ID

16119

Beskrivning

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02490085

Länk

https://clinicaltrials.gov/show/NCT02490085

Nyckelord

Versioner (1)
  1. 2016-06-30 2016-06-30 -
Uppladdad den

30 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02490085

Engelsk

Eligibility Type 2 Diabetes NCT02490085

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
2. males and females ≥ 60 years of old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. body mass index between 27 and 40 kg/m2 (inclusive)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
4. non fragile defined based on moorhouse et al. scale [23].
Beskrivning

Frailty Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424594
UMLS CUI [1,2]
C0332197
5. using at least 3 insulin injections per day. however, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
Beskrivning

Administration of insulin U/day | Basal insulin Injection Bedtime | Diabetes Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C0521112
UMLS CUI [3]
C3274787
6. hba1c above 8%.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. advanced
Beskrivning

Kidney Disease Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205179
1. nephropathy defined by creatinine clearance <30 ml/min.
Beskrivning

Kidney Diseases | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0373595
2. retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. if the patient have undergone panphoto-coagulation inclusion is acceptable.
Beskrivning

Retinal Diseases | Proliferative retinopathy | Eye bleeding | Laser therapy for retinal lesion | Panretinal photocoagulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2]
C0339467
UMLS CUI [3]
C0423008
UMLS CUI [4]
C0438670
UMLS CUI [5]
C0730064
3. autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
Beskrivning

Autonomic neuropathy | Gastroparesis Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0259749
UMLS CUI [2,1]
C0152020
UMLS CUI [2,2]
C2826293
2. recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Beskrivning

Macrovascular disease | Acute Coronary Syndrome | Cardiac Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C2609253
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0018821
3. a recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
Beskrivning

Limited Walking Ability caused by Following | Injury of unspecified body region | Limb injury | Myopathy | Pharmaceutical Preparations | Disease Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2674459
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0332282
UMLS CUI [2]
C0496020
UMLS CUI [3]
C0743668
UMLS CUI [4]
C0026848
UMLS CUI [5]
C0013227
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0750502
4. a recent (< 2 months) infection needing iv antibiotic or hospitalization
Beskrivning

Communicable Disease needing Intravenous antibiotic therapy | Communicable Disease needing Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C0559680
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0019993
5. severe hypoglycemic episode within two weeks of screening.
Beskrivning

Hypoglycaemic episode Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
6. current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
Beskrivning

Glucocorticoids Pharmaceutical Preparations Use | Drug Administration Routes | Glucocorticoids Inhalation Low dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1524063
UMLS CUI [2]
C0013153
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0445550
UMLS CUI [3,4]
C0205360
7. recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
Beskrivning

Therapeutic procedure Initiation Interferes with glucose metabolism | Therapeutic procedure Dose Modification Interferes with glucose metabolism | Neuroleptics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1704686
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0596620
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1707811
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0596620
UMLS CUI [3]
C0040615
8. known or suspected allergy to the trial products or meal contents.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Meal Contents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1998602
UMLS CUI [2,3]
C0456205
9. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Beskrivning

Illness Serious Interferes with Study Subject Participation Status | Illness Serious Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0439801
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Similar models

Eligibility Type 2 Diabetes NCT02490085

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Age
Item
2. males and females ≥ 60 years of old.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. body mass index between 27 and 40 kg/m2 (inclusive)
boolean
C1305855 (UMLS CUI [1])
Frailty Absent
Item
4. non fragile defined based on moorhouse et al. scale [23].
boolean
C0424594 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Administration of insulin U/day | Basal insulin Injection Bedtime | Diabetes Therapy
Item
5. using at least 3 insulin injections per day. however, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
boolean
C0199782 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0521112 (UMLS CUI [2,3])
C3274787 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
6. hba1c above 8%.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Kidney Disease Advanced
Item
1. advanced
boolean
C0022658 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Kidney Diseases | Creatinine clearance measurement
Item
1. nephropathy defined by creatinine clearance <30 ml/min.
boolean
C0022658 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Retinal Diseases | Proliferative retinopathy | Eye bleeding | Laser therapy for retinal lesion | Panretinal photocoagulation
Item
2. retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. if the patient have undergone panphoto-coagulation inclusion is acceptable.
boolean
C0035309 (UMLS CUI [1])
C0339467 (UMLS CUI [2])
C0423008 (UMLS CUI [3])
C0438670 (UMLS CUI [4])
C0730064 (UMLS CUI [5])
Autonomic neuropathy | Gastroparesis Clinical Significance
Item
3. autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
boolean
C0259749 (UMLS CUI [1])
C0152020 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Macrovascular disease | Acute Coronary Syndrome | Cardiac Surgery
Item
2. recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
boolean
C2609253 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
Limited Walking Ability caused by Following | Injury of unspecified body region | Limb injury | Myopathy | Pharmaceutical Preparations | Disease Significant
Item
3. a recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
boolean
C2674459 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0496020 (UMLS CUI [2])
C0743668 (UMLS CUI [3])
C0026848 (UMLS CUI [4])
C0013227 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
Communicable Disease needing Intravenous antibiotic therapy | Communicable Disease needing Hospitalization
Item
4. a recent (< 2 months) infection needing iv antibiotic or hospitalization
boolean
C0009450 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Hypoglycaemic episode Severe
Item
5. severe hypoglycemic episode within two weeks of screening.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Glucocorticoids Pharmaceutical Preparations Use | Drug Administration Routes | Glucocorticoids Inhalation Low dose Stable
Item
6. current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
boolean
C0017710 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0013153 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Therapeutic procedure Initiation Interferes with glucose metabolism | Therapeutic procedure Dose Modification Interferes with glucose metabolism | Neuroleptics
Item
7. recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
boolean
C0087111 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0596620 (UMLS CUI [2,4])
C0040615 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Meal Contents
Item
8. known or suspected allergy to the trial products or meal contents.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0456205 (UMLS CUI [2,3])
Illness Serious Interferes with Study Subject Participation Status | Illness Serious Compliance behavior Limited
Item
9. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
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