English

Eligibility Diabetes Type 2 NCT01382264

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
providers
Description

Providers

Data type

boolean

Alias
UMLS CUI [1]
C1138603
1. non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
Description

General Practitioners | Internist General | Physicians, Family | Nurse practitioner | Physician Assistant

Data type

boolean

Alias
UMLS CUI [1]
C0017319
UMLS CUI [2,1]
C0278602
UMLS CUI [2,2]
C0205246
UMLS CUI [3]
C1704221
UMLS CUI [4]
C0028657
UMLS CUI [5]
C0031833
2. absence of orders for deployment or permanent change of station
Description

Absence Order Deployment | Absence Station Change Permanent

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1705178
UMLS CUI [1,3]
C2825812
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1883167
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0205355
3. willingness to recruit up to 19 patients prior to randomization
Description

Recruitment Patients Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2949735
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1265611
4. willingness to deliver "usual care" as defined below in section 6.3.2.
Description

Provide Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C1999230
UMLS CUI [1,2]
C2936643
patients
Description

Patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
patients with a diagnosis of type 2 dm of at least three months duration;
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
history of inadequate glycemic control (a1c < 7.0% but ≤ 11%) determined by at least two a1c values within the previous 6 months
Description

Glycaemia control Inadequate | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3267174
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0474680
willingness to test blood glucose four or more times each day at least once a week, and 8 times each day for one day per month;
Description

Blood glucose measurement times/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
willingness to upload their glucometer to transmit data to a central database every 2 weeks
Description

Glucometer Upload | Data transmission Database

Data type

boolean

Alias
UMLS CUI [1,1]
C0472226
UMLS CUI [1,2]
C1710578
UMLS CUI [2,1]
C0332289
UMLS CUI [2,2]
C0242356
access to a land line telephone in order to upload their glucometer data every 2 weeks
Description

Access to telephone | Glucometer Data Upload

Data type

boolean

Alias
UMLS CUI [1]
C1822200
UMLS CUI [2,1]
C0472226
UMLS CUI [2,2]
C1511726
UMLS CUI [2,3]
C1710578
not using "prandial" regular or a short-acting insulin (e.g. insulin aspart, lispro, glulisine)
Description

Mealtime Insulin Absent | Short-Acting Insulin Absent | Insulin Aspart Absent | Insulin Lispro Absent | Insulin Glulisine Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0587119
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0356365
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1708521
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0293359
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1313386
UMLS CUI [5,2]
C0332197
not using "premixed insulin" (novolin mix, novolog mix, humulin mix, humalog mix)
Description

Premixed insulin Absent | Novolin Mix Absent | NovoLog Mix Absent | Humulin Mix Absent | Humalog Mix Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2069057
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0028467
UMLS CUI [2,2]
C1720722
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3538421
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3538423
UMLS CUI [4,2]
C1720722
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0876055
UMLS CUI [5,2]
C0332197
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
Description

Current Medical Status Stable | Myocardial Infarction Absent | Cerebrovascular accident Absent | Major surgery Absent | Mental disorders Major Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3899485
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0038454
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205164
UMLS CUI [5,3]
C0332197
not taking or not expected to be taking any oral glucocorticoids except for replacement therapy for those with adrenal insufficiency, amphetamines, anabolic, or weight-reducing agents during the course of the study
Description

Glucocorticoids Oral Absent | Exception Replacement therapy Adrenal gland hypofunction | Amphetamines Absent | Anabolic Agents Absent | Weight-Loss Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279033
UMLS CUI [2,3]
C0001623
UMLS CUI [3,1]
C0002667
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1258800
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0376606
UMLS CUI [5,2]
C0332197
not receiving chemotherapy or immunosuppressive therapy access to telephone capable of transmitting data for downloading of a glucose meter
Description

Chemotherapy Absent | Therapeutic immunosuppression Absent | Access to telephone | Data transmission Blood glucose meter

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1822200
UMLS CUI [4,1]
C0332289
UMLS CUI [4,2]
C0472226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
providers
Description

Providers

Data type

boolean

Alias
UMLS CUI [1]
C1138603
1. specialist physicians
Description

Specialist Physician

Data type

boolean

Alias
UMLS CUI [1]
C2348234
2. orders for deployment or permanent change of station
Description

Order Deployment | Station Change Permanent

Data type

boolean

Alias
UMLS CUI [1,1]
C1705178
UMLS CUI [1,2]
C2825812
UMLS CUI [2,1]
C1883167
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0205355
3. unwillingness to recruit up to 19 patients prior to randomization
Description

Recruitment Patients Quantity Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2949735
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0558080
4. no prior experience with management of type 2 diabetes in adults
Description

Experience Absent | Management Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0011860
5. unwillingness to deliver "usual care" as defined below
Description

