ID

33729

Description

A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01682902

Link

https://clinicaltrials.gov/show/NCT01682902

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01682902

English

Eligibility Diabetes NCT01682902

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01682902
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (visit 1)
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
treatment with the same insulin analogue by csii (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (visit 1)
Description

Insulin Analogue | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1]
C2825028
UMLS CUI [2]
C0393124
using a minimed paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (visit 1)
Description

Insulin pump Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1140609
UMLS CUI [1,2]
C0205369
glycosylated haemoglobin (hba1c) below or equal to 9.0% by central laboratory
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetic ketoacidsosis (dka) episodes requiring hospitalization within 6 months prior to the screening visit (visit 1)
Description

Diabetic Ketoacidosis Episodes Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1708385
history of abscess at the infusion site within 6 months prior to the screening visit (visit 1)
Description

Infusion site abscess

Data type

boolean

Alias
UMLS CUI [1]
C1142012
hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (visit 1)
Description

Loss of hypoglycemic warning | Hypoglycaemic episodes Severe Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1708385
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Similar models

Eligibility Diabetes NCT01682902

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01682902
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (visit 1)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Analogue | Continuous subcutaneous infusion of insulin
Item
treatment with the same insulin analogue by csii (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (visit 1)
boolean
C2825028 (UMLS CUI [1])
C0393124 (UMLS CUI [2])
Insulin pump Specified
Item
using a minimed paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (visit 1)
boolean
C1140609 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) below or equal to 9.0% by central laboratory
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetic Ketoacidosis Episodes Hospitalization Required
Item
history of diabetic ketoacidsosis (dka) episodes requiring hospitalization within 6 months prior to the screening visit (visit 1)
boolean
C0011880 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,3])
Infusion site abscess
Item
history of abscess at the infusion site within 6 months prior to the screening visit (visit 1)
boolean
C1142012 (UMLS CUI [1])
Loss of hypoglycemic warning | Hypoglycaemic episodes Severe Hospitalization Required
Item
hypoglycaemic unawareness as judged by the investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (visit 1)
boolean
C0342317 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1708385 (UMLS CUI [2,3])
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