Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial

Randomized controlled trial with main outcome measure being HbA1c at 0, 3 and 6 months. Secondary outcomes were frequency of adverse events (hypoglycemia, diabetic ketoacidosis, weight gain) and scores on the Diabetes Quality of Life Measure for Youth (DQOLY).18 subjects (10 control, 8 intervention). Mean years (standard deviations) for control and intervention respectively were: age at diagnosis of DM1 6.31 (2.91) vs 7.76 (3.22), duration of DM1 5.96 (4.95) vs 3.76 (3.37). No significant differences were seen in the mean HbA1c between control and intervention at 0 months [8.48(0.86) vs 8.57(1.13)], 3 months [8.47(0.50) vs 7.99(0.61)], or 6 months [8.42(0.63) vs 8.30(0.76)]. No significant differences were found between groups for frequency of adverse events or DQOLY.In this pilot study, incorporating LAIA in a BID regimen did not cause deterioration in HbA1c or increases in adverse events; suggesting that this may be a viable option for families where a more simplified insulin regimen would be beneficial and compliance may be improved.ClinicalTrials.gov: NCT00522210Children with type 1 diabetes (DM1) require multiple daily injections of insulin to maintain good glycemic control. The Diabetes Control and Complications Trial (DCCT) has shown that intensive insulin treatment using at least three times daily (TID) injections achieves superior blood glucose control with decreased risk of long term complications than conventional insulin treatment using once daily or twice daily (BID) injections [1,2]. However, this study was done when long acting insulin analogues (LAIA) were not available which limited the types of insulin regimens and there are limited randomized controlled trials assessing analogue insulins in children. Multiple daily injection regimens are not consistently superior in children and other factors including patient support and team cohesion play large roles in glycemic control [3]. Many patients find it difficult to adhere to TID injections since it is