title: Treatment intensification using long-acting insulin -predictors of future basal insulin supported oral therapy in the DIVE registry.
abstract: BACKGROUND
  In patients with type-2 diabetes receiving oral antidiabetic drugs (OADs), the addition of insulin is frequently required to achieve sufficient control over blood glucose levels. It is, however, difficult to predict if, when and in which patients insulin therapy will be needed. We aimed to identify patient related variables associated with the addition of basal insulin to oral therapy resulting in a basal supported oral therapy (BOT).
  
  
  METHODS
  DIVE (DIabetes Versorgungs-Evaluation) is a prospective, observational, multi-centre diabetes registry established in Germany in 2011. For the present explorative analysis, 31,008 patients with type-2 diabetes prescribed at least one OAD were included. Patients who had previously received insulin and those over 90 years old were excluded. The event of interest was defined as the initiation of BOT during the observational period. Cause-specific Cox proportional hazards models based on a competing risk framework were applied for risk quantification.
  
  
  RESULTS
  Multivariable adjusted hazard ratios demonstrated that longer diabetes duration, higher BMI, poorer glycaemic control, documentation of any micro- or macrovascular comorbidity, the presence of concomitant non-antidiabetic pharmacotherapies, and greater numbers of prescribed OADs increased the likelihood of BOT initiation. On the other hand BOT initiation was less likely in patients with older age and female gender. Analysing the likelihood of OAD termination without initiation of BOT provided supportive evidence for the variables predictive of BOT initiation.
  
  
  CONCLUSIONS
  Analysis of the DIVE registry has resulted in the identification of a number of factors that may be predictive for the initiation of BOT for type-2 diabetes patients initially prescribed one or more OADs. Poor glycaemic control, the presence of vascular comorbidities and concomitant medications, and a greater number of OADs were all detected to increase the risk of a switch to BOT. Female gender and younger age showed protective properties.
  
  
  CONCLUSIONS
  The close monitoring of patients displaying these characteristics may help to identify individuals who might benefit from early addition of insulin therapy to their oral treatment regimen.
authors.affiliation: Kinder- und Jugendkrankenhaus "AUF DER BULT", Hannover, Germany. danne@hka.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Danne
authors.affiliation: Institute of Statistics, University of Ulm, Ulm, Germany. tobias.bluhmki@uni-ulm.de.
authors.forename: Tobias
authors.initials: T
authors.lastname: Bluhmki
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg, Freiburg, Germany. jochen.seufert@uniklinik-freiburg.de.
authors.forename: Jochen
authors.initials: J
authors.lastname: Seufert
authors.affiliation: Gemeinschaftspraxis Kaltheuner - v. Boxberg, Leverkusen, Germany. m.kaltheuner@web.de.|winDiab GmbH, Kehler Straße 24, 40468, Düsseldorf, Germany. m.kaltheuner@web.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Kaltheuner
authors.affiliation: Institut für Biometrie und Epidemiologie, Deutsches Diabetes Zentrum Düsseldorf, Düsseldorf, Germany. rathmann@ddfi.uni-duesseldorf.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rathmann
authors.affiliation: Institute of Statistics, University of Ulm, Ulm, Germany. jan.beyersmann@uni-ulm.de.
authors.forename: Jan
authors.initials: J
authors.lastname: Beyersmann
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Mahlow, Germany. peter.bramlage@ippmed.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D000284:Administration, Oral; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin