Eligibility Type 2 Diabetes Mellitus NCT02320253

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StudyEvent: Eligibility
1. Eligibility Type 2 Diabetes Mellitus NCT02320253

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Diabetes Mellitus, Non-Insulin-Dependent

Item

diagnosis of type 2 diabetes

boolean

C0011860 (UMLS CUI [1])

Age

Item

age 18 years or older

boolean

C0001779 (UMLS CUI [1])

Overweight | Obesity | Body mass index

Item

overweight or obese (bmi >25 kg/m2)

boolean

C0497406 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
C1305855 (UMLS CUI [3])

Hemoglobin A1c measurement

Item

hba1c level 7<11%

boolean

C0474680 (UMLS CUI [1])

Systolic Pressure | Diastolic blood pressure

Item

systolic blood pressure (sbp) <160 mmhg, diastolic blood pressure (dbp) <100 mmhg

boolean

C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])

Triglycerides measurement

Item

triglyceride levels <600 mg/dl

boolean

C0202236 (UMLS CUI [1])

Metformin | Metformin allergy | Intolerance to Metformin

Item

taking metformin or have a metformin allergy or intolerance

boolean

C0025598 (UMLS CUI [1])
C0571648 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])

Weight lose Percentage Willing

Item

willing to lose 5-7% of body weight

boolean

C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])

Increase in physical activity mins/week Willing

Item

willing to increase activity to at least 175 minutes/week

boolean

C3694428 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])

Random assignment | Lifestyle change therapy | Nutrition Therapy

Item

willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to nutrition services for medical nutrition therapy

boolean

C0814868 (UMLS CUI [1])
C2960841 (UMLS CUI [2])
C2937349 (UMLS CUI [3])

Health Stable | Absence Comorbidity Severe | Comorbidity Interferes with Interventional procedure | Absence Mental disorder Severe | Absence Heart Disease Significant

Item

stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease

boolean

C0018684 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0018799 (UMLS CUI [5,2])
C0750502 (UMLS CUI [5,3])

Comprehension English Language | Able to communicate English Language | Comprehension Spanish Language | Able to communicate Spanish Language

Item

ability to understand and communicate effectively in english or spanish

boolean

C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0037750 (UMLS CUI [3,2])
C2364293 (UMLS CUI [4,1])
C0037750 (UMLS CUI [4,2])

Blood Glucose Self-Monitoring

Item

willing to self-monitor blood glucose

boolean

C0005803 (UMLS CUI [1])

Subject Diary Completion | Food Diary | Exercise Diary | Blood Glucose Diary

Item

willing to keep a food, exercise, and blood glucose diary

boolean

C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0016452 (UMLS CUI [2,1])
C3890583 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C3890583 (UMLS CUI [3,2])
C0005802 (UMLS CUI [4,1])
C3890583 (UMLS CUI [4,2])

Primary Care Physician | Pharmaceutical Preparations Adjustment | Clinic Visits Health center

Item

have a primary care physician at mgh chelsea, charlestown, or revere health centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider

boolean

C0033131 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0456081 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0475309 (UMLS CUI [3,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Body Weight

Item

weight greater than 350 pounds

boolean

C0005910 (UMLS CUI [1])

Pregnancy | Pregnancy, Planned

Item

pregnant or planning pregnancy in the next year

boolean

C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])

Follow-up Regular Dietitian | Participation Weight Reduction Program

Item

currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program

boolean

C1522577 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3536818 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C3179079 (UMLS CUI [2,2])

Weight Change Amount Timespan

Item

weight change of more than 5 pounds in the previous 3 months.

boolean

C0005911 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])

Study Subject Participation Status | Clinical Trial Diabetes Mellitus

Item

currently enrolled in another diabetes study

boolean

C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])

Lacking Availability of Telephone

Item

lack of availability of telephone

boolean

C0332268 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])

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Eligibility Type 2 Diabetes Mellitus NCT02320253