Trial Outcomes & Findings for Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes (NCT NCT01814787)
NCT ID: NCT01814787
Last Updated: 2017-05-15
Results Overview
Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (\>85%BMI and 2 of 4 Risk Factors)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1369 participants
Primary outcome timeframe
12 months
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
685
|
684
|
|
Overall Study
COMPLETED
|
685
|
684
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Automation for Diagnosis and Management of Childhood Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
CHICA Type 2 Diabetes Module
n=685 Participants
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
n=684 Participants
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
n=1369 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
685 Participants
n=93 Participants
|
684 Participants
n=4 Participants
|
1369 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
344 Participants
n=93 Participants
|
313 Participants
n=4 Participants
|
657 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=93 Participants
|
371 Participants
n=4 Participants
|
712 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
376 Participants
n=93 Participants
|
336 Participants
n=4 Participants
|
712 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
192 Participants
n=93 Participants
|
243 Participants
n=4 Participants
|
435 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
62 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of children (ages 10 and older) with documented risk factors for type 2 diabetes (\>85%BMI and 2 of 4 Risk Factors)
Outcome measures
| Measure |
CHICA Type 2 Diabetes Module
n=685 Participants
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.
|
Usual Care
n=684 Participants
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
|
283 Participants
|
282 Participants
|
Adverse Events
CHICA Type 2 Diabetes Module
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aaron E. Carroll, MD, MS
Indiana University School of Medicine
Phone: 3172789616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place