ID

43067

Description

ODM derived from http://clinicaltrials.gov/show/NCT01303315

Lien

http://clinicaltrials.gov/show/NCT01303315

Mots-clés

Versions (3)
  1. 19/03/2013 19/03/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT01303315 Diabetes Mellitus, Type 2

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 21 Years to 70 Years
Description

age 21 Years to 70 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Type 2 diabetes duration > 6 months and < 10 years
Description

Type 2 diabetes duration > 6 months and < 10 years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
7.8% < HbA1c < 10.5% if T2DM duration<= 5 years
Description

7.8% < HbA1c < 10.5% if T2DM duration<= 5 years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
7.8% < HbA1c < 10.0% if T2DM duration > 5 years
Description

7.8% < HbA1c < 10.0% if T2DM duration > 5 years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Body mass index
Description

BMI < 40 kg/m2

Type de données

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Taking at least one oral anti-diabetic medication
Description

Taking at least one oral anti-diabetic medication

Type de données

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:
Description

Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:

Type de données

boolean

Alias
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1705253
a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration < 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration > 5 years
Description

a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration < 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration > 5 years

Type de données

boolean

Alias
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C0039798
b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks
Description

b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks

Type de données

boolean

Alias
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205458
SNOMED CT 2011_0131
82809009
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
Description

Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Type de données

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0015787
SNOMED CT 2011_0131
169549004
MedDRA 14.1
10056199
If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
Description

If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0086440
SNOMED CT 2011_0131
57952007
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
Description

If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
Description

If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0003289
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
Description

Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial

Type de données

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C0013231
SNOMED CT 2011_0131
329505003, 80288002
UMLS CUI 2011AA
C0376606
UMLS CUI 2011AA
C1572271
Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
Description

Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System

Type de données

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0010995
UMLS CUI 2011AA
C2700391
UMLS CUI 2011AA
C0525058
Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
Description

Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial

Type de données

boolean

Alias
UMLS CUI 2011AA
C0086035
SNOMED CT 2011_0131
32082000
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Able to provide voluntary informed consent
Description

Able to provide voluntary informed consent

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Insulin therapy within the last 3 months
Description

Insulin therapy within the last 3 months

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0039798
GLP-1 receptor agonist therapy longer than 3 months
Description

GLP-1 receptor agonist therapy longer than 3 months

Type de données

boolean

Alias
UMLS CUI 2011AA
C2917359
UMLS CUI 2011AA
C0039798
Diagnosed with renal dysfunction or history of renal dysfunction
Description

Diagnosed with renal dysfunction or history of renal dysfunction

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0151746
Taking medications known to affect gastric motility
Description

Taking medications known to affect gastric motility

Type de données

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0232572
SNOMED CT 2011_0131
36735000
Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months
Description

Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months

Type de données

boolean

Alias
UMLS CUI 2011AA
C0376606
Experiencing severe and progressing diabetic complications
Description

Experiencing severe and progressing diabetic complications

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
Prior wound healing problems
Description

Prior wound healing problems

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1096106
MedDRA 14.1
10053692
CTCAE 1105E
E12057
Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
Description

Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0278060
SNOMED CT 2011_0131
36456004
LOINC Version 232
MTHU001424
CTCAE 1105E
MTHU117157
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
Use of anti-psychotic medications
Description

Use of anti-psychotic medications

Type de données

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0040615
SNOMED CT 2011_0131
10784006, 372482001
LOINC Version 232
MTHU003337
Diagnosed with eating disorder such as bulimia or binge eating
Description

Diagnosed with eating disorder such as bulimia or binge eating

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0013473
SNOMED CT 2011_0131
72366004
MedDRA 14.1
10014062
ICD-10-CM Version 2010
F50.9
ICD-9-CM Version 2011
307.50
UMLS CUI 2011AA
C0006370
SNOMED CT 2011_0131
78004001
MedDRA 14.1
10006549
ICD-10-CM Version 2010
F50.2
UMLS CUI 2011AA
C0596170
SNOMED CT 2011_0131
439960005
ICD-10-CM Version 2010
F50.2
Obesity due to an endocrinopathy
Description

