title: Variability of Basal Rate Profiles in Insulin Pump Therapy and Association with Complications in Type 1 Diabetes Mellitus.
abstract: BACKGROUND
  Traditionally, basal rate profiles in continuous subcutaneous insulin infusion therapy are individually adapted to cover expected insulin requirements. However, whether this approach is indeed superior to a more constant BR profile has not been assessed so far. This study analysed the associations between variability of BR profiles and acute and chronic complications in adult type 1 diabetes mellitus.
  
  
  METHODS
  BR profiles of 3118 female and 2427 male patients from the "Diabetes-Patienten-Verlaufsdokumentation" registry from Germany and Austria were analysed. Acute and chronic complications were recorded 6 months prior and after the most recently documented basal rate. The "variability index" was calculated as variation of basal rate intervals in percent and describes the excursions of the basal rate intervals from the median basal rate.
  
  
  RESULTS
  The variability Index correlated positively with severe hypoglycemia (r = .06; p<0.001), hypoglycemic coma (r = .05; p = 0.002), and microalbuminuria (r = 0.05; p = 0.006). In addition, a higher variability index was associated with higher frequency of diabetic ketoacidosis (r = .04; p = 0.029) in male adult patients. Logistic regression analysis adjusted for age, gender, duration of disease and total basal insulin confirmed significant correlations of the variability index with severe hypoglycemia (β = 0.013; p<0.001) and diabetic ketoacidosis (β = 0.012; p = 0.017).
  
  
  CONCLUSIONS
  Basal rate profiles with higher variability are associated with an increased frequency of acute complications in adults with type 1 diabetes.
authors.affiliation: Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Bern, Bern, Switzerland.|Department of Internal Medicine I, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Laimer
authors.affiliation: Department of Internal Medicine I, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Melmer
authors.affiliation: Department of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria.
authors.forename: Julia K
authors.initials: JK
authors.lastname: Mader
authors.affiliation: Medical Department of Metabolic Disease and Nephrology, Hospital Hitzing, Vienna, Austria.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Schütz-Fuhrmann
authors.affiliation: Vivantes Clinics Hellersdorf, Berlin, Germany.
authors.forename: Heide-Rose
authors.initials: HR
authors.lastname: Engels
authors.affiliation: Diabetes Centre Nürtingen, Clinics Esslingen, Baden-Württemberg, Germany.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Götz
authors.affiliation: Department of Internal Medicine, Hospital Tettnang, Baden-Württemberg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Pfeifer
authors.affiliation: Institute of Epidemiology and Medical Biometry, ZIBMT, German Center for Diabetes Research (DZD), University of Ulm, Ulm, Germany.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Hermann
authors.affiliation: Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Bern, Bern, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Stettler
authors.affiliation: Institute of Epidemiology and Medical Biometry, ZIBMT, German Center for Diabetes Research (DZD), University of Ulm, Ulm, Germany.
authors.forename: Reinhard W
authors.initials: RW
authors.lastname: Holl
mesh_terms: D000293:Adolescent; D000328:Adult; D000419:Albuminuria / Q000097:blood* / Q000209:etiology / Q000503:physiopathology; D001317:Austria; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D016883:Diabetic Ketoacidosis / Q000097:blood* / Q000209:etiology / Q000503:physiopathology; D005260:Female; D005858:Germany; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000209:etiology / Q000503:physiopathology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics; D007331:Insulin Coma / Q000097:blood* / Q000209:etiology / Q000503:physiopathology; D007332:Insulin Infusion Systems; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin