ID

33103

Description

Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00922649

Lien

https://clinicaltrials.gov/show/NCT00922649

Mots-clés

Versions (1)
  1. 27/11/2018 27/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00922649

Anglais

Eligibility Type 2 Diabetes NCT00922649

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. is 18 to 75 years of age, inclusive;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. has a clinical diagnosis of type 2 diabetes mellitus;
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
3. is anti-glutamic acid decarboxylase (gad) antibody negative;
Description

Anti-GAD antibody negative

Type de données

boolean

Alias
UMLS CUI [1]
C1167898
4. has an a1c ≥ 7.0% and ≤ 10.5%;
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
5. has a body mass index (bmi) ≥ 25 kg/m2 and ≤ 40 kg/m2;
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
6. is treated with either ≥ 2 oral antidiabetic agents (oa) or basal insulin ± oa(s) or basal-bolus insulin ± oa(s) for at least 3 months (subjects may also be treated with exenatide [byetta] or pramlintide [symlin].
Description

Antidiabetics Oral Quantity | Insulin Basal | Bolus Insulin Basal | exenatide | Byetta | Pramlintide | Symlin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0205112
UMLS CUI [3,1]
C1705509
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0205112
UMLS CUI [4]
C0167117
UMLS CUI [5]
C1636686
UMLS CUI [6]
C0537551
UMLS CUI [7]
C1174780
7. if on concomitant metformin, has serum creatinine < 1.5 mg/dl (male) or <1.4 mg/dl (female);
Description

Metformin | Creatinine measurement, serum | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
8. if female, has a negative urine pregnancy test
Description

Gender Urine pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
Description

Recurrent severe hypoglycemia Episodes Quantity | Requirement Assistance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0342316
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1269765
2. has clinical cardiovascular disease (cvd) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ecg at rest, changes on graded exercise test, or positive cardiac imaging test results;
Description

Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization Arterial | Angina Pectoris With Resting ECG Changes Ischemic | Exercise test Changes | Cardiac imaging procedure Positive

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0581603
UMLS CUI [4,2]
C0221464
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0332287
UMLS CUI [5,3]
C3897699
UMLS CUI [5,4]
C0475224
UMLS CUI [6,1]
C0015260
UMLS CUI [6,2]
C0392747
UMLS CUI [7,1]
C1096014
UMLS CUI [7,2]
C1514241
3. has abnormalities on the screening (visit 1) 12-lead ecg that are deemed by the investigator to be clinically significant;
Description

12 lead ECG Abnormality

Type de données

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
4. is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
Description

Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Steroids Intranasal | Topical steroids

Type de données

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C2825233
UMLS CUI [3,2]
C1556154
UMLS CUI [4]
C2065041
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C1522224
UMLS CUI [6,1]
C0038317
UMLS CUI [6,2]
C0001560
UMLS CUI [7]
C2064827
5. currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
Description

Substance Use Disorders | Compliance behavior Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
6. has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
Description

Medical condition Affecting Completion of clinical trial | Laboratory finding Affecting Completion of clinical trial | Medical History Affecting Completion of clinical trial | Medical condition Affecting Personal Well-Being | Laboratory finding Affecting Personal Well-Being | Medical History Affecting Personal Well-Being

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1821407
UMLS CUI [5,1]
C0587081
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1821407
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C1821407
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Similar models

Eligibility Type 2 Diabetes NCT00922649

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. is 18 to 75 years of age, inclusive;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
2. has a clinical diagnosis of type 2 diabetes mellitus;
boolean
C0011860 (UMLS CUI [1])
Anti-GAD antibody negative
Item
3. is anti-glutamic acid decarboxylase (gad) antibody negative;
boolean
C1167898 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. has an a1c ≥ 7.0% and ≤ 10.5%;
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
5. has a body mass index (bmi) ≥ 25 kg/m2 and ≤ 40 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral Quantity | Insulin Basal | Bolus Insulin Basal | exenatide | Byetta | Pramlintide | Symlin
Item
6. is treated with either ≥ 2 oral antidiabetic agents (oa) or basal insulin ± oa(s) or basal-bolus insulin ± oa(s) for at least 3 months (subjects may also be treated with exenatide [byetta] or pramlintide [symlin].
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0205112 (UMLS CUI [2,2])
C1705509 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0205112 (UMLS CUI [3,3])
C0167117 (UMLS CUI [4])
C1636686 (UMLS CUI [5])
C0537551 (UMLS CUI [6])
C1174780 (UMLS CUI [7])
Metformin | Creatinine measurement, serum | Gender
Item
7. if on concomitant metformin, has serum creatinine < 1.5 mg/dl (male) or <1.4 mg/dl (female);
boolean
C0025598 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Gender Urine pregnancy test negative
Item
8. if female, has a negative urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Recurrent severe hypoglycemia Episodes Quantity | Requirement Assistance
Item
1. has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
boolean
C0342316 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C1269765 (UMLS CUI [2,2])
Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Revascularization Arterial | Angina Pectoris With Resting ECG Changes Ischemic | Exercise test Changes | Cardiac imaging procedure Positive
Item
2. has clinical cardiovascular disease (cvd) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ecg at rest, changes on graded exercise test, or positive cardiac imaging test results;
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0581603 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0332287 (UMLS CUI [5,2])
C3897699 (UMLS CUI [5,3])
C0475224 (UMLS CUI [5,4])
C0015260 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C1096014 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
12 lead ECG Abnormality
Item
3. has abnormalities on the screening (visit 1) 12-lead ecg that are deemed by the investigator to be clinically significant;
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Steroids Intranasal | Topical steroids
Item
4. is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
boolean
C2825233 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0038317 (UMLS CUI [6,1])
C0001560 (UMLS CUI [6,2])
C2064827 (UMLS CUI [7])
Substance Use Disorders | Compliance behavior Lacking
Item
5. currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
boolean
C0038586 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Medical condition Affecting Completion of clinical trial | Laboratory finding Affecting Completion of clinical trial | Medical History Affecting Completion of clinical trial | Medical condition Affecting Personal Well-Being | Laboratory finding Affecting Personal Well-Being | Medical History Affecting Personal Well-Being
Item
6. has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1821407 (UMLS CUI [4,3])
C0587081 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1821407 (UMLS CUI [5,3])
C0262926 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C1821407 (UMLS CUI [6,3])
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