Obesity due to an endocrinopathy

Type de données

boolean

Alias
UMLS CUI 2011AA
C0028754
SNOMED CT 2011_0131
414916001
MedDRA 14.1
10029883
ICD-10-CM Version 2010
E66.0
ICD-9-CM Version 2011
278.00
CTCAE 1105E
E12361
UMLS CUI 2011AA
C0014130
SNOMED CT 2011_0131
362969004
MedDRA 14.1
10014695
LOINC Version 232
MTHU021570
ICD-10-CM Version 2010
E34.9
ICD-9-CM Version 2011
259.9
Hiatal hernia requiring surgical repair or a paraesophageal hernia
Description

Hiatal hernia requiring surgical repair or a paraesophageal hernia

Type de données

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0374711
SNOMED CT 2011_0131
4365001
UMLS CUI 2011AA
C0267725
SNOMED CT 2011_0131
3662000
MedDRA 14.1
10059188
ICD-10-CM Version 2010
K44
Pregnant or lactating
Description

Pregnant or lactating

Type de données

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
Diagnosed with impaired liver function
Description

Diagnosed with impaired liver function

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
Any prior bariatric surgery
Description

Any prior bariatric surgery

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1456587
MedDRA 14.1
10068900
Any history of pancreatitis
Description

Any history of pancreatitis

Type de données

boolean

Alias
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0030305
SNOMED CT 2011_0131
75694006
MedDRA 14.1
10033645
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577.0
CTCAE 1105E
E10930
Personal history of peptic ulcer disease
Description

Any history of peptic ulcer disease within 5 years of enrollment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0375803
ICD-10-CM Version 2010
Z87.11
ICD-9-CM Version 2011
V12.71
Diagnosed with Gastroparesis or other GI motility disorder
Description

Diagnosed with Gastroparesis or other GI motility disorder

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0152020
SNOMED CT 2011_0131
235675006
MedDRA 14.1
10018043
ICD-9-CM Version 2011
536.3
CTCAE 1105E
E10759
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0854121
MedDRA 14.1
10061173
Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn).
Description

Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn).

Type de données

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0025080
SNOMED CT 2011_0131
63653004
LOINC Version 232
MTHU032523
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0013187
UMLS CUI 2011AA
C0582124
SNOMED CT 2011_0131
25937001
Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
Description

Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
Cardiac history that physician feels should exclude the subject from the study.
Description

Cardiac history that physician feels should exclude the subject from the study.

Type de données

boolean

Alias
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Use of another investigational device or agent in the 30 days prior to enrollment
Description

Use of another investigational device or agent in the 30 days prior to enrollment

Type de données

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0013230
A history of life-threatening disease within 5 years of enrollment
Description

A history of life-threatening disease within 5 years of enrollment

Type de données

boolean

Alias
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Description

Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

Type de données

boolean

Alias
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
age 21 Years to 70 Years
Item
age 21 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Type 2 diabetes duration > 6 months and < 10 years
Item
Type 2 diabetes duration > 6 months and < 10 years
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
7.8% < HbA1c < 10.5% if T2DM duration<= 5 years
Item
7.8% < HbA1c < 10.5% if T2DM duration<= 5 years
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
7.8% < HbA1c < 10.0% if T2DM duration > 5 years
Item
7.8% < HbA1c < 10.0% if T2DM duration > 5 years
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
BMI < 40 kg/m2
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Taking at least one oral anti-diabetic medication
Item
Taking at least one oral anti-diabetic medication
boolean
C1512806 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:
Item
Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:
boolean
C2917359 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1705253 (UMLS CUI 2011AA)
a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration < 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration > 5 years
Item
a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was: i. 7.8% < HbA1c < 10.5% if T2DM duration < 5 years ii. 7.8% < HbA1c < 10.0% if T2DM duration > 5 years
boolean
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2917359 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks
Item
b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks
boolean
C2917359 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
Item
Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
Item
If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0086440 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
Item
If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
Item
If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
Item
Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0376606 (UMLS CUI 2011AA)
C1572271 (UMLS CUI 2011AA)
Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
Item
Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0010995 (UMLS CUI 2011AA)
C2700391 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
Item
Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
boolean
C0086035 (UMLS CUI 2011AA)
32082000 (SNOMED CT 2011_0131)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Able to provide voluntary informed consent
Item
Able to provide voluntary informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Insulin therapy within the last 3 months
Item
Insulin therapy within the last 3 months
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
GLP-1 receptor agonist therapy longer than 3 months
Item
GLP-1 receptor agonist therapy longer than 3 months
boolean
C2917359 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Diagnosed with renal dysfunction or history of renal dysfunction
Item
Diagnosed with renal dysfunction or history of renal dysfunction
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
392521001 (SNOMED CT 2011_0131)
C0151746 (UMLS CUI 2011AA)
Taking medications known to affect gastric motility
Item
Taking medications known to affect gastric motility
boolean
C1512806 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0232572 (UMLS CUI 2011AA)
36735000 (SNOMED CT 2011_0131)
Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months
Item
Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months
boolean
C0376606 (UMLS CUI 2011AA)
Experiencing severe and progressing diabetic complications
Item
Experiencing severe and progressing diabetic complications
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
Prior wound healing problems
Item
Prior wound healing problems
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1096106 (UMLS CUI 2011AA)
10053692 (MedDRA 14.1)
E12057 (CTCAE 1105E)
Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
Item
Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Use of anti-psychotic medications
Item
Use of anti-psychotic medications
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0040615 (UMLS CUI 2011AA)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
Diagnosed with eating disorder such as bulimia or binge eating
Item
Diagnosed with eating disorder such as bulimia or binge eating
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0013473 (UMLS CUI 2011AA)
72366004 (SNOMED CT 2011_0131)
10014062 (MedDRA 14.1)
F50.9 (ICD-10-CM Version 2010)
307.50 (ICD-9-CM Version 2011)
C0006370 (UMLS CUI 2011AA)
78004001 (SNOMED CT 2011_0131)
10006549 (MedDRA 14.1)
F50.2 (ICD-10-CM Version 2010)
C0596170 (UMLS CUI 2011AA)
439960005 (SNOMED CT 2011_0131)
F50.2 (ICD-10-CM Version 2010)
Obesity due to an endocrinopathy
Item
Obesity due to an endocrinopathy
boolean
C0028754 (UMLS CUI 2011AA)
414916001 (SNOMED CT 2011_0131)
10029883 (MedDRA 14.1)
E66.0 (ICD-10-CM Version 2010)
278.00 (ICD-9-CM Version 2011)
E12361 (CTCAE 1105E)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
Hiatal hernia requiring surgical repair or a paraesophageal hernia
Item
Hiatal hernia requiring surgical repair or a paraesophageal hernia
boolean
C1514873 (UMLS CUI 2011AA)
C0374711 (UMLS CUI 2011AA)
4365001 (SNOMED CT 2011_0131)
C0267725 (UMLS CUI 2011AA)
3662000 (SNOMED CT 2011_0131)
10059188 (MedDRA 14.1)
K44 (ICD-10-CM Version 2010)
Pregnant or lactating
Item
Pregnant or lactating
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
Diagnosed with impaired liver function
Item
Diagnosed with impaired liver function
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
Any prior bariatric surgery
Item
Any prior bariatric surgery
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1456587 (UMLS CUI 2011AA)
10068900 (MedDRA 14.1)
Any history of pancreatitis
Item
Any history of pancreatitis
boolean
392521001 (SNOMED CT 2011_0131)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Any history of peptic ulcer disease within 5 years of enrollment
Item
Personal history of peptic ulcer disease
boolean
C0375803 (UMLS CUI 2011AA)
Z87.11 (ICD-10-CM Version 2010)
V12.71 (ICD-9-CM Version 2011)
Diagnosed with Gastroparesis or other GI motility disorder
Item
Diagnosed with Gastroparesis or other GI motility disorder
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0152020 (UMLS CUI 2011AA)
235675006 (SNOMED CT 2011_0131)
10018043 (MedDRA 14.1)
536.3 (ICD-9-CM Version 2011)
E10759 (CTCAE 1105E)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0854121 (UMLS CUI 2011AA)
10061173 (MedDRA 14.1)
Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn).
Item
Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn).
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0025080 (UMLS CUI 2011AA)
63653004 (SNOMED CT 2011_0131)
MTHU032523 (LOINC Version 232)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0013187 (UMLS CUI 2011AA)
C0582124 (UMLS CUI 2011AA)
25937001 (SNOMED CT 2011_0131)
Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
Item
Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
boolean
C1516879 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
Cardiac history that physician feels should exclude the subject from the study.
Item
Cardiac history that physician feels should exclude the subject from the study.
boolean
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Use of another investigational device or agent in the 30 days prior to enrollment
Item
Use of another investigational device or agent in the 30 days prior to enrollment
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
A history of life-threatening disease within 5 years of enrollment
Item
A history of life-threatening disease within 5 years of enrollment
boolean
392521001 (SNOMED CT 2011_0131)
C2826244 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
Item
Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
boolean
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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