Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes

NCT01814787 | Completed Results

• 1 other identifier: 1R01DK092717
• Study Type: interventional
• Target: 1,369
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Pediatrics; Computerized Decision Support System

Outcome Measures

Primary Outcomes (1)

• Number of Children With Documented Risk Factors for Type 2 Diabetes

  Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (\>85%BMI and 2 of 4 Risk Factors)

  12 months

Study Arms (2)

CHICA Type 2 Diabetes Module

EXPERIMENTAL

Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.

Other: CHICA Type 2 Diabetes Module

Usual Care

NO INTERVENTION

Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child's BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.

Interventions

CHICA Type 2 Diabetes Module OTHER

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.

CHICA Type 2 Diabetes Module

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Hannon TS, Dugan TM, Saha CK, McKee SJ, Downs SM, Carroll AE. Effectiveness of Computer Automation for the Diagnosis and Management of Childhood Type 2 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Apr 1;171(4):327-334. doi: 10.1001/jamapediatrics.2016.4207.

  PMID: 28192551 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Aaron E. Carroll, MD, MS
• Organization: Indiana University School of Medicine

aaecarro@iu.edu

3172789616

Study Officials

• Aaron E Carroll, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Tamara Hannon, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-04

Locations

US (1)