ID

32649

Beschreibung

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

Stichworte

Versionen (1)
  1. 09.11.18 09.11.18 -
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See clinicaltrials.gov

Hochgeladen am

9. November 2018

DOI

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Eligibility Type 1 Diabetes Mellitus NCT00939289

Englisch

Eligibility Type 1 Diabetes Mellitus NCT00939289

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Fingerstick Quantity per day Home environment

Datentyp

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;
Beschreibung

Avoidance Acetaminophen

Datentyp

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;
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Allergy to adhesive

Datentyp

boolean

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

Pregnancy | Pregnancy test positive

Datentyp

boolean

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

Hematocrit level

Datentyp

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);
Beschreibung

Study Subject Participation Status

Datentyp

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).
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Type 1 Diabetes Mellitus NCT00939289

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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