ID

32625

Beschreibung

Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00442767

Link

https://clinicaltrials.gov/show/NCT00442767

Stichworte

Versionen (1)
  1. 08.11.18 08.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. November 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00442767

Englisch

Eligibility Type 1 Diabetes Mellitus NCT00442767

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes only
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
diagnosed with t1dm for at least 1 year
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
hba1c less than or equal to 8.5%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
currently treated using insulin glargine with or without humalog/ novolog or on the insulin pump
Beschreibung

Insulin Glargine | Humalog | Humalog Absent | NovoLog | NovoLog Absent | Insulin pump present

Datentyp

boolean

Alias
UMLS CUI [1]
C0907402
UMLS CUI [2]
C0528249
UMLS CUI [3,1]
C0528249
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0939412
UMLS CUI [5,1]
C0939412
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C1385356
hemoglobin equal to or greater than 12mg/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
otherwise healthy, except for t1dm and treated hypothyroidism
Beschreibung

Healthy | Exception Insulin-Dependent Diabetes Mellitus | Exception Hypothyroidism Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011854
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020676
UMLS CUI [3,3]
C1522326
negative pregnancy test, in the case of females
Beschreibung

Gender Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
lack of supportive family
Beschreibung

Family Supportive Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C0332268
evidence or history of chemical abuse
Beschreibung

Chemical abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0740858
bmi (body mass index) greater than the 90th percentile or less than the 10th percentile for age
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
patient who is poorly compliant with current insulin management and/or prescribed self blood glucose monitoring
Beschreibung

Poor compliance Insulin administration management | Poor compliance Blood Glucose Self-Monitoring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C1272418
UMLS CUI [2,1]
C0032646
UMLS CUI [2,2]
C0005803
patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/
Beschreibung

Recurrent hypoglycemic episodes Severe | Requirement Assistance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1846288
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1269765
hospitalizations) in the past 6 months
Beschreibung

Recurrent hypoglycemic episodes Severe | Hospitalization Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1846288
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1708385
have hypoglycemia unawareness
Beschreibung

Hypoglycemia unawareness

Datentyp

boolean

Alias
UMLS CUI [1]
C0342317
have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
Beschreibung

Gastroparesis | Requirement Gastrointestinal motility stimulant combinations

Datentyp

boolean

Alias
UMLS CUI [1]
C0152020
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C2010600
pregnant or lactating patients, or patients planning on becoming pregnant
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Ähnliche Modelle

Eligibility Type 1 Diabetes Mellitus NCT00442767

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes only
boolean
C0011854 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with t1dm for at least 1 year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c less than or equal to 8.5%
boolean
C0474680 (UMLS CUI [1])
Insulin Glargine | Humalog | Humalog Absent | NovoLog | NovoLog Absent | Insulin pump present
Item
currently treated using insulin glargine with or without humalog/ novolog or on the insulin pump
boolean
C0907402 (UMLS CUI [1])
C0528249 (UMLS CUI [2])
C0528249 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0939412 (UMLS CUI [4])
C0939412 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1385356 (UMLS CUI [6])
Hemoglobin measurement
Item
hemoglobin equal to or greater than 12mg/dl
boolean
C0518015 (UMLS CUI [1])
Healthy | Exception Insulin-Dependent Diabetes Mellitus | Exception Hypothyroidism Treated
Item
otherwise healthy, except for t1dm and treated hypothyroidism
boolean
C3898900 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020676 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Gender Pregnancy test negative
Item
negative pregnancy test, in the case of females
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Family Supportive Lacking
Item
lack of supportive family
boolean
C0015576 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Chemical abuse
Item
evidence or history of chemical abuse
boolean
C0740858 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) greater than the 90th percentile or less than the 10th percentile for age
boolean
C1305855 (UMLS CUI [1])
Poor compliance Insulin administration management | Poor compliance Blood Glucose Self-Monitoring
Item
patient who is poorly compliant with current insulin management and/or prescribed self blood glucose monitoring
boolean
C0032646 (UMLS CUI [1,1])
C1272418 (UMLS CUI [1,2])
C0032646 (UMLS CUI [2,1])
C0005803 (UMLS CUI [2,2])
Recurrent hypoglycemic episodes Severe | Requirement Assistance
Item
patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/
boolean
C1846288 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1269765 (UMLS CUI [2,2])
Recurrent hypoglycemic episodes Severe | Hospitalization Required
Item
hospitalizations) in the past 6 months
boolean
C1846288 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1708385 (UMLS CUI [2])
Hypoglycemia unawareness
Item
have hypoglycemia unawareness
boolean
C0342317 (UMLS CUI [1])
Gastroparesis | Requirement Gastrointestinal motility stimulant combinations
Item
have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility
boolean
C0152020 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C2010600 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or lactating patients, or patients planning on becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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