age at least 13 Years
Item
age at least 13 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
Item
Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
Item
Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
boolean
CL415147 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0586328 (UMLS CUI 2011AA)
308755006 (SNOMED CT 2011_0131)
Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir
Item
Mean total daily insulin dose for 3 days prior to screening <= 46 units/day if using a 300-Unit reservoir or <= 26 units/day if using a 180 unit reservoir
boolean
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C2348070 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1519795 (UMLS CUI 2011AA)
C1289877 (UMLS CUI 2011AA)
Baseline body mass index (BMI) <= 35.0 kg/m2
Item
Baseline body mass index (BMI) <= 35.0 kg/m2
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Baseline HbA1c 5% to 9%
Item
Baseline HbA1c 5% to 9%
boolean
C1442488 (UMLS CUI 2011AA)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
Item
Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
Impaired renal function (serum creatinine >= 2.0 mg/dl)
Item
Impaired renal function (serum creatinine >= 2.0 mg/dl)
boolean
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
Legal blindness
Item
Legal Blindness
boolean
C0271215 (UMLS CUI 2011AA)
65956007 (SNOMED CT 2011_0131)
Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
Item
Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
boolean
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0020617 (UMLS CUI 2011AA)
267384006 (SNOMED CT 2011_0131)
10021000 (MedDRA 14.1)
E15 (ICD-10-CM Version 2010)
251.0 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0233407 (UMLS CUI 2011AA)
62476001 (SNOMED CT 2011_0131)
10013395 (MedDRA 14.1)
MTHU013516 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
Item
Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
boolean
C0342317 (UMLS CUI 2011AA)
10020997 (MedDRA 14.1)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C0005802 (UMLS CUI 2011AA)
Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
Item
Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
boolean
C1546435 (UMLS CUI 2011AA)
ER (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C0726398 (UMLS CUI 2011AA)
Have had a pump-related infusion site abscess in the 12 months prior to screening.
Item
Have had a pump-related infusion site abscess in the 12 months prior to screening.
boolean
C0182537 (UMLS CUI 2011AA)
44668000 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C1142012 (UMLS CUI 2011AA)
10058464 (MedDRA 14.1)
Have had multiple, clinically significant occlusions as judged by the investigator.
Item
Have had multiple, clinically significant occlusions as judged by the investigator.
boolean
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
CL354751 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10029990 (MedDRA 14.1)
Have had any infection with Staph aureus in the past 5 years
Item
Infection due to Staphylococcus aureus
boolean
C1318973 (UMLS CUI 2011AA)
406602003 (SNOMED CT 2011_0131)
Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
Item
Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
boolean
C0243087 (UMLS CUI 2011AA)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C2242489 (UMLS CUI 2011AA)
10067777 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
Item
Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
Item
Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
boolean
C0005841 (UMLS CUI 2011AA)
116859006 (SNOMED CT 2011_0131)
10005835 (MedDRA 14.1)
MTHU020992 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0019045 (UMLS CUI 2011AA)
80141007 (SNOMED CT 2011_0131)
10060892 (MedDRA 14.1)
MTHU029621 (LOINC Version 232)
D58.2 (ICD-10-CM Version 2010)
C0002878 (UMLS CUI 2011AA)
61261009 (SNOMED CT 2011_0131)
10018916 (MedDRA 14.1)
D55-D59 (ICD-10-CM Version 2010)
C0002895 (UMLS CUI 2011AA)
127040003 (SNOMED CT 2011_0131)
10040641 (MedDRA 14.1)
MTHU021603 (LOINC Version 232)
D57.1 (ICD-10-CM Version 2010)
282.6 (ICD-9-CM Version 2011)
C0349705 (UMLS CUI 2011AA)
10018879 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0969625 (UMLS CUI 2011AA)
Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
Item
Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
Have an irregular sleep/wake cycle in the investigator's opinion.
Item
Abnormal sleep-wake cycles
boolean
C1862910 (UMLS CUI 2011AA)
Have a known hypersensitivity or allergy to any of the study insulins or their excipients
Item
Have a known hypersensitivity or allergy to any of the study insulins or their excipients
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Item
Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
boolean
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
Item
Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
boolean
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1096117 (UMLS CUI 2011AA)
10053762 (MedDRA 14.1)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
Item
Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0010995 (UMLS CUI 2011AA)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)