title: Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes.
abstract: BACKGROUND
  Published evaluations of sensor glucose monitoring use in insulin treated type 2 diabetes are limited. The aim of this study was to assess the impact of flash glucose-sensing technology as a replacement for self-monitoring of blood glucose (SMBG) over a 12-month period in participants with type 2 diabetes who were on intensive insulin therapy.
  
  
  METHODS
  An open-label, randomized, controlled study in adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers aimed at assessing flash glucose sensing technology was conducted. Participants (N = 224) were randomized (1:2 respectively) to a control group (n = 75) that used SMBG (FreeStyle Lite™) or to an intervention group (n = 149) which used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management over 6 months. All intervention group participants who completed the 6-month treatment phase continued into an additional 6-month open-access phase.
  
  
  RESULTS
  A total of 139 intervention participants completed the 6-month treatment phase and continued into the open-access phase. At 12 months (end of open-access period), time in hypoglycemia [sensor glucose <3.9 mmol/L (70 mg/dL)] was reduced by 50% compared to baseline [-0.70 ± 1.85/24 h (mean ± standard deviation); p = 0.0002]. Nocturnal hypoglycemia [2300 to 0600 hours, <3.9 mmol/L (70 mg/dL)] was reduced by 52%; p = 0.0002. There was no change in time in range [sensor glucose 3.9-10.0 mmol/L (70-180 mg/dL)]. SMBG testing fell from a mean of 3.9 (median 3.9) times/day at baseline to 0.2 (0.0), with an average frequency of sensor scanning of 7.1 (5.7) times/day at 12 months, and mean sensor utilization was 83.6 ± 13.8% (median 88.3%) during the open-access phase. During this 6-month extension period no device-related serious adverse events were reported. Nine participants reported 16 instances of device-related adverse events (e.g. infection, allergy) and 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms/sensor-insertion events expected with device use (e.g. erythema, itching and rash).
  
  
  CONCLUSIONS
  The use of flash glucose-sensing technology for glycemic management in individuals with type 2 diabetes treated by intensive insulin therapy over 12 months was associated with a sustained reduction in hypoglycemia and safely and effectively replaced SMBG.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT02082184.
authors.affiliation: Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany. haak@diabetes-zentrum.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Haak
authors.affiliation: Department of Diabetology, Metabolic Diseases, and Nutrition, CHU Toulouse, University of Toulouse, Toulouse, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Hanaire
authors.affiliation: Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
authors.forename: Ramzi
authors.initials: R
authors.lastname: Ajjan
authors.affiliation: Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: Department of Diabetes and Endocrinology, University of Paris-Diderot, Paris 7, Paris, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Riveline
authors.affiliation: The Diabetes Centre, Ipswich Hospital NHS Trust, Ipswich, Suffolk, UK.
authors.forename: Gerry
authors.initials: G
authors.lastname: Rayman
keywords: Flash sensor glucose technology; Glucose monitoring; Insulin; Type 2 diabetes