ID

12870

Description

Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00942318

Link

https://clinicaltrials.gov/show/NCT00942318

Keywords

  1. 1/4/16 1/4/16 -
Uploaded on

January 4, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00942318

Eligibility Type 2 Diabetes Mellitus NCT00942318

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Description

diabetes mellitus type 2

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441730
age > 18 years
Description

ID.2

Data type

boolean

patients treated for at least 6 months by multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection-glargine or detemir- or at least 2 nph insulin injections) plus mealtimes rapid acting insulin injections (human or analogs) +/- oral hypoglycemic agents.
Description

long acting insulin; rapid acting insulin

Data type

boolean

Alias
UMLS CUI [1]
C0304870
UMLS CUI [2]
C0356365
7,5% ≤ hba1c ≤ 10%
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
patients able to perform self-monitoring blood glucose (smbg) measurement and insulin injections.
Description

Blood Glucose Self-Monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0005803
smbg > 3/day
Description

Blood Glucose Self-Monitoring

Data type

boolean

Alias
UMLS CUI [1]
C0005803
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetic retinopathy contraindicating glycemic control intensification
Description

diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0011884
situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency…)
Description

Comorbidity Limited Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, …)
Description

Comorbidity Limited Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
recent (<3 month) serious pathology
Description

pathology

Data type

boolean

Alias
UMLS CUI [1]
C0030664
planned treatment or therapy able to induce long-term glycemic control worsening
Description

Poor glycemic control

Data type

boolean

Alias
UMLS CUI [1]
C0342299
long lasting (> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
Description

glucocorticoids; octreotide

Data type

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2]
C0028833
pregnancy wish or ongoing pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
known haemoglobinopathy.
Description

haemoglobinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0019045
creatinin clearance <30ml/min (mdrd formula).
Description

creatinin clearance

Data type

boolean

Alias
UMLS CUI [1]
C0201976
organ transplant.
Description

organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0029216

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00942318

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus type 2
Item
type 2 diabetes mellitus
boolean
C0011849 (UMLS CUI [1,1])
C0441730 (UMLS CUI [1,2])
ID.2
Item
age > 18 years
boolean
long acting insulin; rapid acting insulin
Item
patients treated for at least 6 months by multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection-glargine or detemir- or at least 2 nph insulin injections) plus mealtimes rapid acting insulin injections (human or analogs) +/- oral hypoglycemic agents.
boolean
C0304870 (UMLS CUI [1])
C0356365 (UMLS CUI [2])
hba1c
Item
7,5% ≤ hba1c ≤ 10%
boolean
C0019018 (UMLS CUI [1])
Blood Glucose Self-Monitoring
Item
patients able to perform self-monitoring blood glucose (smbg) measurement and insulin injections.
boolean
C0005803 (UMLS CUI [1])
Blood Glucose Self-Monitoring
Item
smbg > 3/day
boolean
C0005803 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
diabetic retinopathy
Item
diabetic retinopathy contraindicating glycemic control intensification
boolean
C0011884 (UMLS CUI [1])
Comorbidity Limited Compliance behavior
Item
situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency…)
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Comorbidity Limited Compliance behavior
Item
situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, …)
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
pathology
Item
recent (<3 month) serious pathology
boolean
C0030664 (UMLS CUI [1])
Poor glycemic control
Item
planned treatment or therapy able to induce long-term glycemic control worsening
boolean
C0342299 (UMLS CUI [1])
glucocorticoids; octreotide
Item
long lasting (> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
boolean
C0017710 (UMLS CUI [1])
C0028833 (UMLS CUI [2])
pregnancy
Item
pregnancy wish or ongoing pregnancy
boolean
C0549206 (UMLS CUI [1])
haemoglobinopathy
Item
known haemoglobinopathy.
boolean
C0019045 (UMLS CUI [1])
creatinin clearance
Item
creatinin clearance <30ml/min (mdrd formula).
boolean
C0201976 (UMLS CUI [1])
organ transplant
Item
organ transplant.
boolean
C0029216 (UMLS CUI [1])

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