ID

17162

Beskrivning

Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer; ODM derived from: https://clinicaltrials.gov/show/NCT00069628

Länk

https://clinicaltrials.gov/show/NCT00069628

Nyckelord

Versioner (1)
  1. 2016-08-29 2016-08-29 -
Uppladdad den

29 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

Engelsk

Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 1 diabetes
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
Beskrivning

Insulin regime | Insulin pump | Administration of insulin Quantity Daily

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C1140609
UMLS CUI [3,1]
C0199782
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332173
hba1c between 7.0 and 11.0%
Beskrivning

Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
stable insulin regimen for the 2 months prior to study entry and no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of lantus [glargine] insulin)
Beskrivning

Insulin regime Stable | Administration of insulin Change Planned | Injection | Insulin pump | Insulin Glargine [Lantus] Additive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1301732
UMLS CUI [3]
C1828121
UMLS CUI [4]
C1140609
UMLS CUI [5,1]
C1236501
UMLS CUI [5,2]
C0442796
agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
Beskrivning

Protocol Compliance | blood glucose determination by fingerstick Quantity per day | Home blood glucose monitor

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C2022094
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439505
UMLS CUI [3]
C0917953
comprehend written english
Beskrivning

Comprehension English Language Written

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0681288
female participants must not intend to become pregnant during the next 6 months
Beskrivning

Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032992
plan to remain in the area of the clinical center during the next 6 months
Beskrivning

Home Remaining Clinic Region

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C1527428
UMLS CUI [1,3]
C0442592
UMLS CUI [1,4]
C0017446
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069628

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
clinical diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin regime | Insulin pump | Administration of insulin Quantity Daily
Item
insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
boolean
C0557978 (UMLS CUI [1])
C1140609 (UMLS CUI [2])
C0199782 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Glycosylated hemoglobin A
Item
hba1c between 7.0 and 11.0%
boolean
C0019018 (UMLS CUI [1])
Insulin regime Stable | Administration of insulin Change Planned | Injection | Insulin pump | Insulin Glargine [Lantus] Additive
Item
stable insulin regimen for the 2 months prior to study entry and no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of lantus [glargine] insulin)
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C1828121 (UMLS CUI [3])
C1140609 (UMLS CUI [4])
C1236501 (UMLS CUI [5,1])
C0442796 (UMLS CUI [5,2])
Protocol Compliance | blood glucose determination by fingerstick Quantity per day | Home blood glucose monitor
Item
agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
boolean
C0525058 (UMLS CUI [1])
C2022094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
C0917953 (UMLS CUI [3])
Comprehension English Language Written
Item
comprehend written english
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0681288 (UMLS CUI [1,3])
Pregnancy, Planned
Item
female participants must not intend to become pregnant during the next 6 months
boolean
C0032992 (UMLS CUI [1])
Home Remaining Clinic Region
Item
plan to remain in the area of the clinical center during the next 6 months
boolean
C0442519 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
C0017446 (UMLS CUI [1,4])
Tillbaka till toppen 

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