Informatie:
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ID
12212
Beschrijving
The Inova Type 2 Diabetes Mellitus Study; ODM derived from: https://clinicaltrials.gov/show/NCT02222623
Link
https://clinicaltrials.gov/show/NCT02222623
Trefwoorden
Versies (1)
- 18-10-15 18-10-15 -
Geüploaded op
18 oktober 2015
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Diabetes, Type 2 NCT02222623
Eligibility Diabetes, Type 2 NCT02222623
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes, Type 2 NCT02222623
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
age
Item
1. adult patients ages18-75 admitted to a general medicine or surgical department of medicine hospitalist services.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Type 2
Item
2. a known history of t2dm, receiving either diet alone, low dose insulin (≤0.4 units/kg/day), oads, glp1 analogs, or in any combination of oads, glp1 analogs and low dose insulin (≤0.4 units/kg/day).
boolean
C0011849 (UMLS CUI [1,1])
C0441730 (UMLS CUI [1,2])
C0441730 (UMLS CUI [1,2])
Blood Glucose
Item
3. subjects must have a bg >140 mg/dl and ≤240 mg/dl before randomization without laboratory evidence of diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome (bicarbonate <18 meq/l, ph <7.30, or positive serum or urinary ketones, bg >240 mg/dl).
boolean
C0005802 (UMLS CUI [1])
diabetes mellitus type 1
Item
1. patients with a diagnosis of type 1 diabetes mellitus.
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
C0441729 (UMLS CUI [1,2])
insulin
Item
2. patients using nutritional bolus insulin at home.
boolean
C0021641 (UMLS CUI [1])
Blood glucose concentration
Item
3. patients with increased blood glucose concentration, but without a known history of diabetes.
boolean
C2585282 (UMLS CUI [1])
Diabetic Ketoacidosis; hyperglycemic hyperosmolar nonketotic syndrome
Item
4. patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
boolean
C0011880 (UMLS CUI [1])
C1504377 (UMLS CUI [2])
C1504377 (UMLS CUI [2])
intensive care unit
Item
5. patients admitted to or expected to require admission to any intensive care unit (icu) or intermediate care unit (imc).
boolean
C0021708 (UMLS CUI [1])
parenteral nutrition
Item
6. patients who are receiving or are anticipated to receive enteral or parenteral nutrition.
boolean
C0030547 (UMLS CUI [1])
cardiac surgery
Item
7. patients admitted for cardiac surgery.
boolean
C0018821 (UMLS CUI [1])
Administration of insulin
Item
8. patients receiving continuous insulin infusion.
boolean
C0199782 (UMLS CUI [1])
Liver diseases; Steroid therapy; Renal Insufficiency
Item
9. patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
boolean
C0023895 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0149783 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Mental disorders
Item
10. persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).
boolean
C0004936 (UMLS CUI [1])
pregnant
Item
11. female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.
boolean
C0549206 (UMLS CUI [1])
Endocrine System Diseases
Item
12. patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
boolean
C0014130 (UMLS CUI [1])