ID

43066

Description

ODM derived from http://clinicaltrials.gov/show/NCT01303302

Link

http://clinicaltrials.gov/show/NCT01303302

Keywords

Versions (3)
  1. 3/19/13 3/19/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01303302 Diabetes Mellitus, Type 2

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Body mass index
Description

Body mass index >=28 and <=45 (kg/m2)

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Type 2 diabetes duration more than 6 month
Description

Type 2 diabetes duration more than 6 month

Data type

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
Type 2 diabetic sublecys treated with oral anti-diabetic agents
Description

Type 2 diabetic sublecys treated with oral anti-diabetic agents

Data type

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
CL415147
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
Stable anti-diabetic medication for at least 3 month prior to enrollment
Description

Stable anti-diabetic medication for at least 3 month prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1
Description

HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
Description

Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
Description

Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0428568
SNOMED CT 2011_0131
271062006
MedDRA 14.1
10051566
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
Description

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

Data type

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
Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
Description

Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C1305866
SNOMED CT 2011_0131
107647005
MedDRA 14.1
10047890
LOINC Version 232
LP18015-5
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0005911
SNOMED CT 2011_0131
248346009
LOINC Version 232
MTHU021183
If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment
Description

If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C0086440
SNOMED CT 2011_0131
57952007
If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
Description

If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1514756
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 product for the duration of the trial
Description

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

Data type

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 willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
Description

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

Data type

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 competant, 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 competant, 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

Data type

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Insulin therapy
Description

Insulin therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0039798
Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
Description

Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
CL430618
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0232572
SNOMED CT 2011_0131
36735000
UMLS CUI 2011AA
C0027415
LOINC Version 232
MTHU003470
UMLS CUI 2011AA
C0242896
SNOMED CT 2011_0131
14601000
UMLS CUI 2011AA
C0037766
SNOMED CT 2011_0131
8696009
Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0376606
Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
Description

Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)

Data type

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
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0184512
SNOMED CT 2011_0131
409051000
UMLS CUI 2011AA
C0011884
SNOMED CT 2011_0131
4855003
MedDRA 14.1
10012689
LOINC Version 232
MTHU020818
ICD-9-CM Version 2011
362.0
UMLS CUI 2011AA
C0011881
SNOMED CT 2011_0131
127013003
MedDRA 14.1
10061835
ICD-9-CM Version 2011
250.4
UMLS CUI 2011AA
C2984010
UMLS CUI 2011AA
C0001925
SNOMED CT 2011_0131
274769005
MedDRA 14.1
10001580
ICD-10-CM Version 2010
R80.9
Prior wound healing problems
Description

Prior wound healing problems

Data type

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 present psychiatric condition that may impair his or her ability to comply with the study procedure
Description

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

Data type

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 medication
Description

Use of anti-psychotic medication

Data type

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 an eating disorder such as bulimia or binge eating
Description

Diagnosed with an eating disorder such as bulimia or binge eating

Data type

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 endocrinopathy (e.g.Cushing disease, Hypothyroidism)
Description

Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)

Data type

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
CL420107
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
UMLS CUI 2011AA
C0010481
SNOMED CT 2011_0131
47270006
MedDRA 14.1
10011652
ICD-10-CM Version 2010
E24.9
ICD-9-CM Version 2011
255.0
UMLS CUI 2011AA
C0020676
SNOMED CT 2011_0131
40930008
MedDRA 14.1
10021114
LOINC Version 232
MTHU020783
ICD-10-CM Version 2010
E03.9
ICD-9-CM Version 2011
244.9
CTCAE 1105E
E10334
Hiatal hernia requiring surgical repair or paraesophageal hernia
Description

Hiatal hernia requiring surgical repair or paraesophageal hernia

Data type

boolean

Alias
UMLS CUI 2011AA
CL432890
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

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
Diagnosed with impaired liver function (liver enzymes 3 times graeted than normal)
Description

Diagnosed with impaired liver function (liver enzymes 3 times graeted than normal)

Data type

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

Data type

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

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
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

Data type

boolean

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

Diagnosed with gastroparesis or GI motility disorder

Data type

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
C0854121
MedDRA 14.1
10061173
Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn)
Description

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

Data type

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
C0030163
SNOMED CT 2011_0131
14106009
LOINC Version 232
MTHU024521
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.

Data type

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
UMLS CUI 2011AA
CL381648
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.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
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
CL411789
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Use of another investigational device agent in the 30 days prior to enrollment
Description

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

Data type

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

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Change in diabetic medication from between visit 1 and visit 3
Description

Change in diabetic medication from between visit 1 and visit 3

Data type

boolean

Alias
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C0580105
SNOMED CT 2011_0131
182838006
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1550557
HL7 V3 2006_05
AND
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
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

