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Trial record 1 of 8229 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

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.

Participant Flow:   Overall Study
    CHICA Type 2 Diabetes Module   Usual Care
STARTED   685   684 
COMPLETED   685   684 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.
Total Total of all reporting groups

Baseline Measures
   CHICA Type 2 Diabetes Module   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 685   684   1369 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      344  50.2%      313  45.8%      657  48.0% 
Male      341  49.8%      371  54.2%      712  52.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Black   376   336   712 
Hispanic   192   243   435 
White   55   59   114 
Other/Unknown   62   46   108 


  Outcome Measures

1.  Primary:   Number of Children With Documented Risk Factors for Type 2 Diabetes   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: aaecarro@iu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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