ID

41176

Description

Metformin Therapy in Type 1 Diabetes Mellitus.; ODM derived from: https://clinicaltrials.gov/show/NCT01889706

Link

https://clinicaltrials.gov/show/NCT01889706

Keywords

Versions (1)
  1. 7/5/20 7/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Loss of Control of Diabetes NCT01889706

English

Eligibility Loss of Control of Diabetes NCT01889706

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years <60 years,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
duration of diabetes >3 years,
Description

Diabetes Mellitus Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0449238
lack of metabolic control- hba1c>7,5% (despite participation in 5-day who education program)
Description

Control Metabolic Lacking | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C2587213
UMLS CUI [1,2]
C0311400
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0474680
treated with intensive insulin therapy
Description

Insulin regime With intensity

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0522510
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metabolically decompensate diabetes with acetonuria,
Description

Decompensated diabetes Metabolic | Ketonuria

Data type

boolean

Alias
UMLS CUI [1,1]
C4324690
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0162275
suspected lack of compliance,
Description

Compliance Lacking Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0750491
lack of glucose and ketones self-monitoring,
Description

Blood Glucose Self-Monitoring Lacking | Self-monitoring of blood ketone Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C3839577
UMLS CUI [2,2]
C0332268
hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
Description

Hypoglycaemia unawareness | Recurrent severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
recurrent diabetic ketoacidosis (more than two episodes in the past year)
Description

Diabetic Ketoacidosis Recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C2945760
another serious medical illness,
Description

Other medical condition Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
pregnancy or sexually active woman unwilling to take birth control.
Description

Pregnancy | Gender Sexually active Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0558080
renal impairment (estimated on the value calculated glomerular filtration rate using the mdrd formula-estimated glomerular filtration rate, egfr<45 ml / min
Description

Renal Insufficiency | GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
liver cell damage alanine aminotransferase (alt), aspartate aminotransferase (ast) greater than twice the upper normal limit),
Description

Liver damage | Alanine Aminotransferase Increased | Aspartate Aminotransferase Increased

Data type

boolean

Alias
UMLS CUI [1]
C0151763
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
history of drug or alcohol abuse or those who used this drug before
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
changes in the way of antihypertensive and antihyperlipemic treatment.
Description

Antihypertensive therapy Change | Hypolipidemic Agents Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0086440
UMLS CUI [2,2]
C0392747
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Similar models

Eligibility Loss of Control of Diabetes NCT01889706

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years <60 years,
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Duration
Item
duration of diabetes >3 years,
boolean
C0011849 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Control Metabolic Lacking | Hemoglobin A1c measurement
Item
lack of metabolic control- hba1c>7,5% (despite participation in 5-day who education program)
boolean
C2587213 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
Insulin regime With intensity
Item
treated with intensive insulin therapy
boolean
C0557978 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Decompensated diabetes Metabolic | Ketonuria
Item
metabolically decompensate diabetes with acetonuria,
boolean
C4324690 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0162275 (UMLS CUI [2])
Compliance Lacking Suspected
Item
suspected lack of compliance,
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Blood Glucose Self-Monitoring Lacking | Self-monitoring of blood ketone Lacking
Item
lack of glucose and ketones self-monitoring,
boolean
C0005803 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C3839577 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Hypoglycaemia unawareness | Recurrent severe hypoglycemia
Item
hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Diabetic Ketoacidosis Recurrent
Item
recurrent diabetic ketoacidosis (more than two episodes in the past year)
boolean
C0011880 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Other medical condition Serious
Item
another serious medical illness,
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Gender Sexually active Contraceptive methods Unwilling
Item
pregnancy or sexually active woman unwilling to take birth control.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Renal Insufficiency | GFR estimation by MDRD
Item
renal impairment (estimated on the value calculated glomerular filtration rate using the mdrd formula-estimated glomerular filtration rate, egfr<45 ml / min
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Liver damage | Alanine Aminotransferase Increased | Aspartate Aminotransferase Increased
Item
liver cell damage alanine aminotransferase (alt), aspartate aminotransferase (ast) greater than twice the upper normal limit),
boolean
C0151763 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Substance Use Disorder
Item
history of drug or alcohol abuse or those who used this drug before
boolean
C0038586 (UMLS CUI [1])
Antihypertensive therapy Change | Hypolipidemic Agents Change
Item
changes in the way of antihypertensive and antihyperlipemic treatment.
boolean
C0585941 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0086440 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
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