ID

34581

Description

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp; ODM derived from: https://clinicaltrials.gov/show/NCT02189694

Link

https://clinicaltrials.gov/show/NCT02189694

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 1 Diabetes NCT02189694

Eligibility Type 1 Diabetes NCT02189694

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females between the 8 and 17 years of old.
Description

ID.1

Data type

boolean

clinical diagnosis of type 1 diabetes for at least one year. the subject will have been on insulin pump therapy for at least 3 months.
Description

ID.2

Data type

boolean

hba1c ≤ 11.0%.
Description

ID.3

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Description

ID.4

Data type

boolean

severe hypoglycemic episode within two weeks of inclusion in the study. a severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
Description

ID.5

Data type

boolean

current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). stable doses of inhaled steroids are acceptable.
Description

ID.6

Data type

boolean

known or suspected allergy to the trial products.
Description

ID.7

Data type

boolean

other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Description

ID.8

Data type

boolean

failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).
Description

ID.9

Data type

boolean

Similar models

Eligibility Type 1 Diabetes NCT02189694

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
males or females between the 8 and 17 years of old.
boolean
ID.2
Item
clinical diagnosis of type 1 diabetes for at least one year. the subject will have been on insulin pump therapy for at least 3 months.
boolean
ID.3
Item
hba1c ≤ 11.0%.
boolean
Item Group
C0680251 (UMLS CUI)
ID.4
Item
clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
boolean
ID.5
Item
severe hypoglycemic episode within two weeks of inclusion in the study. a severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
boolean
ID.6
Item
current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). stable doses of inhaled steroids are acceptable.
boolean
ID.7
Item
known or suspected allergy to the trial products.
boolean
ID.8
Item
other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
boolean
ID.9
Item
failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).
boolean

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