ID

17173

Beskrivning

Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials; ODM derived from: https://clinicaltrials.gov/show/NCT00105352

Länk

https://clinicaltrials.gov/show/NCT00105352

Nyckelord

Versioner (1)
  1. 2016-08-30 2016-08-30 -
Uppladdad den

30 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00105352

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT00105352

1 Formulär  
Criteria
Beskrivning

Criteria

age 8 - 35 years at the time of inclusion
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body weight > 30 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
type 1 diabetes defined by: ada (american diabetes association) criteria or judgment of physician
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
duration of diabetes: 1 month to 3* years (*the trialnet coordinating center will monitor fasting c-peptide levels as they are reported to ensure that a wide range of values is included. this review may result in widening the duration of diabetes window to allow for subjects with low c-peptide).
Beskrivning

Diabetes disease length | fasting C-peptide level | Low C-peptide levels

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C2208720
UMLS CUI [3]
C4013229
must maintain good glycemic control
Beskrivning

Glycemic Index

Datatyp

boolean

Alias
UMLS CUI [1]
C1136206
be willing to travel to a trialnet clinical center for a minimum of four separate visits that are spaced 3-10 days apart, and be willing to complete the study within a six week period.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists)
Beskrivning

Pharmaceutical Preparations Affecting beta Cell function | Oral hypoglycemic | Adrenergic beta-2 Receptor Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0030281
UMLS CUI [1,4]
C0031843
UMLS CUI [2]
C0359086
UMLS CUI [3]
C2936789
actual treatment with drugs influencing insulin sensitivity (e.g. steroids)
Beskrivning

Pharmaceutical Preparations Affecting Insulin Sensitivity | Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0920563
UMLS CUI [2]
C0038317
significant concomitant disease likely to interfere with glucose metabolism (e.g. febrile illness within the prior 3 days)
Beskrivning

Comorbidity Significant Interferes with glucose metabolism | Disorder characterized by fever

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0596620
UMLS CUI [2]
C0743841
expected poor compliance
Beskrivning

Poor compliance Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C1517001
if a female of child-bearing age, currently pregnant or not using a form of birth control
Beskrivning

Childbearing Potential Age Contraceptive methods | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0032961
any other condition that by the judgement of the investigator may be potentially harmful to the patients
Beskrivning

Condition At risk Patients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00105352

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
age 8 - 35 years at the time of inclusion
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight > 30 kg
boolean
C0005910 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes defined by: ada (american diabetes association) criteria or judgment of physician
boolean
C0011854 (UMLS CUI [1])
Diabetes disease length | fasting C-peptide level | Low C-peptide levels
Item
duration of diabetes: 1 month to 3* years (*the trialnet coordinating center will monitor fasting c-peptide levels as they are reported to ensure that a wide range of values is included. this review may result in widening the duration of diabetes window to allow for subjects with low c-peptide).
boolean
C0011847 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2208720 (UMLS CUI [2])
C4013229 (UMLS CUI [3])
Glycemic Index
Item
must maintain good glycemic control
boolean
C1136206 (UMLS CUI [1])
Protocol Compliance
Item
be willing to travel to a trialnet clinical center for a minimum of four separate visits that are spaced 3-10 days apart, and be willing to complete the study within a six week period.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting beta Cell function | Oral hypoglycemic | Adrenergic beta-2 Receptor Agonists
Item
actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0030281 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0359086 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Insulin Sensitivity | Steroids
Item
actual treatment with drugs influencing insulin sensitivity (e.g. steroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0920563 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
Comorbidity Significant Interferes with glucose metabolism | Disorder characterized by fever
Item
significant concomitant disease likely to interfere with glucose metabolism (e.g. febrile illness within the prior 3 days)
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C0743841 (UMLS CUI [2])
Poor compliance Expected
Item
expected poor compliance
boolean
C0032646 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Childbearing Potential Age Contraceptive methods | Pregnancy
Item
if a female of child-bearing age, currently pregnant or not using a form of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
Condition At risk Patients
Item
any other condition that by the judgement of the investigator may be potentially harmful to the patients
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
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