Variability of Basal Rate Profiles in Insulin Pump Therapy and Association with Complications in Type 1 Diabetes Mellitus

PLoS One. 2016 Mar 3;11(3):e0150604. doi: 10.1371/journal.pone.0150604. eCollection 2016.

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.

Materials and 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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Albuminuria / blood*
  • Albuminuria / etiology
  • Albuminuria / physiopathology
  • Austria
  • Blood Glucose / metabolism
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 1 / physiopathology
  • Diabetic Ketoacidosis / blood*
  • Diabetic Ketoacidosis / etiology
  • Diabetic Ketoacidosis / physiopathology
  • Female
  • Germany
  • Humans
  • Hypoglycemia / blood*
  • Hypoglycemia / etiology
  • Hypoglycemia / physiopathology
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects*
  • Hypoglycemic Agents / blood
  • Hypoglycemic Agents / pharmacokinetics
  • Insulin / administration & dosage
  • Insulin / adverse effects*
  • Insulin / blood
  • Insulin / pharmacokinetics
  • Insulin Coma / blood*
  • Insulin Coma / etiology
  • Insulin Coma / physiopathology
  • Insulin Infusion Systems
  • Logistic Models
  • Male
  • Middle Aged
  • Prospective Studies
  • Registries

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Grants and funding

This study was supported by the BMBF-Kompetenznetz Diabetes mellitus, FKZ 01Gl1106, which is integrated into the German Center for Diabetes Research (DZD) as of January 2015, and by the Austrian Science Fund P 266730. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.