ID

24010

Beskrivning

Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide; ODM derived from: https://clinicaltrials.gov/show/NCT00569907

Länk

https://clinicaltrials.gov/show/NCT00569907

Nyckelord

Versioner (1)
  1. 2017-07-22 2017-07-22 -
Uppladdad den

22 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT00569907

Engelsk

Eligibility Diabetes Mellitus Type 2 NCT00569907

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study)
Beskrivning

Gender | Childbearing Potential Contraceptive methods | Tubal Ligation | Contraceptives, Oral | Sexual Abstinence | Partner had vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0520483
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0420842
previously diagnosed with type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
age 21 and older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved fda indications)
Beskrivning

Metformin | Sulfonylurea | Thiazolidinediones | Combined Modality Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0009429
hba1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on hba1c level.
Beskrivning

Glycosylated hemoglobin A | exenatide

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2]
C0167117
willing to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
motivated and capable of following the protocol and instructions provided by the healthcare professional
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
available for the study on the scheduled visit days
Beskrivning

Patient Available Visit Day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C2827038
access to telephone communications
Beskrivning

Access to telephone Communication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0009452
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
under 21 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
creatinine clearance <30 ml/min (using mdrd formula)
Beskrivning

Creatinine clearance measurement Formula MDRD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C1980036
known gastrointestinal disease
Beskrivning

Gastrointestinal Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0017178
without diabetes or known type 1 diabetes
Beskrivning

Diabetes Mellitus Absent | Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0011854
unable to follow the study protocol
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
unable to read and write in english
Beskrivning

Able to read English Language | Able to write English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
allergy to adhesives
Beskrivning

Allergy to adhesive

Datatyp

boolean

Alias
UMLS CUI [1]
C1635164
any concomitant medical condition that would likely affect the evaluation of cgm device performance as determined by the investigator such as dermatological conditions or myxedema.
Beskrivning

Medical condition Affecting Evaluation Glucose monitoring device | Dermatologic disorders | Myxedema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0202048
UMLS CUI [2]
C0037274
UMLS CUI [3]
C0027145
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT00569907

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Childbearing Potential Contraceptive methods | Tubal Ligation | Contraceptives, Oral | Sexual Abstinence | Partner had vasectomy
Item
male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study)
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0520483 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0420842 (UMLS CUI [6])
Diabetes Mellitus, Non-Insulin-Dependent
Item
previously diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
age 21 and older
boolean
C0001779 (UMLS CUI [1])
Metformin | Sulfonylurea | Thiazolidinediones | Combined Modality Therapy
Item
treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved fda indications)
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Glycosylated hemoglobin A | exenatide
Item
hba1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on hba1c level.
boolean
C0019018 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
Informed Consent
Item
willing to give informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
motivated and capable of following the protocol and instructions provided by the healthcare professional
boolean
C0525058 (UMLS CUI [1])
Patient Available Visit Day
Item
available for the study on the scheduled visit days
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C2827038 (UMLS CUI [1,3])
Access to telephone Communication
Item
access to telephone communications
boolean
C1822200 (UMLS CUI [1,1])
C0009452 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
under 21 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Creatinine clearance measurement Formula MDRD
Item
creatinine clearance <30 ml/min (using mdrd formula)
boolean
C0373595 (UMLS CUI [1,1])
C1980036 (UMLS CUI [1,2])
Gastrointestinal Disease
Item
known gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Diabetes Mellitus Absent | Diabetes Mellitus, Insulin-Dependent
Item
without diabetes or known type 1 diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011854 (UMLS CUI [2])
Protocol Compliance Unable
Item
unable to follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Able to read English Language | Able to write English Language
Item
unable to read and write in english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Allergy to adhesive
Item
allergy to adhesives
boolean
C1635164 (UMLS CUI [1])
Medical condition Affecting Evaluation Glucose monitoring device | Dermatologic disorders | Myxedema
Item
any concomitant medical condition that would likely affect the evaluation of cgm device performance as determined by the investigator such as dermatological conditions or myxedema.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0202048 (UMLS CUI [1,4])
C0037274 (UMLS CUI [2])
C0027145 (UMLS CUI [3])
Tillbaka till toppen 

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