ID

12212

Beskrivning

The Inova Type 2 Diabetes Mellitus Study; ODM derived from: https://clinicaltrials.gov/show/NCT02222623

Länk

https://clinicaltrials.gov/show/NCT02222623

Nyckelord

  1. 2015-10-18 2015-10-18 -
Uppladdad den

18 oktober 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes, Type 2 NCT02222623

Eligibility Diabetes, Type 2 NCT02222623

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult patients ages18-75 admitted to a general medicine or surgical department of medicine hospitalist services.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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).
Beskrivning

Diabetes Mellitus Type 2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441730
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).
Beskrivning

Blood Glucose

Datatyp

boolean

Alias
UMLS CUI [1]
C0005802
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a diagnosis of type 1 diabetes mellitus.
Beskrivning

diabetes mellitus type 1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441729
2. patients using nutritional bolus insulin at home.
Beskrivning

insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
3. patients with increased blood glucose concentration, but without a known history of diabetes.
Beskrivning

Blood glucose concentration

Datatyp

boolean

Alias
UMLS CUI [1]
C2585282
4. patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
Beskrivning

Diabetic Ketoacidosis; hyperglycemic hyperosmolar nonketotic syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C1504377
5. patients admitted to or expected to require admission to any intensive care unit (icu) or intermediate care unit (imc).
Beskrivning

intensive care unit

Datatyp

boolean

Alias
UMLS CUI [1]
C0021708
6. patients who are receiving or are anticipated to receive enteral or parenteral nutrition.
Beskrivning

parenteral nutrition

Datatyp

boolean

Alias
UMLS CUI [1]
C0030547
7. patients admitted for cardiac surgery.
Beskrivning

cardiac surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0018821
8. patients receiving continuous insulin infusion.
Beskrivning

Administration of insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0199782
9. patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
Beskrivning

Liver diseases; Steroid therapy; Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0149783
UMLS CUI [3]
C1565489
10. persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).
Beskrivning

Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
11. female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.
Beskrivning

pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
12. patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
Beskrivning

Endocrine System Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0014130

Similar models

Eligibility Diabetes, Type 2 NCT02222623

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])

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