ID

12212

Description

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

Link

https://clinicaltrials.gov/show/NCT02222623

Keywords

  1. 10/18/15 10/18/15 -
Uploaded on

October 18, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes, Type 2 NCT02222623

Eligibility Diabetes, Type 2 NCT02222623

Inclusion Criteria
Description

Inclusion Criteria

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

age

Data type

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).
Description

Diabetes Mellitus Type 2

Data type

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).
Description

Blood Glucose

Data type

boolean

Alias
UMLS CUI [1]
C0005802
Exclusion Criteria
Description

Exclusion Criteria

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

diabetes mellitus type 1

Data type

boolean

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

insulin

Data type

boolean

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

Blood glucose concentration

Data type

boolean

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

Diabetic Ketoacidosis; hyperglycemic hyperosmolar nonketotic syndrome

Data type

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).
Description

intensive care unit

Data type

boolean

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

parenteral nutrition

Data type

boolean

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

cardiac surgery

Data type

boolean

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

Administration of insulin

Data type

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).
Description

Liver diseases; Steroid therapy; Renal Insufficiency

Data type

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).
Description

Mental disorders

Data type

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.
Description

pregnant

Data type

boolean

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

Endocrine System Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0014130

Similar models

Eligibility Diabetes, Type 2 NCT02222623

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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