ID

32627

Description

Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections; ODM derived from: https://clinicaltrials.gov/show/NCT00542399

Link

https://clinicaltrials.gov/show/NCT00542399

Keywords

Versions (1)
  1. 11/8/18 11/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00542399

English

Eligibility Type 1 Diabetes Mellitus NCT00542399

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent obtained before any trial related activity
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
Description

Children | Diabetes Mellitus, Insulin-Dependent | Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0557978
3. age > 6 years and < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. hba1c > 7.7%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
5. ability and willingness to accept the study conditions and to inject insulin detemir
Description

Protocol Compliance | Insulin detemir Injection

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0537270
UMLS CUI [2,2]
C1828121
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. impaired renal function or current renal dialysis.
Description

Renal Insufficiency | Dialysis procedure

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0011946
2. acute or chronic metabolic acidosis, including diabetic ketoacidosis.
Description

Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
UMLS CUI [3]
C0011880
3. known hypoglycemia unawareness.
Description

Hypoglycemia unawareness.

Data type

boolean

Alias
UMLS CUI [1]
C0342317
4. known or suspected allergy to trial products.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
5. clinical evidence of active liver disease or impaired hepatic function
Description

Liver diseases | Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0086565
6. participation in another study (with study drug) within the last 3 months prior to this trial.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
7. significant concomitant disease likely to interfere with glucose metabolism
Description

Comorbidity Interferes with Glucose metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
8. proven eating disorders
Description

Eating Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0013473
9. malignancy within the last 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
10. history of repeated severe hypoglycemia within the last year.
Description

Hypoglycemia Severe Repeated

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205341
11. known diabetes retinopathy
Description

Diabetic Retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0011884
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00542399

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. informed consent obtained before any trial related activity
boolean
C0021430 (UMLS CUI [1])
Children | Diabetes Mellitus, Insulin-Dependent | Insulin regime
Item
2. children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
boolean
C0008059 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0557978 (UMLS CUI [3])
Age
Item
3. age > 6 years and < 18 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c > 7.7%
boolean
C0474680 (UMLS CUI [1])
Protocol Compliance | Insulin detemir Injection
Item
5. ability and willingness to accept the study conditions and to inject insulin detemir
boolean
C0525058 (UMLS CUI [1])
C0537270 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Dialysis procedure
Item
1. impaired renal function or current renal dialysis.
boolean
C1565489 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis
Item
2. acute or chronic metabolic acidosis, including diabetic ketoacidosis.
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
Hypoglycemia unawareness.
Item
3. known hypoglycemia unawareness.
boolean
C0342317 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
4. known or suspected allergy to trial products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Liver diseases | Liver Dysfunction
Item
5. clinical evidence of active liver disease or impaired hepatic function
boolean
C0023895 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
6. participation in another study (with study drug) within the last 3 months prior to this trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Comorbidity Interferes with Glucose metabolism
Item
7. significant concomitant disease likely to interfere with glucose metabolism
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Eating Disorders
Item
8. proven eating disorders
boolean
C0013473 (UMLS CUI [1])
Malignant Neoplasms
Item
9. malignancy within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Hypoglycemia Severe Repeated
Item
10. history of repeated severe hypoglycemia within the last year.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Diabetic Retinopathy
Item
11. known diabetes retinopathy
boolean
C0011884 (UMLS CUI [1])
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