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Trial record 1 of 8403 for:    Type 2 Diabetes
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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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Aaron Carroll, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Screening
Condition Type 2 Diabetes
Intervention Other: CHICA Type 2 Diabetes Module
Enrollment 1369
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHICA Type 2 Diabetes Module Usual Care
Hide Arm/Group Description

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.

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

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.
Period Title: Overall Study
Started 685 684
Completed 685 684
Not Completed 0 0
Arm/Group Title CHICA Type 2 Diabetes Module Usual Care Total
Hide Arm/Group Description

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.

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 685 684 1369
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 685 participants 684 participants 1369 participants
<=18 years
685
 100.0%
684
 100.0%
1369
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 685 participants 684 participants 1369 participants
Female
344
  50.2%
313
  45.8%
657
  48.0%
Male
341
  49.8%
371
  54.2%
712
  52.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 685 participants 684 participants 1369 participants
Black
376
  54.9%
336
  49.1%
712
  52.0%
Hispanic
192
  28.0%
243
  35.5%
435
  31.8%
White
55
   8.0%
59
   8.6%
114
   8.3%
Other/Unknown
62
   9.1%
46
   6.7%
108
   7.9%
1.Primary Outcome
Title Number of Children With Documented Risk Factors for Type 2 Diabetes
Hide Description Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CHICA Type 2 Diabetes Module Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 685 684
Measure Type: Count of Participants
Unit of Measure: Participants
283
  41.3%
282
  41.2%
Time Frame two years
Adverse Event Reporting Description Study progress and safety will be reviewed monthly. An annual report will be compiled and will include a list and summarization of adverse events. In addition, the annual report will address (1) whether adverse event rates are consistent with pre-study assumptions; (2) whether continuation of the study is justified on the basis that additional data are needed to accomplish the stated aims of the study; and (3) conditions whereby the study might be terminated prematurely.
 
Arm/Group Title CHICA Type 2 Diabetes Module Usual Care
Hide Arm/Group Description 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. 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.
All-Cause Mortality
CHICA Type 2 Diabetes Module Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CHICA Type 2 Diabetes Module Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/685 (0.00%)   0/684 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CHICA Type 2 Diabetes Module Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/685 (0.00%)   0/684 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aaron E. Carroll, MD, MS
Organization: Indiana University School of Medicine
Phone: 3172789616
Responsible Party: Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier: NCT01814787     History of Changes
Other Study ID Numbers: 1R01DK092717 ( U.S. NIH Grant/Contract )
1R01DK092717 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: December 8, 2016
Results First Posted: March 23, 2017
Last Update Posted: May 15, 2017