InDuo®, a Novel Combined Insulin Injection and Blood Glucose Monitoring Device - Effective and Save as Other Devices, and Patient Preference

Abstract

Background and Aim: Frequent blood glucose (BG) monitoring and insulin administration are necessary in intensive insulin regimes. A new integrated system, InDuo® is a compact and portable combined insulin doser and BG monitor, designed to overcome some of the limitations of current insulin therapy. The aim of the study was to compare InDuo® and a non-integrated system (HumaPen® Ergo and Accu-Chek® Sensor Meter) for efficacy and safety, and to evaluate patients preference. Materials and Methods: The trial design was a multicentre, randomised, 12-week, open-label, comparative, two period crossover. One hundred and ten patients with diabetes, treated with a basal bolus regime, were included. The subjects were assigned to use either InDuo® or the non-integrated system. After six weeks of treatment, the subjects were transferred to the alternative system. To assess efficacy, fasting plasma glucose (FBG), 7-point blood glucose profile, serum fructosamine and HbA1c were measured. Serum fructosamine and FBG were measured at baseline and at six and 12 weeks; HbA1c was measured at baseline and week 12. Safety endpoints were number and severity of hypoglycaemic episodes, adverse events and adverse device effects. Patient preference was assessed by a comparative device questionnaire at 12 weeks. Results: Analysis with an ANOVA mixed model showed no difference after each treatment between serum fructosamine or between FBG levels. HbA1c decreased during the trial from 7.5 % ± 1.2 to 7.1 % ± 0.8 at 12 weeks. The safety profiles were similar for both treatments for hypoglycaemic episodes. The incidence of adverse events was also similar. There were 10 adverse device effects reported: eight for the Innovo® device in the InDuo®, one for the InDuo® device and one for the Accu-Chek® Sensor Meter. The comparative device questionnaire at 12 weeks showed patients strongly preferred InDuo® to HumaPen® Ergo and Accu-Chek® Sensor Meter (all p < 0.0001). Of those preferring InDuo®, more than 60 % classified their choice as very or extremely strong. Both memory functions in InDuo® (i. e., for insulin dosage and for blood glucose readings) were used by more than 70 % of the patients. Conclusion: Treatment with the InDuo® system was as effective and safe as treatment with the non-integrated system. Almost 75 % preferred using InDuo® to the non-integrated HumanPen® Ergo and Accu-Chek® Sensor Meter.

Key words

InDuo® - patient preference - diabetes - blood glucose monitoring devices

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