Age
Item
be male or female between the ages 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus ADA Classification | Insulin-Dependent Diabetes Mellitus WHO classification | Insulin-Dependent Diabetes Mellitus Disease length | Insulin injection Dosage Daily
Item
type 1 diabetes mellitus patients (according to ada and/or who classification) who have >1 year history of type 1 dm and are currently managed with daily insulin injections totalling 0.3 to 0.8 iu/kg of body weight;
boolean
C0011854 (UMLS CUI [1,1])
C1705019 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0011854 (UMLS CUI [2,1])
C4267671 (UMLS CUI [2,2])
C0011854 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0199782 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
Abnormality Absent Physical Examination | Abnormality Absent Vital signs | Abnormality Absent Electrocardiography
Item
current physical examination, vital signs and ecg at screening that reveals no clinically significant abnormalities;
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0518766 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
Body mass index
Item
have a body mass index (bmi) <27;
boolean
C1305855 (UMLS CUI [1])
ID.5
Item
8.5% (inclusively)<have a glycosylated haemoglobulin hba1c
boolean
Protocol Compliance Insulin-Dependent Diabetes Mellitus | Blood Glucose Self-Monitoring | Recording Value | Recording Hypoglycemic event
Item
willing and able to follow the american diabetes association diet guidelines for type 1 diabetes; be able to commit to perform home blood glucose monitoring and record values as well as hypoglycemic events
boolean
C0525058 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
C0557070 (UMLS CUI [3,1])
C1522609 (UMLS CUI [3,2])
C0557070 (UMLS CUI [4,1])
C0342312 (UMLS CUI [4,2])
Informed Consent
Item
willing to give written informed consent prior to admission into the study.
boolean
C0021430 (UMLS CUI [1])
Asthma | Buccal mucosa Abnormality Suspected | Cardiovascular Diseases | Cerebrovascular Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Hematological Disease | Autoimmune Diseases | Exception Autoimmune thyroid disease | Atopy | Drug Allergy
Item
have a significant active asthma or suspected abnormalities of buccal mucosa; cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, hematological, or auto-immune disease (other than auto-immune thyroid disease); history of athopy or drugs allergy
boolean
C0004096 (UMLS CUI [1])
C1578559 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0004364 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0178468 (UMLS CUI [10,2])
C0392707 (UMLS CUI [11])
C0013182 (UMLS CUI [12])
Retinal Disease Unstable | Preproliferative retinopathy Requirement Light Coagulation | Proliferative retinopathy Requirement Light Coagulation | Kidney Diseases | Neuropathy | Gastroparesis | Hypotension, Orthostatic
Item
have evidence of unstable retinopathy (defined as pre-proliferative or proliferative retinopathy currently requiring photocoagulation therapy), nephropathy or neuropathy (gastroparesis or orthostatic hypotension);
boolean
C0035309 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0339473 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0023694 (UMLS CUI [2,3])
C0339467 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0023694 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0152020 (UMLS CUI [6])
C0020651 (UMLS CUI [7])
Loss of hypoglycemic warning
Item
have hypoglycemia unawareness;
boolean
C0342317 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity | Seizure | Hypoglycemic coma | Ketoacidosis
Item
have had more than one episode of severe hypoglycemia with seizure or coma or ketoacidosis within the past 12 months;
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0036572 (UMLS CUI [2])
C0020617 (UMLS CUI [3])
C0220982 (UMLS CUI [4])
Blood Pressure Excess
Item
have a blood pressure in excess of 160/100 mmhg at the screening visit;
boolean
C0005823 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
Acute illness
Item
have had any acute illness within the 2 weeks prior to screening;
boolean
C4061114 (UMLS CUI [1])
Substance Use Disorder Interferes with Study Subject Participation Status
Item
have a history of drug or alcohol abuse that in the opinion of the investigator would interfere with participation in the protocol
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])