Use of a subcutaneous injection port to improve glycemic control in children with type 1 diabetes.

OBJECTIVE: To determine if use of an injection port, the Insuflon, would help to improve glycemic control in youth with type 1 diabetes (TID) who were in suboptimal glycemic control (hemoglobin A1c, HbA1c >8.0%). STUDY DESIGN: A three-arm randomized protocol was used to study the effects of the Insuflon (a subcutaneous injection port) vs. an alarmable blood glucose meter vs. a control group on glycemic control in 66 youth with T1D. All participants used insulin glargine as their basal insulin and the NovoPen Junior with insulin aspart as their rapid-acting insulin. Participants were randomized into control, alarm, or Insuflon groups. HbA1c levels were the primary outcome with values at baseline, 3, and 6 months. RESULTS: Initial parameters were similar in the three groups. HbA1c values were significantly lower for youth who used the Insuflon than for the control group at 3 and 6 months (p = 0.025). The HbA1c values (in %) for youth using the Insuflon decreased significantly from 9.4 at screening to 8.7 at 3 months (p < 0.001) and 8.5 at 6 months (p < 0.001). There were no significant reductions (p > or = 0.05) in the HbA1c values within the other two groups. CONCLUSION: The Insuflon injection port helps some youth with T1D to improve glycemic control.