ID

17159

Description

Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children; ODM derived from: https://clinicaltrials.gov/show/NCT00069615

Link

https://clinicaltrials.gov/show/NCT00069615

Keywords

Versions (1)
  1. 8/29/16 8/29/16 -
Uploaded on

August 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

English

Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
duration of diabetes > 1 year
Description

Diabetes disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0872146
daily insulin therapy (pump or at least 2 injections/day)
Description

Insulin regime Daily | Insulin pump | Insulin injection Quantity Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0332173
UMLS CUI [2]
C1140609
UMLS CUI [3,1]
C0199782
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332173
stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)
Description

Insulin regime Stable status | Administration of insulin Modality Change | injection of insulin | Insulin pump

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0695347
UMLS CUI [2,3]
C0392747
UMLS CUI [3]
C0586328
UMLS CUI [4]
C1140609
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
Description

Skin Abnormalities Affecting Protocol Compliance | Disease Significant Affecting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0037268
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0525058
prior use of a gwb prescribed for home use (prior use of a gwb as part of a research study is allowable)
Description

Blood glucose measurement Investigational Medical Device Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C2346570
UMLS CUI [1,3]
C1524063
the presence of any of the following diseases:
Description

Disease Presence

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
asthma if treated with systemic or inhaled corticosteroids in the last 6 months
Description

Asthma | systemic steroids | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2825233
UMLS CUI [3]
C2065041
cystic fibrosis
Description

Cystic Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0010674
other major illness that in the judgment of the investigator might interfere with the completion of the protocol
Description

Illness Major Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
adequately treated thyroid disease and celiac disease do not exclude
Description

Therapeutic procedure Adequate Thyroid Diseases | Therapeutic procedure Adequate Celiac Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0040128
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
UMLS CUI [2,3]
C0007570
inpatient psychiatric treatment in the past 6 months for either the subject or the subject’s primary care giver (i.e., parent or guardian).
Description

inpatient psychiatric therapy | inpatient psychiatric therapy Caregiver Primary | inpatient psychiatric therapy parent | inpatient psychiatric therapy Guardian

Data type

boolean

Alias
UMLS CUI [1]
C2142969
UMLS CUI [2,1]
C2142969
UMLS CUI [2,2]
C0085537
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C2142969
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C2142969
UMLS CUI [4,2]
C1274041
current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Description

Pharmaceutical Preparations Medical contraindication Study Subject Participation Status | Glucocorticoids Oral | Glucocorticoids Inhalation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0205535
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Similar models

Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetes disease length
Item
duration of diabetes > 1 year
boolean
C0011847 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime Daily | Insulin pump | Insulin injection Quantity Daily
Item
daily insulin therapy (pump or at least 2 injections/day)
boolean
C0557978 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C1140609 (UMLS CUI [2])
C0199782 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Insulin regime Stable status | Administration of insulin Modality Change | injection of insulin | Insulin pump
Item
stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0695347 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0586328 (UMLS CUI [3])
C1140609 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Skin Abnormalities Affecting Protocol Compliance | Disease Significant Affecting Protocol Compliance
Item
the presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
boolean
C0037268 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Blood glucose measurement Investigational Medical Device Use of
Item
prior use of a gwb prescribed for home use (prior use of a gwb as part of a research study is allowable)
boolean
C0392201 (UMLS CUI [1,1])
C2346570 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
Disease Presence
Item
the presence of any of the following diseases:
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Asthma | systemic steroids | inhaled steroids
Item
asthma if treated with systemic or inhaled corticosteroids in the last 6 months
boolean
C0004096 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
Cystic Fibrosis
Item
cystic fibrosis
boolean
C0010674 (UMLS CUI [1])
Illness Major Interferes with Protocol Compliance
Item
other major illness that in the judgment of the investigator might interfere with the completion of the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Therapeutic procedure Adequate Thyroid Diseases | Therapeutic procedure Adequate Celiac Disease
Item
adequately treated thyroid disease and celiac disease do not exclude
boolean
C0087111 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0040128 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0007570 (UMLS CUI [2,3])
inpatient psychiatric therapy | inpatient psychiatric therapy Caregiver Primary | inpatient psychiatric therapy parent | inpatient psychiatric therapy Guardian
Item
inpatient psychiatric treatment in the past 6 months for either the subject or the subject’s primary care giver (i.e., parent or guardian).
boolean
C2142969 (UMLS CUI [1])
C2142969 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C2142969 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C2142969 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Pharmaceutical Preparations Medical contraindication Study Subject Participation Status | Glucocorticoids Oral | Glucocorticoids Inhalation
Item
current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
boolean
C0013227 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
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