Diabetes Mellitus, Non-Insulin-Dependent
Item
1. type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Age
Item
2. males and females ≥ 60 years of old.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. body mass index between 27 and 40 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Frailty Absent
Item
4. non fragile defined based on moorhouse et al. scale [23].
boolean
C0424594 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Administration of insulin U/day | Basal insulin Injection Bedtime | Diabetes Therapy
Item
5. using at least 3 insulin injections per day. however, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
boolean
C0199782 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0521112 (UMLS CUI [2,3])
C3274787 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
6. hba1c above 8%.
boolean
C0474680 (UMLS CUI [1])
Kidney Disease Advanced
Item
1. advanced
boolean
C0022658 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Kidney Diseases | Creatinine clearance measurement
Item
1. nephropathy defined by creatinine clearance <30 ml/min.
boolean
C0022658 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Retinal Diseases | Proliferative retinopathy | Eye bleeding | Laser therapy for retinal lesion | Panretinal photocoagulation
Item
2. retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. if the patient have undergone panphoto-coagulation inclusion is acceptable.
boolean
C0035309 (UMLS CUI [1])
C0339467 (UMLS CUI [2])
C0423008 (UMLS CUI [3])
C0438670 (UMLS CUI [4])
C0730064 (UMLS CUI [5])
Autonomic neuropathy | Gastroparesis Clinical Significance
Item
3. autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
boolean
C0259749 (UMLS CUI [1])
C0152020 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Macrovascular disease | Acute Coronary Syndrome | Cardiac Surgery
Item
2. recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
boolean
C2609253 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
Limited Walking Ability caused by Following | Injury of unspecified body region | Limb injury | Myopathy | Pharmaceutical Preparations | Disease Significant
Item
3. a recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
boolean
C2674459 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0496020 (UMLS CUI [2])
C0743668 (UMLS CUI [3])
C0026848 (UMLS CUI [4])
C0013227 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
Communicable Disease needing Intravenous antibiotic therapy | Communicable Disease needing Hospitalization
Item
4. a recent (< 2 months) infection needing iv antibiotic or hospitalization
boolean
C0009450 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Hypoglycaemic episode Severe
Item
5. severe hypoglycemic episode within two weeks of screening.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Glucocorticoids Pharmaceutical Preparations Use | Drug Administration Routes | Glucocorticoids Inhalation Low dose Stable
Item
6. current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
boolean
C0017710 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0013153 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Therapeutic procedure Initiation Interferes with glucose metabolism | Therapeutic procedure Dose Modification Interferes with glucose metabolism | Neuroleptics
Item
7. recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
boolean
C0087111 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0596620 (UMLS CUI [2,4])
C0040615 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Meal Contents
Item
8. known or suspected allergy to the trial products or meal contents.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0456205 (UMLS CUI [2,3])
Illness Serious Interferes with Study Subject Participation Status | Illness Serious Compliance behavior Limited
Item
9. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])