Data type

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
CL411789
UMLS CUI 2011AA
CL414898
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 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Body mass index >=28 and <=45 (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)
Type 2 diabetes duration more than 6 month
Item
Type 2 diabetes duration more than 6 month
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)
Type 2 diabetic sublecys treated with oral anti-diabetic agents
Item
Type 2 diabetic sublecys treated with oral anti-diabetic agents
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
CL415147 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
Stable anti-diabetic medication for at least 3 month prior to enrollment
Item
Stable anti-diabetic medication for at least 3 month prior to enrollment
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1
Item
HbA1c >=7.5% and <=9.5% on visit 1. Subjects with T2DM duration .10 years should have <=9.0% at visit 1
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
Item
Stable HbA1c, defined as no significant change (variation <=0.5%)between a historical value recorded in the subject's medical record with in 3 month prior to enrollment and the HbA1c gathered at visit 1
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
Item
Fasting blood glucose >120 and < 240 mg/dl on visit 1. Subjects with T2DM duration > 10 yaers should have .120 ans<=180 mg/dl at visit 1
boolean
C0428568 (UMLS CUI 2011AA)
271062006 (SNOMED CT 2011_0131)
10051566 (MedDRA 14.1)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
Women with child bearing potential (i.e, not post menopausal or surgically sterilized) must agree to use adequate birth control methods
Item
Women with child bearing 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)
Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
Item
Stable weight, defined as no significant weight change (variation <5%)within three months prior to enrollment
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C1305866 (UMLS CUI 2011AA)
107647005 (SNOMED CT 2011_0131)
10047890 (MedDRA 14.1)
LP18015-5 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0005911 (UMLS CUI 2011AA)
248346009 (SNOMED CT 2011_0131)
MTHU021183 (LOINC Version 232)
If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment
Item
If taking these medication, stable anti-hepertensive and lipid-lowering medication for at least one month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1512806 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0086440 (UMLS CUI 2011AA)
57952007 (SNOMED CT 2011_0131)
If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
Item
If subject is under anti-depressant medication the treatment needs to be stable for at least six month prior to enrollment
boolean
C0750557 (UMLS CUI 2011AA)
C1514756 (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 product for the duration of the trial
Item
Willingness to refrain from using prescription, over the counter or herbal weight loss product 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 willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II System
Item
Ability and willingliness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS II 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 competant, 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 competant, 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
Item
Insulin therapy
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
Item
Taking GLP-1 analogue, such as exenatide (Byette) in the last 3 month before enrollment Taking medication known to affect gastric mobility such as narcotics (chronic use) and anticholinergics/antispasmodics
boolean
C1512806 (UMLS CUI 2011AA)
CL430618 (UMLS CUI 2011AA)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0232572 (UMLS CUI 2011AA)
36735000 (SNOMED CT 2011_0131)
C0027415 (UMLS CUI 2011AA)
MTHU003470 (LOINC Version 232)
C0242896 (UMLS CUI 2011AA)
14601000 (SNOMED CT 2011_0131)
C0037766 (UMLS CUI 2011AA)
8696009 (SNOMED CT 2011_0131)
Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
Item
Use of prescription, over the counter or herbal weight loss product or obesity drugs during the past two month
boolean
C0376606 (UMLS CUI 2011AA)
Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
Item
Experiencing severe and progressing diabetic complications (i.e retinopathy not stabilized, nephropathy with macroalbuminuria)
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)
C1518422 (UMLS CUI 2011AA)
C0184512 (UMLS CUI 2011AA)
409051000 (SNOMED CT 2011_0131)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
C0011881 (UMLS CUI 2011AA)
127013003 (SNOMED CT 2011_0131)
10061835 (MedDRA 14.1)
250.4 (ICD-9-CM Version 2011)
C2984010 (UMLS CUI 2011AA)
C0001925 (UMLS CUI 2011AA)
274769005 (SNOMED CT 2011_0131)
10001580 (MedDRA 14.1)
R80.9 (ICD-10-CM Version 2010)
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 present psychiatric condition that may impair his or her ability to comply with the study procedure
Item
Diagnosed with past or present psychiatric condition that may impair his or her ability to comply with the study procedure
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 medication
Item
Use of anti-psychotic medication
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 an eating disorder such as bulimia or binge eating
Item
Diagnosed with an 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 endocrinopathy (e.g.Cushing disease, Hypothyroidism)
Item
Obesity due to endocrinopathy (e.g.Cushing disease, Hypothyroidism)
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)
CL420107 (UMLS CUI 2011AA)
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)
C0010481 (UMLS CUI 2011AA)
47270006 (SNOMED CT 2011_0131)
10011652 (MedDRA 14.1)
E24.9 (ICD-10-CM Version 2010)
255.0 (ICD-9-CM Version 2011)
C0020676 (UMLS CUI 2011AA)
40930008 (SNOMED CT 2011_0131)
10021114 (MedDRA 14.1)
MTHU020783 (LOINC Version 232)
E03.9 (ICD-10-CM Version 2010)
244.9 (ICD-9-CM Version 2011)
E10334 (CTCAE 1105E)
Hiatal hernia requiring surgical repair or paraesophageal hernia
Item
Hiatal hernia requiring surgical repair or paraesophageal hernia
boolean
CL432890 (UMLS CUI 2011AA)
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 (liver enzymes 3 times graeted than normal)
Item
Diagnosed with impaired liver function (liver enzymes 3 times graeted than normal)
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
CL421546 (UMLS CUI 2011AA)
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 GI motility disorder
Item
Diagnosed with gastroparesis or 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)
C0854121 (UMLS CUI 2011AA)
10061173 (MedDRA 14.1)
Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable or worn)
Item
Use of active medical device (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implantable 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)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
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)
CL381648 (UMLS CUI 2011AA)
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
CL421546 (UMLS CUI 2011AA)
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)
CL411789 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Use of another investigational device agent in the 30 days prior to enrollment
Item
Use of another investigational device 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
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2826244 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Change in diabetic medication from between visit 1 and visit 3
Item
Change in diabetic medication from between visit 1 and visit 3
boolean
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0580105 (UMLS CUI 2011AA)
182838006 (SNOMED CT 2011_0131)
CL426201 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1550557 (UMLS CUI 2011AA)
AND (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (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)
CL411789 (UMLS CUI 2011AA)
CL414898 (UMLS CUI 2011AA)
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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