ID

44005

Description

Safety of Insulin Detemir in Children With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00605137

Link

https://clinicaltrials.gov/show/NCT00605137

Keywords

Versions (2)
  1. 9/6/16 9/6/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00605137

English

Eligibility Diabetes NCT00605137

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00605137
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes for at least one year
Description

Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
Description

Basal insulin | bolus infusion | Intermediate-acting insulin | Insulin, Long-Acting | Insulin Aspart | Insulin soluble human

Data type

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2]
C1511237
UMLS CUI [3]
C0304869
UMLS CUI [4]
C0304870
UMLS CUI [5]
C1708521
UMLS CUI [6]
C0795635
hba1c below 11.0%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
willing to comply with investigator's instructions
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
Description

Capillary blood glucose measurement Self Monitoring Willing | Therapeutic procedure Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0588436
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0020615
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
impaired hepatic function
Description

Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1306571
known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the investigator or sub-investigator)
Description

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
proliferative retinopathy or maculopathy requiring acute treatment
Description

Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0334094
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0087111
uncontrolled treated/untreated hypertension
Description

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
current treatment with total daily insulin dose of more than 2.00 iu/kg
Description

Insulin regime Dose Total U/kg/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439810
UMLS CUI [1,4]
C1532634
current treatment or expected at the screening to start treatment with systemic corticosteroids
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
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Similar models

Eligibility Diabetes NCT00605137

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00605137
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 for at least one year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | bolus infusion | Intermediate-acting insulin | Insulin, Long-Acting | Insulin Aspart | Insulin soluble human
Item
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
boolean
C0650607 (UMLS CUI [1])
C1511237 (UMLS CUI [2])
C0304869 (UMLS CUI [3])
C0304870 (UMLS CUI [4])
C1708521 (UMLS CUI [5])
C0795635 (UMLS CUI [6])
Glycosylated hemoglobin A
Item
hba1c below 11.0%
boolean
C0019018 (UMLS CUI [1])
Compliance behavior
Item
willing to comply with investigator's instructions
boolean
C1321605 (UMLS CUI [1])
Capillary blood glucose measurement Self Monitoring Willing | Therapeutic procedure Hypoglycemia
Item
able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
boolean
C0457578 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Hepatic Insufficiency
Item
impaired hepatic function
boolean
C1306571 (UMLS CUI [1])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the investigator or sub-investigator)
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Insulin regime Dose Total U/kg/day
Item
current treatment with total daily insulin dose of more than 2.00 iu/kg
boolean
C0557978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1532634 (UMLS CUI [1,4])
systemic steroids
Item
current treatment or expected at the screening to start treatment with systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])
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