are to 1 Expand and modify an existing computer-based decision support system CHICA to identify those children 10 years of age or older who are at increased risk for type 2 diabetes to provide pediatric physicians guidelines to screen for type 2 diabetes and to coordinate the diagnosis and long-term management of the condition and 2 Demonstrate both the feasibility and effectiveness of the CHICA Type 2 Diabetes Module to recognize those children in need of screening for type 2 diabetes and facilitate prompt diagnosis and management of the condition Phase one Aim 1 focuses on programming and enhancements to the CHICA system and will take 12 months to complete Phase two consists of a randomized controlled trial conducted in four pediatric clinics in order to evaluate Aim 2 Randomization will be by clinic and the investigators hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance with ADA recommended screening procedures as well as better clinical management of children identified as having pre-diabetes or type 2 diabetes Phase two will begin in year 2 and continue through quarter 2 of year 4 Phase three involves statistical analysis and manuscript preparation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK092717 | NIH | None | httpsreporternihgovquickSearch1R01DK092717 |