Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01814787
• Other study ID #: 1R01DK092717
• Secondary ID: 1R01DK092717
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2013
• Last updated: September 6, 2016
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1423
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• A patient's chart will be eligible for chart abstraction if the child is age 10 or older and is a patient at one of the four clinics involved in the study.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• CHICA Type 2 Diabetes Module
Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician whether the child might have insulin resistance. All information will then be analyzed to determine whether the child has 2 or more risk factors for the development of type 2 diabetes. If at least 2 risk factors are present, then the CHICA system goes on to coordinate the diagnosis and long-term management of type 2 diabetes.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of children with documented risk factors for type 2 diabetes	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)	12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes scheduled for FPG		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes completing FPG		12 month	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes scheduled for follow-up appointment with pediatrician		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes attending follow-up appointment with pediatrician		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Positive" FPG Lab results (FPG>125)		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes "Borderline" FPG Lab results (125>= FPG > 100)		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Positive" HbA1C (HbA1C >= 6.5%)		12 months	No
Secondary	Percent of children (ages 10 and older) with documented risk factors for type 2 diabetes with "Borderline" HbA1C (6.5% > HbA1C >= 5.7%)		12 months	No
Secondary	Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs scheduled for OGTT		12 months	No
Secondary	Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs completing OGTT		12 months	No
Secondary	Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs scheduled for follow-up appointment with pediatrician		12 months	No
Secondary	Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs attending follow-up appointment with pediatrician		12 months	No
Secondary	Percent of children (ages 10 and older) with "Borderline" FPG or HbA1C Labs with "Positive" OGTT (OGTT > 199)		12 months	No
Secondary	Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C = 6.5%) referred to pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C = 6.5%) attending appointment with pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with "Positive" FPG or HbA1C Lab results (FPG > 125) or HbA1C = 6.5%) with follow-up letter sent to pediatrician by pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT > 199 referred to pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT > 199 attending appointment with pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT > 199 with follow-up letter sent to pediatrician by pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT between 140 and 199) referred to pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT between 140 and 199) attending appointment with pediatric endocrinologist		12 months	No
Secondary	Percent of children (ages 10 and older) with OGTT between 140 and 199) with follow-up letter sent to pediatrician by pediatric endocrinologist		12 months	No