Age at type 2 diabetes diagnosis
Item
1. men or women diagnosed with diabetes at age ≥ 30 years (≥ 20 for american indians)
boolean
C1828181 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Type 2 diabetes duration
Item
2. duration of diagnosed diabetes < 10 years
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
HbA1c before randomization
Item
3. hba1c criteria (at final run-in visit, ~2 weeks prior to randomization): 6.8-8.5%
boolean
C0474680 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Daily dose of metformin before randomization duration
Item
4. taking a daily dose of ≥ 1000 mg metformin for a minimum of 8 weeks at final run-in
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
C0449238 (UMLS CUI [1,5])
Willing to administer subcutaneous injections daily | willing pharmaceutical preparations DM additional post randomization | willing to initiate or increase insulin if indicated | willing to perform self-monitoring of blood glucose
Item
5. willingness to administer daily subcutaneous injections, take a second diabetes drug after randomization, potentially initiate insulin and intensify insulin therapy if study metabolic goals are not met, perform self-monitoring of blood glucose
boolean
C0600109 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0021499 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0600109 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
C1524062 (UMLS CUI [2,4])
C0687676 (UMLS CUI [2,5])
C0034656 (UMLS CUI [2,6])
C0600109 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1704686 (UMLS CUI [3,3])
C3146298 (UMLS CUI [3,4])
C0600109 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C3146298 (UMLS CUI [4,4])
C0600109 (UMLS CUI [5,1])
C0005803 (UMLS CUI [5,2])
Fluent in English | fluent in Spanish
Item
6. fluent in either english or spanish
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Negative pregnancy test
Item
7. a negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile)
boolean
C0427780 (UMLS CUI [1])
Informed consent
Item
8. provision of signed and dated informed consent prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
T1D suspected diagnosis | polyuria polydipsia decreased weight lacking treatment response to metformin | monogenic diabetes | diabetes secondary to pancreatic surgery | diabetes secondary to pancreatitis
Item
1. suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) or "secondary" diabetes due to specific causes (e.g. previously diagnosed monogenic syndromes, pancreatic surgery, pancreatitis)
boolean
C0011854 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2,1])
C0085602 (UMLS CUI [2,2])
C1262477 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
C0521982 (UMLS CUI [2,5])
C0025598 (UMLS CUI [2,6])
C3888631 (UMLS CUI [3])
C0011847 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0030274 (UMLS CUI [4,4])
C0011847 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
Current or recent hypoglycemic treatment | exception metformin
Item
2. current or previous (within past 6 months) treatment with any diabetes drug/glucose-lowering medication other than metformin
boolean
C0020616 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Metformin duration
Item
3. more than 10 years of treatment with metformin at time of randomization screening
boolean
C0025598 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Intolerance to study medication | hypersensitivity to study medication | other contraindications to study medication
Item
4. history of intolerance or allergy or other contraindications to any of the proposed study medications
boolean
C1744706 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3854006 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C3854006 (UMLS CUI [3,3])
Participant cohabitates with another study participant
Item
5. resides in the same household with another grade study participant
boolean
C2348568 (UMLS CUI [1,1])
C0221179 (UMLS CUI [1,2])
C1997894 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Glucose-lowering agents disease other | polycystic ovary syndrome
Item
6. current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome
boolean
C0020616 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0032460 (UMLS CUI [2])
Symptomatic hyperglycemia requiring immediate therapy, in the judgment of the physician
Item
7. symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician
boolean
C0022423 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0020456 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C0087111 (UMLS CUI [1,6])
C0205253 (UMLS CUI [1,7])
Recent life-threatening event | planned major surgery
Item
8. a life-threatening event within 30 days prior to screening or currently planned major surgery
boolean
C1517874 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Recent major cardiovascular event | history of myocardial infarction | stroke | vascular procedure | coronary artery or peripheral bypass grafting | peripheral stent placements | coronary stent placements | angioplasty
Item
9. any major cardiovascular event in previous year, including history of myocardial infarction, stroke, or vascular procedure such as coronary artery or peripheral bypass grafting, stent placements (peripheral or coronary) or angioplasty.
