ID

29095

Beskrivning

Low Glycemic Index Diet in Patients With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01184703

Länk

https://clinicaltrials.gov/show/NCT01184703

Nyckelord

Versioner (1)
  1. 2018-02-23 2018-02-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT01184703

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT01184703

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type i diabetes, durability >5 years
Beskrivning

Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
age 20-65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
normal weight (bmi 19-26 kg/m2)
Beskrivning

Normal weight | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C2712185
UMLS CUI [2]
C1305855
diabetic treatment with mealtime and bedtime insulin.
Beskrivning

Diabetes Therapy | Mealtime Insulin | Bedtime Insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C3274787
UMLS CUI [2,1]
C0587119
UMLS CUI [2,2]
C0021641
UMLS CUI [3,1]
C0521112
UMLS CUI [3,2]
C0021641
hba1c ≤10 %
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
informed consent to participate in the study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
Beskrivning

Complications of Diabetes Mellitus | Neuropathy | Foot Ulcer | Gastroparesis

Datatyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0085119
UMLS CUI [4]
C0152020
a known food intolerance of gluten, leguminous plants, nuts or almonds.
Beskrivning

Food intolerance Gluten | Food intolerance Legumes | Food intolerance Nuts | Food intolerance Almonds

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149696
UMLS CUI [1,2]
C2362561
UMLS CUI [2,1]
C0149696
UMLS CUI [2,2]
C0023263
UMLS CUI [3,1]
C0149696
UMLS CUI [3,2]
C0028723
UMLS CUI [4,1]
C0149696
UMLS CUI [4,2]
C0440286
pregnancy or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent participation in another research study with metabolic effects.
Beskrivning

Study Subject Participation Status | Metabolic effects

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2945675
previously regular follow-up with a dietician at sdc during the last year.
Beskrivning

Follow-up Regular Dietitian

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C3536818
adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
Beskrivning

Therapeutic procedure Adjustment | Exception Insulin | Exception Nutritional Supplements Associated with Metabolic effects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0456081
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0242295
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C2945675
non acceptance of the study diet or food products that are recommended in the study.
Beskrivning

Clinical Trial Diet Rejected | Clinical Trial Food product Rejected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0012155
UMLS CUI [1,3]
C1548437
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0681562
UMLS CUI [2,3]
C1548437
disability to read and understand the danish language.
Beskrivning

Able to read Danish language | Comprehension Danish language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0010969
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0010969
unable to receive and/or store the test products.
Beskrivning

Investigational New Drugs Receive Unable | Investigational New Drugs Store Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1698986
UMLS CUI [2,3]
C1299582
place of residence >1 hr drive from sdc.
Beskrivning

Residence Remote Medical center

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
UMLS CUI [1,3]
C0565990
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT01184703

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type i diabetes, durability >5 years
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
age 20-65 years
boolean
C0001779 (UMLS CUI [1])
Normal weight | Body mass index
Item
normal weight (bmi 19-26 kg/m2)
boolean
C2712185 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Diabetes Therapy | Mealtime Insulin | Bedtime Insulin
Item
diabetic treatment with mealtime and bedtime insulin.
boolean
C3274787 (UMLS CUI [1])
C0587119 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0521112 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
Glucohemoglobin measurement
Item
hba1c ≤10 %
boolean
C0202054 (UMLS CUI [1])
Informed Consent
Item
informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Complications of Diabetes Mellitus | Neuropathy | Foot Ulcer | Gastroparesis
Item
diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
boolean
C0342257 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0085119 (UMLS CUI [3])
C0152020 (UMLS CUI [4])
Food intolerance Gluten | Food intolerance Legumes | Food intolerance Nuts | Food intolerance Almonds
Item
a known food intolerance of gluten, leguminous plants, nuts or almonds.
boolean
C0149696 (UMLS CUI [1,1])
C2362561 (UMLS CUI [1,2])
C0149696 (UMLS CUI [2,1])
C0023263 (UMLS CUI [2,2])
C0149696 (UMLS CUI [3,1])
C0028723 (UMLS CUI [3,2])
C0149696 (UMLS CUI [4,1])
C0440286 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Metabolic effects
Item
concurrent participation in another research study with metabolic effects.
boolean
C2348568 (UMLS CUI [1])
C2945675 (UMLS CUI [2])
Follow-up Regular Dietitian
Item
previously regular follow-up with a dietician at sdc during the last year.
boolean
C1522577 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3536818 (UMLS CUI [1,3])
Therapeutic procedure Adjustment | Exception Insulin | Exception Nutritional Supplements Associated with Metabolic effects
Item
adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
boolean
C0087111 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C2945675 (UMLS CUI [3,4])
Clinical Trial Diet Rejected | Clinical Trial Food product Rejected
Item
non acceptance of the study diet or food products that are recommended in the study.
boolean
C0008976 (UMLS CUI [1,1])
C0012155 (UMLS CUI [1,2])
C1548437 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0681562 (UMLS CUI [2,2])
C1548437 (UMLS CUI [2,3])
Able to read Danish language | Comprehension Danish language
Item
disability to read and understand the danish language.
boolean
C0586740 (UMLS CUI [1,1])
C0010969 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0010969 (UMLS CUI [2,2])
Investigational New Drugs Receive Unable | Investigational New Drugs Store Unable
Item
unable to receive and/or store the test products.
boolean
C0013230 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C1698986 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Residence Remote Medical center
Item
place of residence >1 hr drive from sdc.
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,3])
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