title: InDuo, a novel combined insulin injection and blood glucose monitoring device - effective and save as other devices, and patient preference.
abstract: OBJECTIVE
  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.
  
  
  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(R) (i. e., for insulin dosage and for blood glucose readings) were used by more than 70 % of the patients.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medizinische Klinik IV, Uniklinikum Tübingen, Germany. Axel.Haupt@med.uni-tuebingen.de
authors.forename: A
authors.initials: A
authors.lastname: Haupt
authors.forename: B
authors.initials: B
authors.lastname: Berg
authors.forename: P
authors.initials: P
authors.lastname: Paschen
authors.forename: M
authors.initials: M
authors.lastname: Dreyer
authors.forename: H-U
authors.initials: HU
authors.lastname: Häring
authors.forename: J
authors.initials: J
authors.lastname: Smedegaard
authors.forename: S E
authors.initials: SE
authors.lastname: Skovlund
authors.forename: S
authors.initials: S
authors.lastname: Matthaei
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000628:therapy*; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged
chemical_list: D001786:Blood Glucose