Comparison of the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial setting and the effectiveness in a routine care setting: Results of a comparative effectiveness study.

Abstract

To compare the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial (RCT) to the effectiveness in an implementation trial (IT). 135 people with diabetes on insulin pump treatment (CSII) underwent structured education with INPUT under RCT-conditions, 191 people with diabetes on CSII underwent structured education with INPUT under IT-conditions. Baseline characteristics and treatment outcomes at the 6-month follow-up were compared. At baseline, RCT-participants were younger (42.7 ± 14.2 vs. 47.2 ± 14.1 years, p = 0.005), had higher HbA1c-values (8.3 ± 0.8% vs. 7.8 ± 1.2%, p = 0.001) and had more diabetes-related distress (27.8 ± 16.4 vs 22.4 ± 14.4, p = 0.002). At follow-up, INPUT results were comparable under the RCT and IT settings. After adjustment for baseline HbA1c, reduction of HbA1c in the IT was significantly greater than in the RCT (Δ0.17%; 95% CI 0.023-0.319%, p = 0.024). Participants with higher HbA1c-levels, more diabetes-related distress and more hypoglycemia problems were most likely to benefit from INPUT regardless of the trial setting. Efficacy of the INPUT program for people with CSII was demonstrated under RCT- and routine care conditions. Education with the INPUT program is effective not only under standardized RCT conditions but also under conditions of routine care.