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0042381 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C3495795 (UMLS CUI [6])
C0522776 (UMLS CUI [7])
C0948884 (UMLS CUI [8])
C0162577 (UMLS CUI [9])
Pregnancy intention during clinical trial period
Item
10. plans for pregnancy during the course of the study for women of child-bearing potential
boolean
C0032961 (UMLS CUI [1,1])
C0162425 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
(Planned) bariatric surgery | banding procedures | surgical gastric bypass | surgical intestinal bypass
Item
11. history of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass (if banding removed, may be considered eligible after 1 year)
boolean
C1456587 (UMLS CUI [1])
C1456587 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0524722 (UMLS CUI [3,1])
C1719687 (UMLS CUI [3,2])
C0524722 (UMLS CUI [4,1])
C0017125 (UMLS CUI [4,2])
C0524722 (UMLS CUI [5,1])
C0022375 (UMLS CUI [5,2])
History of congestive heart failure | NYHA class
Item
12. history of congestive heart failure (nyha 3 or greater)
boolean
C0018802 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
History of pancreatitis
Item
13. history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Malign neoplasms requiring prior therapy | except skin carcinoma nonmelanomatous
Item
14. history of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1518408 (UMLS CUI [2,3])
Personal or family history of multiple endocrine neoplasia | family history of medullary thyroid cancer
Item
15. personal or family history of men-2 or family history of medullary thyroid cancer
boolean
C0027662 (UMLS CUI [1])
C0027662 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0238462 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Serum creatinine | end stage renal disease requiring renal replacement therapy
Item
16. serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men or end stage renal disease requiring renal replacement therapy
boolean
C0201976 (UMLS CUI [1])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0206074 (UMLS CUI [2,3])
Severe liver disease | acute hepatitis | elevated ALT
Item
17. history of severe liver disease or acute hepatitis or alt > 3 times upper limit of normal
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alcoholism | excessive alcohol consumption
Item
18. current alcoholism or excessive alcohol intake
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
Previous organ transplant
Item
19. previous organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Treatment with oral or systemic glucocorticoids other than short-term treatment | disease likely to require glucocorticoid therapy | inhaled steroids allowed
Item
20. treatment with oral or systemic glucocorticoids (other than short-term treatment, for example for poison ivy) or disease likely to require periodic or regular glucocorticoid therapy (inhaled steroids are allowed)
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0443303 (UMLS CUI [2,4])
C3540777 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3540777 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0750492 (UMLS CUI [5,3])
C0744425 (UMLS CUI [5,4])
C2065041 (UMLS CUI [6])
Atypical antipsychotics
Item
21. treatment with atypical antipsychotics
boolean
C1276996 (UMLS CUI [1])
Hemolytic anemia | chronic transfusion requirement | other condition hba1c results unreliable | hematocrit level
Item
22. history of hemolytic anemia, chronic transfusion requirement, or other condition rendering hba1c results unreliable as indicator of chronic glucose levels, or hematocrit <35 for males and <33 for females
boolean
C0002878 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1879316 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0474680 (UMLS CUI [3,3])
C0749770 (UMLS CUI [3,4])
C0518014 (UMLS CUI [4])
Unstable clinical status | unstable medical status | life expectancy
Item
23. clinically or medically unstable with expected survival <1 year
boolean
C0443343 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0443343 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Unwilling to permit contact with PCP
Item
24. unwillingness to permit sites to contact the pcp to communicate information about the study and the participant's data
boolean
C0558080 (UMLS CUI [1,1])
C0521104 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0033131 (UMLS CUI [1,4])
No primary care physician | inability to identify primary care physician
Item
25. no non-study pcp or inability to identify such a pcp (who will provide non-study care) by the time of final run-in
boolean
C0033131 (UMLS CUI [1,1])
C1706613 (UMLS CUI [1,2])
C0033131 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Participation in another interventional clinical trial
Item
26. participation in another interventional clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C3274035 (UMLS CUI [1,2])
Previous randomization
Item
27. previous randomization in the grade study
boolean
C0034656 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Factors limiting protocol compliance judgement principle investigator | language barrier
Item
28. in the opinion of the principal investigator (pi), any other factor, including language barrier, likely to limit compliance with the protocol
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C1521895 (UMLS CUI [1,5])
C0237167 (UMLS CUI [2])