Provide Standard of Care Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1999230
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0558080
patients
Description

Patients

Data type

boolean

Alias
UMLS CUI [1]
C0030705
1. patients with type 1 diabetes or those with type 2 on prandial rapid-acting insulin or premixed insulins
Description

Diabetes Mellitus, Insulin-Dependent | Short-Acting Insulin Mealtime Non-Insulin-Dependent Diabetes Mellitus | Premixed insulin Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0356365
UMLS CUI [2,2]
C0587119
UMLS CUI [2,3]
C0011860
UMLS CUI [3,1]
C2069057
UMLS CUI [3,2]
C0011860
2. unwillingness to test blood glucose four or more times a day at least once a week and 8 times a day once a month;
Description

Blood glucose measurement times/day Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
UMLS CUI [1,3]
C0558080
3. unwillingness or inability to receive training in using the technology and/or upload blood glucose data every 2 weeks.
Description

Training Blood Glucose Data transmission Unwilling | Training Blood Glucose Data transmission Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0220931
UMLS CUI [1,2]
C0005802
UMLS CUI [1,3]
C0332289
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C0220931
UMLS CUI [2,2]
C0005802
UMLS CUI [2,3]
C0332289
UMLS CUI [2,4]
C1299582
4. no access to a land line telephone in order to upload their glucometer data every 2 week
Description

Access to telephone Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0332268
5. inability to communicate in written and spoken english
Description

Lacking Able to communicate Written English | Lacking Able to communicate Spoken English

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0376245
UMLS CUI [1,4]
C0681288
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0376245
UMLS CUI [2,4]
C0424919
6. organ (kidney, pancreas, liver) transplant recipients
Description

Transplant Recipients | Kidney transplant recipient | Pancreas transplant recipient | Liver transplant recipient

Data type

boolean

Alias
UMLS CUI [1]
C0376387
UMLS CUI [2]
C4304779
UMLS CUI [3]
C2033004
UMLS CUI [4]
C3811922
7. severe impairment of dexterity, vision, or intellectual function
Description

Reduced dexterity Severe | Visual Impairment Severe | Impaired cognition Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1963825
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3665347
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0205082
8. pregnancy verified by a urine pregnancy test at baseline in pre-menopausal women. the pregnancy test will be administered by the project officer at each study site.
Description

Pregnancy | Premenopausal state Urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0430056
9. individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
Description

Patients Availability Unlikely Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0750558
UMLS CUI [1,4]
C3274571
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Eligibility Diabetes Type 2 NCT01382264

