Eligible children were assigned by simple randomization. Those patients less than 6 years, who showed up in the outpatient diabetology clinic, were collected over a period of 3 months. Prior to the study, the children were on NPH insulin and insulin glargine. At baseline, all participants were randomly assigned to one of the treatment groups and they were put under regular follow-up weekly for 1 month to adjust the basal dose and for education. Accordingly, group A were those who received insulin degludec (Tresiba; Novo Nordisk, Bagsvaerd, Denmark) once per day, group B were on insulin glargine once per day (Lantus®; Sanofi-Aventis, Frankfurt, Germany), and group C on NPH insulin (NPH, human isophane insulin®; Novo Nordisk A/S) twice daily. The 3 groups received insulin Aspart (NovoRapid®, Novo Nordisk, Copenhagen, Denmark) as the mealtime insulin, three times daily.
During the treatment period, parents were asked to measure SMBG 7 times daily, and gluco-strips were made available for them for the whole study period. The basal-bolus insulin doses were adjusted according to ISPAD guidelines [15 (link)] aiming for a fasting/pre-prandial SMBG target of 70–120 mg/dL and a postprandial of 90–198 mg/dL. The patients were followed monthly during the study period. They were exposed to similar educational gains all through.
During the treatment period, parents were asked to measure SMBG 7 times daily, and gluco-strips were made available for them for the whole study period. The basal-bolus insulin doses were adjusted according to ISPAD guidelines [15 (link)] aiming for a fasting/pre-prandial SMBG target of 70–120 mg/dL and a postprandial of 90–198 mg/dL. The patients were followed monthly during the study period. They were exposed to similar educational gains all through.