ID

42785

Description

Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System; ODM derived from: https://clinicaltrials.gov/show/NCT00722241

Lien

https://clinicaltrials.gov/show/NCT00722241

Mots-clés

Versions (2)
  1. 22/02/2018 22/02/2018 -
  2. 17/09/2021 17/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

17 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00722241

Anglais

Eligibility Diabetes Mellitus, Type 1 NCT00722241

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy
Description

Diabetes Mellitus, Insulin-Dependent | Insulin regime Injection Multiple Daily | Insulin regime Continuous subcutaneous infusion of insulin

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C0439064
UMLS CUI [2,4]
C0332173
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0393124
willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear
Description

Injection of insulin Absent | Infusion set for insulin pump Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C2242090
UMLS CUI [2,2]
C0332197
willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear
Description

Blood glucose meter | Blood Glucose Self-Monitoring

Type de données

boolean

Alias
UMLS CUI [1]
C0472226
UMLS CUI [2]
C0005803
willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration
Description

Participation Clinic Session | Blood glucose determination by fingerstick Quantity | Blood draw Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C1883016
UMLS CUI [2,1]
C2022094
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C1265611
willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes)
Description

Blood glucose determination by fingerstick Quantity Home

Type de données

boolean

Alias
UMLS CUI [1,1]
C2022094
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0442519
willing to refrain from the use of acetaminophen during the sensor insertion period and for at least 24-hours prior to sensor insertion
Description

Avoidance Acetaminophen

Type de données

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0000970
willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or x-ray, for the duration of the study
Description

MRI Scan Absent | CT scan Absent | X-ray Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0917711
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0034571
UMLS CUI [3,2]
C0332197
able to speak, read, and write english
Description

Able to speak English Language | Able to read English Language | Able to write English Language

Type de données

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have extensive skin changes/diseases that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
Description

Skin change Excludes Sensor | Dermatologic disorders Exclude Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoo Extensive | Dermatitis Herpetiformis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1399787
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0183210
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0183210
UMLS CUI [3,1]
C0033860
UMLS CUI [3,2]
C0205231
UMLS CUI [4]
C0006434
UMLS CUI [5,1]
C0038814
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0013595
UMLS CUI [6,2]
C0205231
UMLS CUI [7,1]
C0008767
UMLS CUI [7,2]
C0205231
UMLS CUI [8,1]
C1366940
UMLS CUI [8,2]
C0205231
UMLS CUI [9]
C0011608
subjects who have a known allergy to medical-grade adhesives
Description

Hypersensitivity Adhesive Medical

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001516
UMLS CUI [1,3]
C0205476
are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion
Description

Pregnancy Pregnancy test positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0240802
have a hematocrit that is less than 30%, or greater than 55%
Description

Hematocrit level

Type de données

boolean

Alias
UMLS CUI [1]
C0518014
current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study)
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
have any condition that, in the opinion of the investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c)
Description

Condition Interferes with Study Subject Participation Status | Condition High risk Venous blood sample Handling | Hepatitis B | Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C0444255
UMLS CUI [2,4]
C0037793
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00722241

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin regime Injection Multiple Daily | Insulin regime Continuous subcutaneous infusion of insulin
Item
have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy
boolean
C0011854 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
C0557978 (UMLS CUI [3,1])
C0393124 (UMLS CUI [3,2])
Injection of insulin Absent | Infusion set for insulin pump Absent
Item
willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear
boolean
C0199782 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2242090 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Blood glucose meter | Blood Glucose Self-Monitoring
Item
willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear
boolean
C0472226 (UMLS CUI [1])
C0005803 (UMLS CUI [2])
Participation Clinic Session | Blood glucose determination by fingerstick Quantity | Blood draw Quantity
Item
willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration
boolean
C0679823 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C1883016 (UMLS CUI [1,3])
C2022094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Blood glucose determination by fingerstick Quantity Home
Item
willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes)
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0442519 (UMLS CUI [1,3])
Avoidance Acetaminophen
Item
willing to refrain from the use of acetaminophen during the sensor insertion period and for at least 24-hours prior to sensor insertion
boolean
C0870186 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
MRI Scan Absent | CT scan Absent | X-ray Absent
Item
willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or x-ray, for the duration of the study
boolean
C0917711 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0034571 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
able to speak, read, and write english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Skin change Excludes Sensor | Dermatologic disorders Exclude Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoo Extensive | Dermatitis Herpetiformis
Item
have extensive skin changes/diseases that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
boolean
C1399787 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0183210 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0183210 (UMLS CUI [2,3])
C0033860 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0006434 (UMLS CUI [4])
C0038814 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0013595 (UMLS CUI [6,1])
C0205231 (UMLS CUI [6,2])
C0008767 (UMLS CUI [7,1])
C0205231 (UMLS CUI [7,2])
C1366940 (UMLS CUI [8,1])
C0205231 (UMLS CUI [8,2])
C0011608 (UMLS CUI [9])
Hypersensitivity Adhesive Medical
Item
subjects who have a known allergy to medical-grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
Pregnancy Pregnancy test positive
Item
are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Hematocrit level
Item
have a hematocrit that is less than 30%, or greater than 55%
boolean
C0518014 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Interferes with Study Subject Participation Status | Condition High risk Venous blood sample Handling | Hepatitis B | Hepatitis C
Item
have any condition that, in the opinion of the investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c)
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0444255 (UMLS CUI [2,3])
C0037793 (UMLS CUI [2,4])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
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