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Providers
Item
providers
boolean
C1138603 (UMLS CUI [1])
General Practitioners | Internist General | Physicians, Family | Nurse practitioner | Physician Assistant
Item
1. non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
boolean
C0017319 (UMLS CUI [1])
C0278602 (UMLS CUI [2,1])
C0205246 (UMLS CUI [2,2])
C1704221 (UMLS CUI [3])
C0028657 (UMLS CUI [4])
C0031833 (UMLS CUI [5])
Absence Order Deployment | Absence Station Change Permanent
Item
2. absence of orders for deployment or permanent change of station
boolean
C0332197 (UMLS CUI [1,1])
C1705178 (UMLS CUI [1,2])
C2825812 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1883167 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0205355 (UMLS CUI [2,4])
Recruitment Patients Quantity
Item
3. willingness to recruit up to 19 patients prior to randomization
boolean
C2949735 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Provide Standard of Care
Item
4. willingness to deliver "usual care" as defined below in section 6.3.2.
boolean
C1999230 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
Patients
Item
patients
boolean
C0030705 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
patients with a diagnosis of type 2 dm of at least three months duration;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycaemia control Inadequate | Hemoglobin A1c measurement
Item
history of inadequate glycemic control (a1c < 7.0% but ≤ 11%) determined by at least two a1c values within the previous 6 months
boolean
C3267174 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Blood glucose measurement times/day
Item
willingness to test blood glucose four or more times each day at least once a week, and 8 times each day for one day per month;
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Glucometer Upload | Data transmission Database
Item
willingness to upload their glucometer to transmit data to a central database every 2 weeks
boolean
C0472226 (UMLS CUI [1,1])
C1710578 (UMLS CUI [1,2])
C0332289 (UMLS CUI [2,1])
C0242356 (UMLS CUI [2,2])
Access to telephone | Glucometer Data Upload
Item
access to a land line telephone in order to upload their glucometer data every 2 weeks
boolean
C1822200 (UMLS CUI [1])
C0472226 (UMLS CUI [2,1])
C1511726 (UMLS CUI [2,2])
C1710578 (UMLS CUI [2,3])
Mealtime Insulin Absent | Short-Acting Insulin Absent | Insulin Aspart Absent | Insulin Lispro Absent | Insulin Glulisine Absent
Item
not using "prandial" regular or a short-acting insulin (e.g. insulin aspart, lispro, glulisine)
boolean
C0587119 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0356365 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1708521 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0293359 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1313386 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Premixed insulin Absent | Novolin Mix Absent | NovoLog Mix Absent | Humulin Mix Absent | Humalog Mix Absent
Item
not using "premixed insulin" (novolin mix, novolog mix, humulin mix, humalog mix)
boolean
C2069057 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0028467 (UMLS CUI [2,1])
C1720722 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3538421 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3538423 (UMLS CUI [4,1])
C1720722 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0876055 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Current Medical Status Stable | Myocardial Infarction Absent | Cerebrovascular accident Absent | Major surgery Absent | Mental disorders Major Absent
Item
stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
boolean
C3899485 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0679637 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Glucocorticoids Oral Absent | Exception Replacement therapy Adrenal gland hypofunction | Amphetamines Absent | Anabolic Agents Absent | Weight-Loss Agents Absent
Item
not taking or not expected to be taking any oral glucocorticoids except for replacement therapy for those with adrenal insufficiency, amphetamines, anabolic, or weight-reducing agents during the course of the study
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0279033 (UMLS CUI [2,2])
C0001623 (UMLS CUI [2,3])
C0002667 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1258800 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0376606 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Chemotherapy Absent | Therapeutic immunosuppression Absent | Access to telephone | Data transmission Blood glucose meter
Item
not receiving chemotherapy or immunosuppressive therapy access to telephone capable of transmitting data for downloading of a glucose meter
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1822200 (UMLS CUI [3])
C0332289 (UMLS CUI [4,1])
C0472226 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Providers
Item
providers
boolean
C1138603 (UMLS CUI [1])
Specialist Physician
Item
1. specialist physicians
boolean
C2348234 (UMLS CUI [1])
Order Deployment | Station Change Permanent
Item
2. orders for deployment or permanent change of station
boolean
C1705178 (UMLS CUI [1,1])
C2825812 (UMLS CUI [1,2])
C1883167 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0205355 (UMLS CUI [2,3])
Recruitment Patients Quantity Unwilling
Item
3. unwillingness to recruit up to 19 patients prior to randomization
boolean
C2949735 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
Experience Absent | Management Non-Insulin-Dependent Diabetes Mellitus
Item
4. no prior experience with management of type 2 diabetes in adults
boolean
C0596545 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0376636 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Provide Standard of Care Unwilling
Item
5. unwillingness to deliver "usual care" as defined below
boolean
C1999230 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Patients
Item
patients
boolean
C0030705 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Short-Acting Insulin Mealtime Non-Insulin-Dependent Diabetes Mellitus | Premixed insulin Non-Insulin-Dependent Diabetes Mellitus
Item
1. patients with type 1 diabetes or those with type 2 on prandial rapid-acting insulin or premixed insulins
boolean
C0011854 (UMLS CUI [1])
C0356365 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C2069057 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
Blood glucose measurement times/day Unwilling
Item
2. unwillingness to test blood glucose four or more times a day at least once a week and 8 times a day once a month;
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Training Blood Glucose Data transmission Unwilling | Training Blood Glucose Data transmission Unable
Item
3. unwillingness or inability to receive training in using the technology and/or upload blood glucose data every 2 weeks.
boolean
C0220931 (UMLS CUI [1,1])
C0005802 (UMLS CUI [1,2])
C0332289 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C0220931 (UMLS CUI [2,1])
C0005802 (UMLS CUI [2,2])
C0332289 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Access to telephone Lacking
Item
4. no access to a land line telephone in order to upload their glucometer data every 2 week
boolean
C1822200 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Lacking Able to communicate Written English | Lacking Able to communicate Spoken English
Item
5. inability to communicate in written and spoken english
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0681288 (UMLS CUI [1,4])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0424919 (UMLS CUI [2,4])
Transplant Recipients | Kidney transplant recipient | Pancreas transplant recipient | Liver transplant recipient
Item
6. organ (kidney, pancreas, liver) transplant recipients
boolean
C0376387 (UMLS CUI [1])
C4304779 (UMLS CUI [2])
C2033004 (UMLS CUI [3])
C3811922 (UMLS CUI [4])
Reduced dexterity Severe | Visual Impairment Severe | Impaired cognition Severe
Item
7. severe impairment of dexterity, vision, or intellectual function
boolean
C1963825 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0338656 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Pregnancy | Premenopausal state Urine pregnancy test
Item
8. pregnancy verified by a urine pregnancy test at baseline in pre-menopausal women. the pregnancy test will be administered by the project officer at each study site.
boolean
C0032961 (UMLS CUI [1])
C0232969 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
Patients Availability Unlikely Follow-up
Item
9. individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
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