Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01814787|
Recruitment Status : Completed
First Posted : March 20, 2013
Results First Posted : March 23, 2017
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: CHICA Type 2 Diabetes Module||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1369 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
Experimental: CHICA Type 2 Diabetes Module
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
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.
No Intervention: Usual Care
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.
- Number of Children With Documented Risk Factors for Type 2 Diabetes [ Time Frame: 12 months ]Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814787
|United States, Indiana|
|Indiana University School of Medicine|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Aaron E Carroll, MD, MS||Indiana University School of Medicine|
|Principal Investigator:||Tamara Hannon, MD, MS||Indiana University School of Medicine|