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. 2020 Dec 20;4(2):e00204. doi: 10.1002/edm2.204
Assigned group Age (years) Gender Weight in pounds/BMI Baseline A1c Reason for withdrawal Final outcome after withdrawal
Control 77 M 230/35 9.4% He wanted to switch MDI to the intervention group and refused to remain in control group. Taking the study medications from PCP.
Control 59 F 208/31.6 8.3% PCP discontinued basal prandial insulin. Taking U‐500 insulin.
Intervention 28 F 186.6/32.2 9.1% Lost to follow‐up/did not return to 3rd visit She continues to take the same study medication through PCP.
Intervention 27 F 223.4/43.1 11.4% adverse event (nausea/vomiting/headache) Withdrew from study after 3 weeks. Complete resolution of symptoms after stopping study medications.

PCP, Primary Care Provider.