ID

38863

Description

Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01079234

Link

https://clinicaltrials.gov/show/NCT01079234

Keywords

Versions (1)
  1. 11/10/19 11/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 10, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT01079234

English

Eligibility Diabetes NCT01079234

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01079234
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
Description

Insulin-Dependent Diabetes Mellitus Disease length | Injection therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0444472
current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, nph insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
Description

Basal insulin | Insulin Glargine | insulin detemir | NPH insulin | Injection Quantity Daily | Mealtime Insulin injection Quantity Daily | Insulin Aspart | Insulin Lispro | Insulin Glulisine | Human Insulin | Bolus Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2]
C0907402
UMLS CUI [3]
C0537270
UMLS CUI [4]
C0021658
UMLS CUI [5,1]
C1533685
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0332173
UMLS CUI [6,1]
C0587119
UMLS CUI [6,2]
C0199782
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C0332173
UMLS CUI [7]
C1708521
UMLS CUI [8]
C0293359
UMLS CUI [9]
C1313386
UMLS CUI [10]
C0795635
UMLS CUI [11,1]
C0557978
UMLS CUI [11,2]
C1705509
hba1c maximum 10.0 % by central laboratory analysis
Description

Hemoglobin A1c measurement Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0806909
body mass index (bmi) below or equal to 35.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
Description

Insulin regime Self-Management | Insulin dose changed

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0086969
UMLS CUI [2]
C3875568
ability and willingness to adhere to the protocol including performance of self measured plasma glucose (smpg) profiles and self adjustment of insulin doses
Description

Protocol Compliance | Plasma Glucose Measurement Self | Insulin Dose Adjustment Self

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0036588
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456081
UMLS CUI [3,4]
C0036588
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use within the last 3 months prior to visit 1 of any antidiabetic glucose lowering drug other than insulin
Description

Hypoglycemic Agents | Exception Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Description

Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0581377
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0162577
uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure above or equal to 100 mmhg)
Description

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Description

Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0455471
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
Back to the top of the page

Similar models

Eligibility Diabetes NCT01079234

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01079234
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Injection therapy
Item
type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0444472 (UMLS CUI [2])
Basal insulin | Insulin Glargine | insulin detemir | NPH insulin | Injection Quantity Daily | Mealtime Insulin injection Quantity Daily | Insulin Aspart | Insulin Lispro | Insulin Glulisine | Human Insulin | Bolus Insulin regime
Item
current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, nph insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
boolean
C0650607 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0537270 (UMLS CUI [3])
C0021658 (UMLS CUI [4])
C1533685 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0332173 (UMLS CUI [5,3])
C0587119 (UMLS CUI [6,1])
C0199782 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0332173 (UMLS CUI [6,4])
C1708521 (UMLS CUI [7])
C0293359 (UMLS CUI [8])
C1313386 (UMLS CUI [9])
C0795635 (UMLS CUI [10])
C0557978 (UMLS CUI [11,1])
C1705509 (UMLS CUI [11,2])
Hemoglobin A1c measurement Maximum
Item
hba1c maximum 10.0 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin regime Self-Management | Insulin dose changed
Item
ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
boolean
C0557978 (UMLS CUI [1,1])
C0086969 (UMLS CUI [1,2])
C3875568 (UMLS CUI [2])
Protocol Compliance | Plasma Glucose Measurement Self | Insulin Dose Adjustment Self
Item
ability and willingness to adhere to the protocol including performance of self measured plasma glucose (smpg) profiles and self adjustment of insulin doses
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456081 (UMLS CUI [3,3])
C0036588 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Insulin
Item
use within the last 3 months prior to visit 1 of any antidiabetic glucose lowering drug other than insulin
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial