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. 2016 Apr 13;10(3):754–761. doi: 10.1177/1932296816642578

Table 2.

Detailed Description of Procedures.

Information Informed consent Check criteria Blinded CGM Demographics, medical history DTSQs, WHO-5, SWE-HFS, hypoglycemia confidence, SWE-PAID-20, IPAQ DTSQc HbA1c Creatinine, sensitive CRP, blood lipids, apolipoproteins, biobank samples BMI, waist-hip ratio Blood pressure A/C ratio Insulin dose Download SMBG Download CGM, evaluate use Optimization by
CGM/SMBG only
Concomitant medication AE, SAE Wash-out period
Visit 1 X
Visit 2 x x
Run-in x x x x x
Randomization x x x x x x x x x x x
Week 2 x x x x x
Week 4 x x x x x x
Week 13 x x x x x x
Week 23-26 x
Week 26 x x x x x x x x x x x
Week 27-43 x
Week 40-43 x x x x x
Week 43 x x x x x x x x x x x
Week 45 x x x x x
Week 47 x x x x x x
Week 56 x x x x x x
Week 66-69 x
Week 69 x x x x x x x x x x x x

Physical examination is to be performed at visit 2 (inclusion), visit 9 (week 26), visit 11 (week 43), and visit 16 (week 69). Education on Dexcom G4 system will be performed at start visit, week 2, and week 4 in each period. Knowledge on how to perform SMBG will be checked and education will be performed if judged clinically indicated. At randomization and week 43, basic knowledge of insulin dosing will be checked and, if necessary, patients will be educated about basic insulin dosing. At visit week 13 and week 26 (and corresponding to week 56 and week 69) participants using CGM will be asked how frequently they look at the receiver screen.