ID

40391

Beschrijving

Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management; ODM derived from: https://clinicaltrials.gov/show/NCT01766752

Link

https://clinicaltrials.gov/show/NCT01766752

Trefwoorden

  1. 19-01-19 19-01-19 -
  2. 17-04-20 17-04-20 -
  3. 17-04-20 17-04-20 - Sarah Riepenhausen
Houder van rechten

Medical University of Graz

Geüploaded op

17 april 2020

DOI

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Licentie

Creative Commons BY-NC 4.0

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Eligibility Type 2 Diabetes NCT01766752

Eligibility Type 2 Diabetes NCT01766752

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained after being advised of the nature of the study
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
male or female aged 18 - 90 years (both inclusive)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four
Beschrijving

Type 2 DM treated with: diet, oral or injected antidiabetics, insulin, single or combined

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0011878
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1828121
UMLS CUI [5]
C0021641
UMLS CUI [6,1]
C3274787
UMLS CUI [6,2]
C0205195
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired renal function (serum creatinine ≥3.0mg/dl)
Beschrijving

Renal insufficiency Creatinine measurement (serum)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0201976
any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
Beschrijving

Disease interferes with study protocol | Disease risk for patient safety

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1113679
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
any mental condition rendering the patient incapable of giving his consent
Beschrijving

Mental disorder | Informed Consent incapable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1550518
terminally ill patients
Beschrijving

Terminal illness

Datatype

boolean

Alias
UMLS CUI [1]
C0679247
participation in a trial within 3 months prior to this trial
Beschrijving

Recent trial participation

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332185
known or suspected allergy to insulin
Beschrijving

Insulin allergy, known or suspected

Datatype

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0571622
UMLS CUI [2,2]
C0750491

Similar models

Eligibility Type 2 Diabetes NCT01766752

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
informed consent obtained after being advised of the nature of the study
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female aged 18 - 90 years (both inclusive)
boolean
C0001779 (UMLS CUI [1])
Type 2 DM treated with: diet, oral or injected antidiabetics, insulin, single or combined
Item
type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four
boolean
C0011860 (UMLS CUI [1])
C0011878 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1828121 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
C3274787 (UMLS CUI [6,1])
C0205195 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Renal insufficiency Creatinine measurement (serum)
Item
impaired renal function (serum creatinine ≥3.0mg/dl)
boolean
C1565489 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
Disease interferes with study protocol | Disease risk for patient safety
Item
any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Mental disorder | Informed Consent incapable
Item
any mental condition rendering the patient incapable of giving his consent
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1550518 (UMLS CUI [1,3])
Terminal illness
Item
terminally ill patients
boolean
C0679247 (UMLS CUI [1])
Recent trial participation
Item
participation in a trial within 3 months prior to this trial
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Insulin allergy, known or suspected
Item
known or suspected allergy to insulin
boolean
C0571622 (UMLS CUI [1])
C0571622 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])

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