Patients diagnosed with diabetes need comprehensive care in the first few months of the diagnosis as management can be overwhelming and time-consuming. Patients and family members need to be educated about testing blood sugar, taking medications especially insulin, going to their medical appointments, ...
In addition to planned interim analyses, the trial included a blinded sample size reestimation plan to be conducted prior to the first interim analysis. The plan was in place to avoid an underpowered trial if the assumed control proportion was incorrect. Stopping the trial due to harm would be...
Women who were pregnant or nursing, had hyperglycemic symptoms, were on hypoglycemic agents, or with a previous diagnosis of diabetes melllitus (DM), had advanced DM complications, dementia, a non-compensated endocrinopathy, or severe behavioral problems were excluded. The protocol was previously ...