Age | Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length
Item
1. men and women who have had either type 1 or type 2 diabetes (world health organization[who]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Insulin regime
Item
2. have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
boolean
C0557978 (UMLS CUI [1])
Increased HbA1c levels
Item
3. have an hba1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at visit 1.
boolean
C4073162 (UMLS CUI [1])
Compliance behavior | Diet therapy | Insulin regime | Blood Glucose Self-Monitoring
Item
4. have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
boolean
C1321605 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0557978 (UMLS CUI [3])
C0005803 (UMLS CUI [4])
Informed Consent
Item
5. have given informed consent to participate in this study in accordance with local regulations.
boolean
C0021430 (UMLS CUI [1])
Antidiabetics Oral | Biguanides | Sulfonylurea Compounds | Glucosidase Inhibitor | Enhanced insulin sensitivity
Item
{1] have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0005382 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1512211 (UMLS CUI [4])
C3549878 (UMLS CUI [5])
Insulin Cumulative Dose Unit/kilogram/day
Item
[2] receive a total daily dose of insulin >2 units/kg.
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
Hypoglycemia Severe Episode Quantity | Hypoglycemia Disabling Requirement Assistance
Item
[3] have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C4061999 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1269765 (UMLS CUI [2,4])
Body mass index
Item
[4] have a body mass index >35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Serum creatinine raised
Item
[5] have serum creatinine > the upper limit of normal (uln), as determined by a local laboratory.
boolean
C0700225 (UMLS CUI [1])