ID

31040

Description

Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00835861

Link

https://clinicaltrials.gov/show/NCT00835861

Keywords

Versions (2)
  1. 7/12/18 7/12/18 -
  2. 7/12/18 7/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 12, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Non Insulin Dependent Diabetes NCT00835861

English

Eligibility Non Insulin Dependent Diabetes NCT00835861

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
receiving prenatal care at university of north carolina (unc), chapel hill obstetric clinics and planning delivery at unc women's hospital
Description

Prenatal care | Delivery Planned

Data type

boolean

Alias
UMLS CUI [1]
C0033052
UMLS CUI [2,1]
C0005615
UMLS CUI [2,2]
C1301732
diagnosis of diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
Description

Diagnosis Diabetes Mellitus prior to Pregnancy | Oral hypoglycemic | Dietary control

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0032961
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0743195
diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (nddg)criteria
Description

Gestational Diabetes Early | Glucose tolerance test Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0085207
UMLS CUI [1,2]
C1279919
UMLS CUI [2,1]
C0017741
UMLS CUI [2,2]
C0205161
less than 24 weeks at study enrollment
Description

Enrollment

Data type

boolean

Alias
UMLS CUI [1]
C1516879
singleton or twin pregnancy
Description

Pregnancy Singleton | Pregnancy, Twin

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1313913
UMLS CUI [2]
C0152150
english or spanish speaking
Description

Able to speak English Language | Able to speak Spanish Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
end organ complications of diabetes (retinopathy, renal insufficiency, etc.)
Description

End Organ Damage from Diabetes | Retinal Diseases | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C3830315
UMLS CUI [2]
C0035309
UMLS CUI [3]
C1565489
prior need for insulin for glycemic control
Description

Patient need for Insulin | Glycaemia control

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [2]
C3267174
history of diabetic ketoacidosis (dka) or hyperosmolar state
Description

Diabetic Ketoacidosis | Hyperosmolar state

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0236013
prior adverse reaction (ie. lactic acidosis) or allergy to metformin
Description

Adverse reaction Metformin | Acidosis, Lactic | Metformin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0025598
UMLS CUI [2]
C0001125
UMLS CUI [3]
C0571648
kidney or liver disease
Description

Kidney Disease | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
significant medical co-morbidities (lupus, cystic fibrosis, etc.) hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Description

Comorbidity | Lupus Erythematosus | Cystic Fibrosis | Hypertensive disease Controlled allowed | Asthma well controlled allowed | Thyroid Disease Well controlled allowed

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0010674
UMLS CUI [4,1]
C0020538
UMLS CUI [4,2]
C2587213
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C4296063
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0040128
UMLS CUI [6,2]
C3853142
UMLS CUI [6,3]
C0683607
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Similar models

Eligibility Non Insulin Dependent Diabetes NCT00835861

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prenatal care | Delivery Planned
Item
receiving prenatal care at university of north carolina (unc), chapel hill obstetric clinics and planning delivery at unc women's hospital
boolean
C0033052 (UMLS CUI [1])
C0005615 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Diagnosis Diabetes Mellitus prior to Pregnancy | Oral hypoglycemic | Dietary control
Item
diagnosis of diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
boolean
C0011900 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
C0359086 (UMLS CUI [2])
C0743195 (UMLS CUI [3])
Gestational Diabetes Early | Glucose tolerance test Abnormal
Item
diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (nddg)criteria
boolean
C0085207 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0017741 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
Enrollment
Item
less than 24 weeks at study enrollment
boolean
C1516879 (UMLS CUI [1])
Pregnancy Singleton | Pregnancy, Twin
Item
singleton or twin pregnancy
boolean
C0032961 (UMLS CUI [1,1])
C1313913 (UMLS CUI [1,2])
C0152150 (UMLS CUI [2])
Able to speak English Language | Able to speak Spanish Language
Item
english or spanish speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
End Organ Damage from Diabetes | Retinal Diseases | Renal Insufficiency
Item
end organ complications of diabetes (retinopathy, renal insufficiency, etc.)
boolean
C3830315 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Patient need for Insulin | Glycaemia control
Item
prior need for insulin for glycemic control
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C3267174 (UMLS CUI [2])
Diabetic Ketoacidosis | Hyperosmolar state
Item
history of diabetic ketoacidosis (dka) or hyperosmolar state
boolean
C0011880 (UMLS CUI [1])
C0236013 (UMLS CUI [2])
Adverse reaction Metformin | Acidosis, Lactic | Metformin allergy
Item
prior adverse reaction (ie. lactic acidosis) or allergy to metformin
boolean
C0559546 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0001125 (UMLS CUI [2])
C0571648 (UMLS CUI [3])
Kidney Disease | Liver disease
Item
kidney or liver disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Comorbidity | Lupus Erythematosus | Cystic Fibrosis | Hypertensive disease Controlled allowed | Asthma well controlled allowed | Thyroid Disease Well controlled allowed
Item
significant medical co-morbidities (lupus, cystic fibrosis, etc.) hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
boolean
C0009488 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0020538 (UMLS CUI [4,1])
C2587213 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C4296063 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0040128 (UMLS CUI [6,1])
C3853142 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
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