The Durability of an Intensive, Structured Education-Based Rehabilitation Protocol for Best Insulin Injection Practice: The ISTERP-2 Study
Sandro Gentile, Giuseppina Guarino, Teresa Della Corte, Giampiero Marino, Ersilia Satta, Maria Pasquarella, Carmine Romano, Carmelo Alfrone, Laura Giordano, Fabrizio Loiacono, Maurizio Capace, Rossella Lamberti, Felice Strollo, AMD-OSDI Study Group on Injection Technique, Stefano De-Riu, Nicoletta De-Rosa, G. Grassi, Gabriella Garrapa, Laura Tonutti, Katija Speese, Lia Cucco, MariaTeresa Branca, Amodio Botta, Sandro Gentile, Giuseppina Guarino, Felice Strollo, Gerardo Corigliano, Marco Corigliano, Carmine Martino, Antonio Fasolino, Antonio Vetrano, Agostino Vecchiato, Domenica Oliva, Clelia Lamberti, Domenico Cozzolino, Clementina Brancario, Luca Franco, Teresa Della-Corte, Carmelo Alfarone, Maria Luisa Abate Giovanna, Maria Amicone, Giovanni Apuzzo, Gennaro Barbuto, Antonio Bassi, Pasquale Boccia, Francesca Borghesi, Alfonso Bosco, Francesco Buono, Tiziana Castellano, Giorgio Chianese, Michele Cicala, Alfonso Ciotta, Secondino Cipriano, Fabrizio G. Crisci, Cristiano Pina, Iris Cupic, Marco De Chiara, Alfonso De Maio, Carlo Del Piano, Chiara Del Prete, Luigi Di Leva, Monica Di Maio, Mauro Di Monte, Alfonso Donnarumma, Enzo Di Stazio, Michele Fabozzi, Maria Gallo, Laura Giordano, Monte Giovanni, Manuela Guerri, Giulia Esposito Iacobitti, Anna Maria La Manna, Gianluca Latte, Fabrizio Lo Iacono, Donato Maietta, Chiara Marano, Maria Federica Finelli, Maria Pasquarella, Mario Acquaviva, Massimo Romanò, Gennaro Mattiello, Pietro Miano, Silvia Migliaccio, Alfredo Mignone, Monte Giovanni, Alfredo Fabio Murano, Simona Oliviero, Teresa Bruna Pagano, Gabriele Palmentola, Salvatore Postiglione, Pvalo Yavorskiy, Raffaela Esposito, Rosario Reggio, B. Riccardi, Eleonora Riccio, Giuseppe Romano, Ersilia Satta, Francesco Antonio Savino, Luisa Scarpati, Domenico Schettino
Abstract
INTRODUCTION: Studies on the durability of an intensive, structured education protocol on best insulin injection practice are missing for people with type 2 diabetes mellitus (T2DM). The aim of this study was to assess the durability of an intensive, structured education-based rehabilitation protocol on best insulin injection practice in well-trained subjects from our previous intensive, multimedia intervention study registered as the ISTERP-1 study. A total of 158 subjects with T2DM from the well-trained group of the 6-month-long ISTERP-1 study, all of whom had successfully attained lower glucose levels compared to baseline levels with lower daily insulin doses and with less frequent and severe hypoglycemic episodes, participated in the present investigation involving an additional 6-month follow-up period, called the ISTERP-2 study. METHODS: Participants were randomized into an intervention group and a control group, depending on whether they were provided or not provided with further education refresher courses for 6 months. At the end of the 6 months, the two groups were compared in terms of injection habits, daily insulin dose requirement, number of severe or symptomatic hypoglycemic events, and glycated hemoglobin (HbA1c) levels. RESULTS: Despite being virtually superimposable at baseline, the two groups behaved quite differently during the follow-up. The within-group analysis of observed parameters showed that the subjects in the intervention group maintained and even improved the good behavioral results learned during the ISTERP-1 study by further reducing both the rate of injection technique errors (p < 0.001) and size of lipohypertrophic lesions at injection sites (p < 0.02). Conversely, those in the control group progressively abandoned best practice, except for the use of ice-cold insulin and, consequently, had significantly higher HbA1c levels and daily insulin dose requirements at the end of the follow-up than at baseline (p < 0.05). In addition, as expected from all the above, the rate of hypoglycemic episodes also decreased in the intervention group (p < 0.05), resulting in a significant difference between groups after 6 months (p < 0.02). CONCLUSION: Our data provide evidence that intensive, structured education refresher courses have no outstanding durability, so that repeated refresher courses, at least at 6-month intervals, are needed to have positive effects on people with T2DM, contributing not only to prevention but also to long-term rehabilitation. TRIAL REGISTRATION: Trial Registration no. 118 bis/15.04.2018.