ID

20715

Beschreibung

The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00147342

Link

https://clinicaltrials.gov/show/NCT00147342

Stichworte

Versionen (1)
  1. 13.03.17 13.03.17 -
Hochgeladen am

13. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type I NCT00147342

Englisch

Eligibility Diabetes Mellitus, Type I NCT00147342

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 1 diabetes for at least 18 months (the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed.)
Beschreibung

Insulin-Dependent Diabetes Mellitus disease length | C-peptide measurement | Antibody measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0202100
UMLS CUI [3]
C0201278
hba1c <10.0% (the dca2000 will be used to assess eligibility.)
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
age 8.0 to <18.0 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
weight >39.5 kg at reinfusion centers and >46.0 kg at discard centers
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
bmi >5th and <95th percentiles for age and gender
Beschreibung

Body mass index Percentile | Age | Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C1264641
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (stable is defined as no change in the overall insulin program, i.e., no change from sc injections to pump.)
Beschreibung

Insulin regime Stable | Subcutaneous injection of insulin | Insulin pump

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0586328
UMLS CUI [3]
C1140609
insulin regimen involves use of an insulin pump
Beschreibung

Insulin regime Involvement with Insulin pump

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1140609
normal thyroid function (measured within the previous year)
Beschreibung

Thyroid function normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0740378
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a recent injury to body or limb, addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
Beschreibung

Injury of body structure | Limb injury | Addison Disease | Myopathy | Injury Affecting Exercise regime Completion | Pharmaceutical Preparation Affecting Exercise regime Completion | Disease Affecting Exercise regime Completion

Datentyp

boolean

Alias
UMLS CUI [1]
C0560611
UMLS CUI [2]
C0743668
UMLS CUI [3]
C0001403
UMLS CUI [4]
C0026848
UMLS CUI [5,1]
C3263723
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0454291
UMLS CUI [5,4]
C0205197
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0454291
UMLS CUI [6,4]
C0205197
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0454291
UMLS CUI [7,4]
C0205197
asthma which has been medically treated within the last year
Beschreibung

Asthma Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1522326
current use of glucocorticoid medication (by any route of administration)
Beschreibung

Glucocorticoids Administration Route Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C1552551
current use of a beta blocker medication
Beschreibung

Adrenergic beta-1 Receptor Antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0304516
use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
Beschreibung

Pseudoephedrine

Datentyp

boolean

Alias
UMLS CUI [1]
C0033798
severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
Beschreibung

Hypoglycemia Severe Resulting in Seizure | Hypoglycemia Severe Resulting in Unconscious State | Hypoglycemia Episode Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0036572
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332294
UMLS CUI [2,4]
C0041657
UMLS CUI [3,1]
C0020615
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C0205082
active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred)
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport)
Beschreibung

Exercise regime Change Anticipated | Sports Started | Sports stopped

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0454291
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C3840775
UMLS CUI [2,1]
C0038039
UMLS CUI [2,2]
C1272689
UMLS CUI [3,1]
C0038039
UMLS CUI [3,2]
C1272691
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type I NCT00147342

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus disease length | C-peptide measurement | Antibody measurement
Item
clinical diagnosis of type 1 diabetes for at least 18 months (the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed.)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0202100 (UMLS CUI [2])
C0201278 (UMLS CUI [3])
Glycosylated hemoglobin A Percentage
Item
hba1c <10.0% (the dca2000 will be used to assess eligibility.)
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Age
Item
age 8.0 to <18.0 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
weight >39.5 kg at reinfusion centers and >46.0 kg at discard centers
boolean
C0005910 (UMLS CUI [1])
Body mass index Percentile | Age | Gender
Item
bmi >5th and <95th percentiles for age and gender
boolean
C1305855 (UMLS CUI [1,1])
C1264641 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Insulin regime Stable | Subcutaneous injection of insulin | Insulin pump
Item
stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (stable is defined as no change in the overall insulin program, i.e., no change from sc injections to pump.)
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0586328 (UMLS CUI [2])
C1140609 (UMLS CUI [3])
Insulin regime Involvement with Insulin pump
Item
insulin regimen involves use of an insulin pump
boolean
C0557978 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1140609 (UMLS CUI [1,3])
Thyroid function normal
Item
normal thyroid function (measured within the previous year)
boolean
C0740378 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Injury of body structure | Limb injury | Addison Disease | Myopathy | Injury Affecting Exercise regime Completion | Pharmaceutical Preparation Affecting Exercise regime Completion | Disease Affecting Exercise regime Completion
Item
a recent injury to body or limb, addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
boolean
C0560611 (UMLS CUI [1])
C0743668 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
C0026848 (UMLS CUI [4])
C3263723 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0454291 (UMLS CUI [5,3])
C0205197 (UMLS CUI [5,4])
C0013227 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0454291 (UMLS CUI [6,3])
C0205197 (UMLS CUI [6,4])
C0012634 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0454291 (UMLS CUI [7,3])
C0205197 (UMLS CUI [7,4])
Asthma Treated
Item
asthma which has been medically treated within the last year
boolean
C0004096 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
Glucocorticoids Administration Route Any
Item
current use of glucocorticoid medication (by any route of administration)
boolean
C0017710 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Adrenergic beta-1 Receptor Antagonist
Item
current use of a beta blocker medication
boolean
C0304516 (UMLS CUI [1])
Pseudoephedrine
Item
use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
boolean
C0033798 (UMLS CUI [1])
Hypoglycemia Severe Resulting in Seizure | Hypoglycemia Severe Resulting in Unconscious State | Hypoglycemia Episode Severe
Item
severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0036572 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332294 (UMLS CUI [2,3])
C0041657 (UMLS CUI [2,4])
C0020615 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
Communicable Disease
Item
active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred)
boolean
C0009450 (UMLS CUI [1])
Exercise regime Change Anticipated | Sports Started | Sports stopped
Item
anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport)
boolean
C0454291 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0038039 (UMLS CUI [2,1])
C1272689 (UMLS CUI [2,2])
C0038039 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
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