title: 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.
abstract: BACKGROUND
  Children with type 1 diabetes (DM1) often use three daily (TID) injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA) at dinner in a twice daily (BID) injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at dinner (intervention) to those using a standard TID regimen (control) over 6 months.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00522210.
authors: Department of Pediatrics, University of Calgary, Calgary, T3B 6A8, Canada. Josephine.ho@albertahealthservices.ca.
authors: Josephine
authors: J
authors: Ho
authors: Carol
authors: C
authors: Huang
authors: Alberto
authors: A
authors: Nettel-Aguirre
authors: Danièle
authors: D
authors: Pacaud