title: Efficacy of real-time continuous glucose monitoring on glycaemic control and glucose variability in type 1 diabetic patients treated with either insulin pumps or multiple insulin injection therapy: a randomized controlled crossover trial.
abstract: BACKGROUND
  The aim of this study was to determine the efficacy of real-time continuous glucose monitoring in T1D patients treated with insulin pump therapy or multiple daily insulin therapy.
  
  
  METHODS
  Twenty adult patients (ten insulin pump therapy and ten multiple daily insulin) with poor glycaemic control (HbA1c  > 8.0%) were randomized into two groups for 6 months: the continuous glucose monitoring arm (using real-time continuous glucose monitoring) and the SMBG arm. After 2 months of wash-out, the participants crossed over. The primary outcome was HbA1c reduction. The secondary outcomes were hypoglycaemia and hyperglycaemia risk assessment (area under the curve < 70 mg/dL/day and AUC > 200 mg/dL/day, respectively) and glucose variability.
  
  
  RESULTS
  Fourteen patients (eight multiple daily insulin, six insulin pump therapy) used continuous glucose monitoring appropriately (at least 40% of the time). In these patients, the improvement in glycaemic control was more evident during the real-time continuous glucose monitoring period (7.76% ± 0.4 vs 8.54% ± 0.4, p < 0.05) than during the self-monitoring of blood glucose period (8.42% ± 0.4 vs 8.56% ± 0.5, p = 0.2). Better results with continuous glucose monitoring were observed in patients using multiple daily insulin with greater improvement in both glycaemic control (7.71% ± 0.2 vs 8.58% ± 0.2, p < 0.05) and glucose variability and with a marked reduction in the risk of both hypoglycaemia and hyperglycaemia.
  
  
  CONCLUSIONS
  Appropriate use of real-time continuous glucose monitoring improved glycometabolic control in T1D patients. The effects of continuous glucose monitoring were more evident in patients under multiple daily insulin treatment, compared with insulin pump therapy. Glucose variability, in addition to glycaemic control, was improved in compliant diabetic patients.
authors.affiliation: Endocrinology, Department of Clinical and Molecular Biomedicine, University of Catania, Garibaldi-Nesima Hospital, Catania, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Tumminia
authors.forename: Salvatore
authors.initials: S
authors.lastname: Crimi
authors.forename: Laura
authors.initials: L
authors.lastname: Sciacca
authors.forename: Massimo
authors.initials: M
authors.lastname: Buscema
authors.forename: Lucia
authors.initials: L
authors.lastname: Frittitta
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Squatrito
authors.forename: Riccardo
authors.initials: R
authors.lastname: Vigneri
authors.forename: Letizia
authors.initials: L
authors.lastname: Tomaselli
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis* / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007328:Insulin
keywords: CSII; SMBG; T1D; glucose variability; real-time CGM