Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01814787 |
Recruitment Status :
Completed
First Posted : March 20, 2013
Results First Posted : March 23, 2017
Last Update Posted : May 15, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Screening |
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 |

Arm | Intervention/treatment |
---|---|
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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- None

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 |
Responsible Party: | Aaron Carroll, Professor of Pediatrics, Indiana University |
ClinicalTrials.gov Identifier: | NCT01814787 |
Other Study ID Numbers: |
1R01DK092717 ( U.S. NIH Grant/Contract ) 1R01DK092717 ( U.S. NIH Grant/Contract ) |
First Posted: | March 20, 2013 Key Record Dates |
Results First Posted: | March 23, 2017 |
Last Update Posted: | May 15, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Type 2 Diabetes Pediatrics Computerized Decision Support System |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |