ID

42896

Beschrijving

Continuous Glucose Monitoring in Youth With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02293577

Link

https://clinicaltrials.gov/show/NCT02293577

Trefwoorden

Versies (2)
  1. 22-07-19 22-07-19 -
  2. 17-09-21 17-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02293577

Engels

Eligibility Type 2 Diabetes NCT02293577

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
duration of type 2 diabetes ≥ 3 months
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
naïve to continuous glucose monitoring
Beschrijving

Continuous glucose monitoring Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4523945
UMLS CUI [1,2]
C0332197
willing to wear a continuous glucose monitor for 5 days
Beschrijving

Use of Blood glucose monitor Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1820407
UMLS CUI [1,3]
C0549178
willing to check blood sugar at least every 12 hours, preferably 3 times a day
Beschrijving

Blood Glucose Check Frequency | Blood Glucose Check times/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005802
UMLS CUI [1,2]
C1283174
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0005802
UMLS CUI [2,2]
C1283174
UMLS CUI [2,3]
C0439511
willing to wear an accelerometer for 5 days
Beschrijving

Use of Accelerometer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0178951
willing to keep a food record for 5 days, including frequent phone contact from the research staff
Beschrijving

Food Record Completion | Phone Contact Research Personnel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C0034869
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0039457
UMLS CUI [2,2]
C0332158
UMLS CUI [2,3]
C0035173
be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
Beschrijving

General health good | Comorbidity Absent | Chronic disease Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0332197
able to give informed consent (for children <18 years, permission from parents and subject assent will be required)
Beschrijving

Informed Consent | Children Age | Informed Consent Parent | Assent Study Subject

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0008059
UMLS CUI [2,2]
C0001779
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C1879749
UMLS CUI [4,2]
C0681850
female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
Beschrijving

Childbearing Potential Sexual Abstinence | Childbearing Potential Family planning/oral contraceptive

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0497432
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
Beschrijving

Disease Interferes with Patient safety | Mental disorder Interferes with Patient safety | Disease Interferes with Completion of clinical trial | Mental disorder Interferes with Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2732579
use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
Beschrijving

Pharmaceutical Preparations Effect Blood glucose level | Exception Insulin | Exception Metformin | Glucocorticoid therapy Oral | Glucocorticoids, Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0392201
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C0744425
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C3540777
subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
Beschrijving

Herbal Supplements

Datatype

boolean

Alias
UMLS CUI [1]
C1504473
history of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
Beschrijving

Hypoglycemic seizures | Hypoglycemia Frequent

Datatype

boolean

Alias
UMLS CUI [1]
C0877056
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0332183
female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Beschrijving

Gender | Pregnancy | Breast Feeding | Pregnancy Tests Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0032976
UMLS CUI [4,2]
C0558080
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Similar models

Eligibility Type 2 Diabetes NCT02293577

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
duration of type 2 diabetes ≥ 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Continuous glucose monitoring Absent
Item
naïve to continuous glucose monitoring
boolean
C4523945 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Use of Blood glucose monitor Continuous
Item
willing to wear a continuous glucose monitor for 5 days
boolean
C1524063 (UMLS CUI [1,1])
C1820407 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Blood Glucose Check Frequency | Blood Glucose Check times/day
Item
willing to check blood sugar at least every 12 hours, preferably 3 times a day
boolean
C0005802 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0005802 (UMLS CUI [2,1])
C1283174 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
Use of Accelerometer
Item
willing to wear an accelerometer for 5 days
boolean
C1524063 (UMLS CUI [1,1])
C0178951 (UMLS CUI [1,2])
Food Record Completion | Phone Contact Research Personnel
Item
willing to keep a food record for 5 days, including frequent phone contact from the research staff
boolean
C0016452 (UMLS CUI [1,1])
C0034869 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0039457 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
General health good | Comorbidity Absent | Chronic disease Absent
Item
be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
boolean
C1277245 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent | Children Age | Informed Consent Parent | Assent Study Subject
Item
able to give informed consent (for children <18 years, permission from parents and subject assent will be required)
boolean
C0021430 (UMLS CUI [1])
C0008059 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C1879749 (UMLS CUI [4,1])
C0681850 (UMLS CUI [4,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Family planning/oral contraceptive
Item
female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0497432 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Disease Interferes with Patient safety | Mental disorder Interferes with Patient safety | Disease Interferes with Completion of clinical trial | Mental disorder Interferes with Completion of clinical trial
Item
presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Pharmaceutical Preparations Effect Blood glucose level | Exception Insulin | Exception Metformin | Glucocorticoid therapy Oral | Glucocorticoids, Systemic
Item
use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C0744425 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C3540777 (UMLS CUI [5])
Herbal Supplements
Item
subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
boolean
C1504473 (UMLS CUI [1])
Hypoglycemic seizures | Hypoglycemia Frequent
Item
history of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
boolean
C0877056 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
Gender | Pregnancy | Breast Feeding | Pregnancy Tests Unwilling
Item
female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032976 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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