ID

12211

Beschreibung

Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02439177

Link

https://clinicaltrials.gov/show/NCT02439177

Stichworte

  1. 18.10.15 18.10.15 -
Hochgeladen am

18. Oktober 2015

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Diabetes NCT02439177

Eligibility Diabetes NCT02439177

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02439177
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects with type 1 or type 2 diabetes, for the evaluation of system accuracy also healthy subjects
Beschreibung

gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
age ≥ 18
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
signed and dated informed consent form
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - i.c.t.) or insulin pump therapy (continuous subcutaneous insulin infusion - c.s.i.i.)
Beschreibung

Continuous subcutaneous infusion of insulin; diabetes mellitus type 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0393124
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441729
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation period
Beschreibung

pregnant; breast feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test.
Beschreibung

Acute Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test.
Beschreibung

Chronic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0008679
mental incapacity or language barriers precluding adequate compliance with the test procedures
Beschreibung

Clinical Research; Disruption

Datentyp

boolean

Alias
UMLS CUI [1]
C0008972
UMLS CUI [2]
C0332453
legal incompetence or limited legal competence
Beschreibung

legal incompetence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301860
UMLS CUI [1,2]
C0231189
dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research centre)
Beschreibung

Clinical Study Sponsor; dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347796
UMLS CUI [2]
C3244310
for user performance evaluation: subjects having participated in a study with omnitest® 5 before.
Beschreibung

evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C0220825
for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness
Beschreibung

evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C0220825
anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.
Beschreibung

screening; blood

Datentyp

boolean

Alias
UMLS CUI [1]
C1409616
UMLS CUI [2]
C0005767

Ähnliche Modelle

Eligibility Diabetes NCT02439177

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02439177
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
male or female subjects with type 1 or type 2 diabetes, for the evaluation of system accuracy also healthy subjects
boolean
C0079399 (UMLS CUI [1])
age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
signed and dated informed consent form
boolean
C0021430 (UMLS CUI [1])
Continuous subcutaneous infusion of insulin; diabetes mellitus type 1
Item
for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - i.c.t.) or insulin pump therapy (continuous subcutaneous insulin infusion - c.s.i.i.)
boolean
C0393124 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
pregnant; breast feeding
Item
pregnancy or lactation period
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Acute Disease
Item
severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test.
boolean
C0001314 (UMLS CUI [1])
Chronic disease
Item
severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test.
boolean
C0008679 (UMLS CUI [1])
Clinical Research; Disruption
Item
mental incapacity or language barriers precluding adequate compliance with the test procedures
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
legal incompetence
Item
legal incompetence or limited legal competence
boolean
C1301860 (UMLS CUI [1,1])
C0231189 (UMLS CUI [1,2])
Clinical Study Sponsor; dependent
Item
dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research centre)
boolean
C2347796 (UMLS CUI [1])
C3244310 (UMLS CUI [2])
evaluation
Item
for user performance evaluation: subjects having participated in a study with omnitest® 5 before.
boolean
C0220825 (UMLS CUI [1])
evaluation
Item
for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness
boolean
C0220825 (UMLS CUI [1])
screening; blood
Item
anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.
boolean
C1409616 (UMLS CUI [1])
C0005767 (UMLS CUI [2])

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