Efficacy of an Education Program for People With Diabetes and Insulin Pump Treatment (INPUT): Results From a Randomized Controlled Trial.

Abstract

Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status. This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16-75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA_1c change from baseline to 6 months. Secondary outcomes were incidence of severe hypoglycemia and changes in behavioral and psychosocial measures. Between 1 April 2016 and 26 April 2016, 268 people with diabetes and a mean duration of CSII therapy of 9.5 years were randomly assigned to the INPUT group (<i>n</i> = 135) or control group (<i>n</i> = 133). At 6 months, HbA_1c improved in the INPUT group (8.33 ± 0.8 vs. 8.04 ± 0.9; <i>P</i> < 0.0001) but not in the control group (8.33 ± 1.0 vs. 8.27 ± 1.0; <i>P</i> = 0.11). The between-group difference in HbA_1c reduction was significant, favoring INPUT (-0.28% vs. -0.06%, Δ -0.22%, 95% CI -0.38 to -0.06; <i>P</i> = 0.0029). The incidence rate ratio of severe hypoglycemia was 3.55 times higher for participants in the control group than for those in the INPUT group (95% CI 1.50-8.43; <i>P</i> = 0.0041). The INPUT education program led to a significant improvement in glycemic control and incidence of severe hypoglycemia in insulin pump users.