ID

37305

Descripción

Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy; ODM derived from: https://clinicaltrials.gov/show/NCT02064023

Link

https://clinicaltrials.gov/show/NCT02064023

Palabras clave

Versiones (1)
  1. 15/7/19 15/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes NCT02064023

Inglés

Eligibility Type 1 Diabetes NCT02064023

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects are attending the diabetes pregnancy clinic at participating hospitals
Descripción

Study Subject Attending Diabetes in pregnancy clinic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C3839840
have had type 1 or type 2 diabetes for at least one year
Descripción

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
are in the first trimester or are actively attempting pregnancy
Descripción

Pregnancy Trimester, First | Pregnancy Attempt

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032979
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1516084
have a singleton pregnancy
Descripción

Single pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0341899
are receiving intensive insulin therapy
Descripción

Insulin regime With intensity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0522510
are judged by clinic staff to be capable of using an insulin pump
Descripción

Capability Use of Insulin pump

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1140609
are age 19 or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
are willing to adhere to the study protocol including monitoring blood glucose levels
Descripción

Protocol Compliance | Blood glucose monitoring

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C3669205
are willing to take folic acid before pregnancy and during the first trimester
Descripción

Intake Folic Acid Before Pregnancy | Intake Folic Acid During First Trimester

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0016410
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0032961
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0016410
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0032979
are willing to discontinue any medication contraindicated in pregnancy prior to conception
Descripción

Pharmaceutical Preparations Contraindicated Pregnancy | Pharmaceutical Preparations Discontinue Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0032961
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0600109
weigh less than 100 kg (220 lb) prior to becoming pregnant
Descripción

Body Weight Before Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0032961
use less than 100 units of insulin per day
Descripción

Insulin U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0456683
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous use of an insulin pump
Descripción

Use of Insulin pump

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1140609
use of fertility treatments
Descripción

Treatment Fertility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0015895
have a multiple pregnancy
Descripción

Multiple Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032989
have had children born with major birth defects
Descripción

Childbirth Birth defects Major

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1148523
UMLS CUI [1,2]
C0220810
UMLS CUI [1,3]
C0205164
have experienced stillbirth or multiple early pregnancy losses
Descripción

Stillbirth | Early pregnancy loss multiple

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0595939
UMLS CUI [2,1]
C3830362
UMLS CUI [2,2]
C0439064
have significant diabetes complications or a serious medical issue
Descripción

Complications of Diabetes Mellitus | Medical Problem Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0205404
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Similar models

Eligibility Type 1 Diabetes NCT02064023

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Attending Diabetes in pregnancy clinic
Item
subjects are attending the diabetes pregnancy clinic at participating hospitals
boolean
C0681850 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C3839840 (UMLS CUI [1,3])
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
have had type 1 or type 2 diabetes for at least one year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Pregnancy Trimester, First | Pregnancy Attempt
Item
are in the first trimester or are actively attempting pregnancy
boolean
C0032979 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
Single pregnancy
Item
have a singleton pregnancy
boolean
C0341899 (UMLS CUI [1])
Insulin regime With intensity
Item
are receiving intensive insulin therapy
boolean
C0557978 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Capability Use of Insulin pump
Item
are judged by clinic staff to be capable of using an insulin pump
boolean
C2698977 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1140609 (UMLS CUI [1,3])
Age
Item
are age 19 or older
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Blood glucose monitoring
Item
are willing to adhere to the study protocol including monitoring blood glucose levels
boolean
C0525058 (UMLS CUI [1])
C3669205 (UMLS CUI [2])
Intake Folic Acid Before Pregnancy | Intake Folic Acid During First Trimester
Item
are willing to take folic acid before pregnancy and during the first trimester
boolean
C1512806 (UMLS CUI [1,1])
C0016410 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
C1512806 (UMLS CUI [2,1])
C0016410 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0032979 (UMLS CUI [2,4])
Pharmaceutical Preparations Contraindicated Pregnancy | Pharmaceutical Preparations Discontinue Willing
Item
are willing to discontinue any medication contraindicated in pregnancy prior to conception
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Body Weight Before Pregnancy
Item
weigh less than 100 kg (220 lb) prior to becoming pregnant
boolean
C0005910 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Insulin U/day
Item
use less than 100 units of insulin per day
boolean
C0021641 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Use of Insulin pump
Item
current or previous use of an insulin pump
boolean
C1524063 (UMLS CUI [1,1])
C1140609 (UMLS CUI [1,2])
Treatment Fertility
Item
use of fertility treatments
boolean
C0087111 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
Multiple Pregnancy
Item
have a multiple pregnancy
boolean
C0032989 (UMLS CUI [1])
Childbirth Birth defects Major
Item
have had children born with major birth defects
boolean
C1148523 (UMLS CUI [1,1])
C0220810 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Stillbirth | Early pregnancy loss multiple
Item
have experienced stillbirth or multiple early pregnancy losses
boolean
C0595939 (UMLS CUI [1])
C3830362 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
Complications of Diabetes Mellitus | Medical Problem Serious
Item
have significant diabetes complications or a serious medical issue
boolean
C0342257 (UMLS CUI [1])
C1254481 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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