ID

13693

Descripción

Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis; ODM derived from: https://clinicaltrials.gov/show/NCT01461616

Link

https://clinicaltrials.gov/show/NCT01461616

Palabras clave

Versiones (1)
  1. 28/2/16 28/2/16 -
Subido en

28 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT01461616

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT01461616

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent obtained before any trial-related activities.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosis of diabetes mellitus according to who criteria; history and clinical course consistent with type 1 diabetes mellitus.
Descripción

diabetes mellitus type 1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441729
3. diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (csii) at least 6 months at time of inclusion.
Descripción

continuous subcutaneous insulin infusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393124
4. total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
Descripción

Dosage insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0021641
5. hba1c between 6% and 9% (both values included).
Descripción

hba1c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
6. age ≥ 18 years.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
7. bmi between 18.5 and 28 kg /m2 (including both values).
Descripción

bmi

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known or suspected allergy to trial product(s) or related products.
Descripción

hypersensitivity study drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
2. recurrent major hypoglycaemic episodes.
Descripción

hypoglycaemic episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0745153
3. heart: unstable angina pectoris, ami < 12 months or heart insufficiency classified according to nyha iii-iv
Descripción

unstable angina pectoris; nyha classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C1275491
4. blood pressure: severe uncontrolled hypertension with bp > 180/110 mmhg, sitting
Descripción

blood pressure; uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C1868885
5. liver: impaired hepatic function corresponding to serum-alat or basic phosphatase > 2 x upper reference limit of the local laboratory.
Descripción

Liver Dysfunction; serum alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1883008
6. kidneys: impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
Descripción

renal dysfunction; serum-creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
7. any disease judged by the investigator to affect the trial.
Descripción

Compliance behavior Limited Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
8. pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
Descripción

Contraception status; hysterectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0020699
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT01461616

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. informed consent obtained before any trial-related activities.
boolean
C0021430 (UMLS CUI [1])
diabetes mellitus type 1
Item
2. diagnosis of diabetes mellitus according to who criteria; history and clinical course consistent with type 1 diabetes mellitus.
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
continuous subcutaneous insulin infusion
Item
3. diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (csii) at least 6 months at time of inclusion.
boolean
C0393124 (UMLS CUI [1])
Dosage insulin
Item
4. total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
boolean
C0178602 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
hba1c
Item
5. hba1c between 6% and 9% (both values included).
boolean
C0019018 (UMLS CUI [1])
age
Item
6. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
bmi
Item
7. bmi between 18.5 and 28 kg /m2 (including both values).
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity study drugs
Item
1. known or suspected allergy to trial product(s) or related products.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
hypoglycaemic episode
Item
2. recurrent major hypoglycaemic episodes.
boolean
C0745153 (UMLS CUI [1])
unstable angina pectoris; nyha classification
Item
3. heart: unstable angina pectoris, ami < 12 months or heart insufficiency classified according to nyha iii-iv
boolean
C0002965 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
blood pressure; uncontrolled hypertension
Item
4. blood pressure: severe uncontrolled hypertension with bp > 180/110 mmhg, sitting
boolean
C0005823 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
Liver Dysfunction; serum alanine aminotransferase measurement
Item
5. liver: impaired hepatic function corresponding to serum-alat or basic phosphatase > 2 x upper reference limit of the local laboratory.
boolean
C0086565 (UMLS CUI [1])
C1883008 (UMLS CUI [2])
renal dysfunction; serum-creatinine
Item
6. kidneys: impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Compliance behavior Limited Comorbidity
Item
7. any disease judged by the investigator to affect the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraception status; hysterectomy
Item
8. pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
boolean
C0420837 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
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