ID

32649

Descripción

Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM); ODM derived from: https://clinicaltrials.gov/show/NCT00939289

Link

https://clinicaltrials.gov/show/NCT00939289

Palabras clave

Versiones (1)
  1. 9/11/18 9/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00939289

Inglés

Eligibility Type 1 Diabetes Mellitus NCT00939289

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older;
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. have been diagnosed with type 1 diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy;
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0439064
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0393124
3. willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either sensor site;
Descripción

Absence Insulin injection Sensor Site | Absence Insulin Pump Administration Set Sensor Site

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0199782
UMLS CUI [1,3]
C0872382
UMLS CUI [1,4]
C0205145
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0181365
UMLS CUI [2,3]
C0872382
UMLS CUI [2,4]
C0205145
4. willing to participate in an 8-hour in-clinic session on study days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
Descripción

Participation Clinic Session | Fingerstick Quantity per hour | Blood draw Quantity per hour

Tipo de datos

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 [2,3]
C0564385
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0564385
5. willing to take a minimum of 6 fingersticks per day during home use;
Descripción

Fingerstick Quantity per day Home environment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2022094
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439505
UMLS CUI [1,4]
C0442519
6. willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
Descripción

Avoidance Acetaminophen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0000970
7. willing not to schedule an magnetic resonance (mri) scan, computed tomography (ct) scan, x-ray, for the duration of the study;
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030703
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0030703
UMLS CUI [2,2]
C0040405
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0030703
UMLS CUI [3,2]
C0034571
UMLS CUI [3,3]
C0332197
8. able to speak, read, and write english.
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. 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;
Descripción

Skin changes Extensive Preventing Sensor | Dermatologic disorders Extensive Preventing Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoos Extensive | Dermatitis Herpetiformis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1399787
UMLS CUI [1,2]
C0205231
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0872382
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0872382
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
2. subjects who have a known allergy to medical-grade adhesives;
Descripción

Allergy to adhesive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1635164
3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
Descripción

Pregnancy | Pregnancy test positive

Tipo de datos

boolean

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

Hematocrit level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518014
5. 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);
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
6. 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).
Descripción

Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C

Tipo de datos

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]
C1444641
UMLS CUI [2,3]
C0190979
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00939289

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
2. have been diagnosed with type 1 diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy;
boolean
C0011854 (UMLS CUI [1])
C0199782 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0393124 (UMLS CUI [3])
Absence Insulin injection Sensor Site | Absence Insulin Pump Administration Set Sensor Site
Item
3. willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either sensor site;
boolean
C0332197 (UMLS CUI [1,1])
C0199782 (UMLS CUI [1,2])
C0872382 (UMLS CUI [1,3])
C0205145 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0181365 (UMLS CUI [2,2])
C0872382 (UMLS CUI [2,3])
C0205145 (UMLS CUI [2,4])
Participation Clinic Session | Fingerstick Quantity per hour | Blood draw Quantity per hour
Item
4. willing to participate in an 8-hour in-clinic session on study days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
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])
C0564385 (UMLS CUI [2,3])
C0005834 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0564385 (UMLS CUI [3,3])
Fingerstick Quantity per day Home environment
Item
5. willing to take a minimum of 6 fingersticks per day during home use;
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0442519 (UMLS CUI [1,4])
Avoidance Acetaminophen
Item
6. willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
boolean
C0870186 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
Schedule MRI scan Absent | Schedule CT scan Absent | Schedule X-ray Absent
Item
7. willing not to schedule an magnetic resonance (mri) scan, computed tomography (ct) scan, x-ray, for the duration of the study;
boolean
C0030703 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0030703 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0030703 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
8. 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 changes Extensive Preventing Sensor | Dermatologic disorders Extensive Preventing Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoos Extensive | Dermatitis Herpetiformis
Item
1. 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])
C0205231 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0872382 (UMLS CUI [1,4])
C0037274 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0872382 (UMLS CUI [2,4])
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])
Allergy to adhesive
Item
2. subjects who have a known allergy to medical-grade adhesives;
boolean
C1635164 (UMLS CUI [1])
Pregnancy | Pregnancy test positive
Item
3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Hematocrit level
Item
4. have a hematocrit that is less than 30%, or greater than 55%;
boolean
C0518014 (UMLS CUI [1])
Study Subject Participation Status
Item
5. 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])
Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C
Item
6. 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])
C1444641 (UMLS CUI [2,2])
C0190979 (UMLS CUI [2,3])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
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