Hypoglycaemic episode Severe Quantity | Chronic Kidney Failure Moderate | Glomerular Filtration Rate | Loss of hypoglycemic warning | Diabetes Mellitus Duration | Episode of Hypoglycemia | Symptoms Hypoglycemia | Episode Glucose low
Item
subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypo episode within the last year (according to the ada (american diabetes association) definition, april 2013) b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m^2 per ckd-epi (chronic kidney disease epidemiology collaboration) c) hypoglycaemic symptom unawareness d) diabetes mellitus duration for more than 15 years e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl [below or equal to 3.9 mmol/l])) within the last 12 weeks prior to visit 1 (screening)
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
C0342317 (UMLS CUI [4])
C0011849 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C0332189 (UMLS CUI [6,1])
C0020615 (UMLS CUI [6,2])
C1457887 (UMLS CUI [7,1])
C0020615 (UMLS CUI [7,2])
C0332189 (UMLS CUI [8,1])
C0860801 (UMLS CUI [8,2])
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to visit 1
boolean
C0011854 (UMLS CUI [1])
Basal insulin Bolus | Insulin, isophane | Insulin detemir | Short-Acting Insulin Mealtime | Continuous subcutaneous infusion of insulin | Insulin, Short-Acting
Item
current treatment with a basal-bolus regimen consisting of neutral protamine hagedorn (nph) insulin od (once daily) / bid (twice daily) or insulin detemir (idet) od / bid plus 2-4 daily injections of any rapid acting meal time insulin or csii (with rapid acting insulin) for at least 26 weeks prior to visit 1
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0021658 (UMLS CUI [2])
C0537270 (UMLS CUI [3])
C0356365 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0393124 (UMLS CUI [5])
C0356365 (UMLS CUI [6])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin Glargine | Insulin degludec
Item
treatment with iglar or ideg within the last 26 weeks prior to visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening)
boolean
C0907402 (UMLS CUI [1])
C3491971 (UMLS CUI [2])
Antidiabetics | Exception Inclusion criteria
Item
use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])