ID

38771

Description

Web-based Insulin Titration - An Efficacy Study; ODM derived from: https://clinicaltrials.gov/show/NCT01715090

Link

https://clinicaltrials.gov/show/NCT01715090

Keywords

Versions (1)
  1. 11/2/19 11/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01715090

English

Eligibility Diabetes Mellitus, Type 2 NCT01715090

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female between 18 and 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
once daily basal insulin therapy usage
Description

Basal insulin times per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0439511
no restriction on hba1c or fpg
Description

Hemoglobin A1c Free of Restriction | Fasting Plasma glucose Free of Restriction

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0443288
UMLS CUI [2,1]
C2584434
UMLS CUI [2,2]
C0015663
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0443288
bmi < 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
ability to read and understand the dutch language
Description

Able to read Dutch Language | Comprehension Dutch Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376241
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376241
familiarity with the internet and use of a mobile phone
Description

Familiarity Internet | Use of Mobile Phone

Data type

boolean

Alias
UMLS CUI [1,1]
C0600269
UMLS CUI [1,2]
C0282111
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1136360
ability and willingness to adhere to the protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
ability and willingness to use a web-based insulin self-titration system
Description

Insulin Self Titration | System Web Based

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0162621
UMLS CUI [1,3]
C0036588
UMLS CUI [2,1]
C0449913
UMLS CUI [2,2]
C0282111
UMLS CUI [2,3]
C1705938
confirmed written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
use of systemic corticosteroid in the last three months
Description

CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C3653708
recurrent severe hypoglycaemia or hypoglycaemic unawareness
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
active proliferative diabetic retinopathy
Description

Proliferative diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0154830
any clinically significant disease or disorder
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
Description

Study Protocol Comprehension Unable | Etiology Mental condition

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C3840291
working in night shifts
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01715090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female between 18 and 80 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin times per day
Item
once daily basal insulin therapy usage
boolean
C0650607 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Hemoglobin A1c Free of Restriction | Fasting Plasma glucose Free of Restriction
Item
no restriction on hba1c or fpg
boolean
C0019018 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
C2584434 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0443288 (UMLS CUI [2,4])
Body mass index
Item
bmi < 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Able to read Dutch Language | Comprehension Dutch Language
Item
ability to read and understand the dutch language
boolean
C0586740 (UMLS CUI [1,1])
C0376241 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
Familiarity Internet | Use of Mobile Phone
Item
familiarity with the internet and use of a mobile phone
boolean
C0600269 (UMLS CUI [1,1])
C0282111 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C1136360 (UMLS CUI [2,2])
Protocol Compliance
Item
ability and willingness to adhere to the protocol
boolean
C0525058 (UMLS CUI [1])
Insulin Self Titration | System Web Based
Item
ability and willingness to use a web-based insulin self-titration system
boolean
C0021641 (UMLS CUI [1,1])
C0162621 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
C0449913 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
Informed Consent
Item
confirmed written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
use of systemic corticosteroid in the last three months
boolean
C3653708 (UMLS CUI [1])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Disease Clinical Significance
Item
any clinically significant disease or disorder
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Study Protocol Comprehension Unable | Etiology Mental condition
Item
mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C3840291 (UMLS CUI [2,2])
Night shift worker
Item
working in night shifts
boolean
C0555008 (UMLS CUI [1])
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