ID

23564

Description

Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00590226

Link

https://clinicaltrials.gov/show/NCT00590226

Keywords

Versions (1)
  1. 7/9/17 7/9/17 -
Copyright Holder

Study Chair: David Baldwin, MD Rush University Medical Center

Uploaded on

July 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes NCT00590226

English

Eligibility Type 2 Diabetes NCT00590226

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females between the ages of 18 and 70 years admitted to a general medical service.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. a known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
Description

diabetes mellitus type 2, oral antidiabetics, insulin therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C0557978
3. subjects must have an admission blood glucose > 140 mg and < 400 mg/dl and no evidence of ketoacidosis (serum bicarbonate < 18 meq/l, venous or arterial ph < 7.30, positive serum or urinary ketones).
Description

blood glucose, ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0202042
UMLS CUI [2,1]
C0011880
UMLS CUI [2,2]
C0202059
UMLS CUI [2,3]
C0236489
UMLS CUI [2,4]
C0036812
UMLS CUI [2,5]
C0162275
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with increased blood glucose concentration, but without a known history of diabetes.
Description

increased blood glucose without diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0011849
2. subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63].
Description

hyperglycemic crisis, diabetic ketoacidosis, hyperosmolar hyperglycemic state, ketonuria

Data type

boolean

Alias
UMLS CUI [1,1]
C2711084
UMLS CUI [1,2]
C0011880
UMLS CUI [1,3]
C0745095
UMLS CUI [1,4]
C0162275
3. patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (icu, ccu), or to undergo surgery during the hospitalization course.
Description

acute critical illness, surgery expected

Data type

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1517001
4. patients with clinically relevant hepatic disease (alt 2.5x > upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dl for males, or ≥1.8 mg/dl for females.
Description

liver or kidney disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C0201836
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0201976
5. history of drug or alcohol abuse within the last 2 years.
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
6. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Description

mental condition

Data type

boolean

Alias
UMLS CUI [1]
C3840291
7. patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.
Description

endocrine disorders

Data type

boolean

Alias
UMLS CUI [1]
C0014130
8. female subjects are pregnant or breast feeding at time of enrollment into the study.
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Type 2 Diabetes NCT00590226

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. males or females between the ages of 18 and 70 years admitted to a general medical service.
boolean
C0001779 (UMLS CUI [1])
diabetes mellitus type 2, oral antidiabetics, insulin therapy
Item
2. a known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
boolean
C0011860 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
blood glucose, ketoacidosis
Item
3. subjects must have an admission blood glucose > 140 mg and < 400 mg/dl and no evidence of ketoacidosis (serum bicarbonate < 18 meq/l, venous or arterial ph < 7.30, positive serum or urinary ketones).
boolean
C0202042 (UMLS CUI [1])
C0011880 (UMLS CUI [2,1])
C0202059 (UMLS CUI [2,2])
C0236489 (UMLS CUI [2,3])
C0036812 (UMLS CUI [2,4])
C0162275 (UMLS CUI [2,5])
Item Group
C0680251 (UMLS CUI)
increased blood glucose without diabetes
Item
1. subjects with increased blood glucose concentration, but without a known history of diabetes.
boolean
C0202042 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0011849 (UMLS CUI [1,4])
hyperglycemic crisis, diabetic ketoacidosis, hyperosmolar hyperglycemic state, ketonuria
Item
2. subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63].
boolean
C2711084 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C0745095 (UMLS CUI [1,3])
C0162275 (UMLS CUI [1,4])
acute critical illness, surgery expected
Item
3. patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (icu, ccu), or to undergo surgery during the hospitalization course.
boolean
C0010340 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
liver or kidney disease
Item
4. patients with clinically relevant hepatic disease (alt 2.5x > upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dl for males, or ≥1.8 mg/dl for females.
boolean
C1278039 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0201976 (UMLS CUI [2,2])
substance abuse
Item
5. history of drug or alcohol abuse within the last 2 years.
boolean
C0038586 (UMLS CUI [1])
mental condition
Item
6. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C3840291 (UMLS CUI [1])
endocrine disorders
Item
7. patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.
boolean
C0014130 (UMLS CUI [1])
pregnancy, breast feeding
Item
8. female subjects are pregnant or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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