ID

32654

Descrizione

Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01104142

collegamento

https://clinicaltrials.gov/show/NCT01104142

Keywords

versioni (1)
  1. 09/11/18 09/11/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

9 novembre 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT01104142

Inglese

Eligibility Type 1 Diabetes Mellitus NCT01104142

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 to 70 years;
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. have been diagnosed with type 1 diabetes at least 3 years;
Descrizione

Insulin-Dependent Diabetes Mellitus Disease length

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
3. have been treated on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy for at last 6 months;
Descrizione

Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0393124
4. willing not to switch method of insulin delivery (i.e., mdi to csii, or csii to mdi) while enrolled in this study;
Descrizione

Administration of insulin Method unchanged

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0025663
UMLS CUI [1,3]
C0442739
5. baseline a1c within 6.5% to 10.0% (may be determined by poc measurement, e.g., dca 2000 to assess this inclusion criterion);
Descrizione

Hemoglobin A1c measurement | HbA1c Point-of-Care Testing

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0019018
UMLS CUI [2,2]
C1319069
6. patients on mdi should be on a stable dose of peak-less insulin (e.g., lantus) once or twice a day along with any rapid acting prandial insulin analog (e.g., humalog, novolog, or apidra);
Descrizione

Insulin injection Multiple Daily | Insulin Dose Stable | Lantus Dose Stable | Insulin, Short-Acting | Humalog | NovoLog | Apidra

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0876064
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C0356365
UMLS CUI [5]
C0528249
UMLS CUI [6]
C0939412
UMLS CUI [7]
C1654827
7. willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
Descrizione

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

Tipo di dati

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
8. willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear;
Descrizione

Use of Blood glucose meters | Blood Glucose Self-Monitoring

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0472226
UMLS CUI [2]
C0005803
9. willing to take a minimum of 4 fingersticks per day during home use (2 for calibration purposes, 2 for comparative purposes);
Descrizione

Fingerstick Quantity per day Home environment | Fingerstick Quantity Calibration | Fingerstick Quantity Comparison

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2022094
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439505
UMLS CUI [1,4]
C0442519
UMLS CUI [2,1]
C2022094
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0006751
UMLS CUI [3,1]
C2022094
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1707455
10. willing to refrain from the use of acetaminophen during the sensor insertion period and for at least 24-hours prior to sensor insertion;
Descrizione

Avoidance Acetaminophen

Tipo di dati

boolean

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

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

Tipo di dati

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
12. able to speak, read, and write english.
Descrizione

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

Tipo di dati

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
Descrizione

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; 2. subjects who have a known allergy to medical-grade adhesives; 3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion or are planning to become pregnant during the course of study; 4. have a hematocrit that is less than 30%, or greater than 55%; 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); 6. have used cgm for 6 or more weeks (combined) during the 3 months prior to enrollment; 7. 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).
Descrizione

Skin changes Extensive Preventing Sensor | Dermatologic disorders Extensive Preventing Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoos Extensive | Dermatitis Herpetiformis | Allergy to adhesive | Pregnancy | Pregnancy test positive | Pregnancy, Planned | Hematocrit level | Study Subject Participation Status | Investigational New Drugs | Continuous glucose monitoring | Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C

Tipo di dati

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
UMLS CUI [10]
C1635164
UMLS CUI [11]
C0032961
UMLS CUI [12]
C0240802
UMLS CUI [13]
C0032992
UMLS CUI [14]
C0518014
UMLS CUI [15]
C2348568
UMLS CUI [16]
C0013230
UMLS CUI [17]
C4523945
UMLS CUI [18,1]
C0348080
UMLS CUI [18,2]
C0521102
UMLS CUI [18,3]
C2348568
UMLS CUI [19,1]
C0348080
UMLS CUI [19,2]
C1444641
UMLS CUI [19,3]
C0190979
UMLS CUI [20]
C0019163
UMLS CUI [21]
C0019196
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT01104142

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 to 70 years;
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
2. have been diagnosed with type 1 diabetes at least 3 years;
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
3. have been treated on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy for at last 6 months;
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Administration of insulin Method unchanged
Item
4. willing not to switch method of insulin delivery (i.e., mdi to csii, or csii to mdi) while enrolled in this study;
boolean
C0199782 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Hemoglobin A1c measurement | HbA1c Point-of-Care Testing
Item
5. baseline a1c within 6.5% to 10.0% (may be determined by poc measurement, e.g., dca 2000 to assess this inclusion criterion);
boolean
C0474680 (UMLS CUI [1])
C0019018 (UMLS CUI [2,1])
C1319069 (UMLS CUI [2,2])
Insulin injection Multiple Daily | Insulin Dose Stable | Lantus Dose Stable | Insulin, Short-Acting | Humalog | NovoLog | Apidra
Item
6. patients on mdi should be on a stable dose of peak-less insulin (e.g., lantus) once or twice a day along with any rapid acting prandial insulin analog (e.g., humalog, novolog, or apidra);
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0876064 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0356365 (UMLS CUI [4])
C0528249 (UMLS CUI [5])
C0939412 (UMLS CUI [6])
C1654827 (UMLS CUI [7])
Absence Insulin injection Sensor Site | Absence Insulin Pump Administration Set Sensor Site
Item
7. willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
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])
Use of Blood glucose meters | Blood Glucose Self-Monitoring
Item
8. willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear;
boolean
C1524063 (UMLS CUI [1,1])
C0472226 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
Fingerstick Quantity per day Home environment | Fingerstick Quantity Calibration | Fingerstick Quantity Comparison
Item
9. willing to take a minimum of 4 fingersticks per day during home use (2 for calibration purposes, 2 for comparative purposes);
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0442519 (UMLS CUI [1,4])
C2022094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0006751 (UMLS CUI [2,3])
C2022094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1707455 (UMLS CUI [3,3])
Avoidance Acetaminophen
Item
10. 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])
Schedule MRI scan Absent | Schedule CT scan Absent | Schedule X-ray Absent
Item
11. willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or 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
12. 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 | Allergy to adhesive | Pregnancy | Pregnancy test positive | Pregnancy, Planned | Hematocrit level | Study Subject Participation Status | Investigational New Drugs | Continuous glucose monitoring | Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C
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; 2. subjects who have a known allergy to medical-grade adhesives; 3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion or are planning to become pregnant during the course of study; 4. have a hematocrit that is less than 30%, or greater than 55%; 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); 6. have used cgm for 6 or more weeks (combined) during the 3 months prior to enrollment; 7. 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
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])
C1635164 (UMLS CUI [10])
C0032961 (UMLS CUI [11])
C0240802 (UMLS CUI [12])
C0032992 (UMLS CUI [13])
C0518014 (UMLS CUI [14])
C2348568 (UMLS CUI [15])
C0013230 (UMLS CUI [16])
C4523945 (UMLS CUI [17])
C0348080 (UMLS CUI [18,1])
C0521102 (UMLS CUI [18,2])
C2348568 (UMLS CUI [18,3])
C0348080 (UMLS CUI [19,1])
C1444641 (UMLS CUI [19,2])
C0190979 (UMLS CUI [19,3])
C0019163 (UMLS CUI [20])
C0019196 (UMLS CUI [21])
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