title: How to Assess the Quality of Glucose Clamps? Evaluation of Clamps Performed With ClampArt, a Novel Automated Clamp Device.
abstract: BACKGROUND
  There are no widely accepted parameters to assess the quality of glucose clamps. Thus, we selected different parameters describing clamp quality. These parameters were then evaluated in glucose clamps carried out with ClampArt, a novel CE-marked, state-of-the-art fully automated glucose clamp device employing continuous blood glucose (BG) measurements and minute-by-minute adaptations of glucose infusion rate (GIR).
  
  
  METHODS
  Thirty-nine glucose clamps were performed in 10 healthy and 29 subjects with type 1 diabetes (T1DM) (total duration 583 h). ClampArt-based BG measurements were compared with those obtained with a laboratory reference method. Clamp quality was assessed by 5 parameters: (1) difference (mg/dl) of all paired BG measurements of ClampArt versus reference method ("trueness"), (2) coefficient of variation (CV, %) of ClampArt's BG measurements at target clamp level ("precision"), (3) mean absolute relative difference (MARD, %) at target clamp level ("accuracy"), (4) difference (mg/dl) between ClampArt and target BG ("control deviation"), and (5) percentage operational time ("utility").
  
  
  RESULTS
  ClampArt-based BG measurements showed a trueness of 1.2 ± 2.5 mg/dl. CV and MARD at target BG were 5.5 ± 2.1% and 5.3 ± 2.3%, respectively. There were only small deviations from target level (1.2 ± 1.6 mg/dl). Operational time was as high as 95.4% ± 4.1% (means ± SD).
  
  
  CONCLUSIONS
  The selected parameters seem to be adequate to characterize clamp quality. The novel, fully automated clamp device ClampArt achieves high clamp quality, which in future trials should be compared with other (automated and manual) clamp methods.
authors: Profil, Neuss, Germany.
authors: Carsten
authors: C
authors: Benesch
authors: Profil, Neuss, Germany.
authors: Tim
authors: T
authors: Heise
authors: Profil, Neuss, Germany.
authors: Oliver
authors: O
authors: Klein
authors: Profil, Neuss, Germany.
authors: Lutz
authors: L
authors: Heinemann
authors: Profil, Neuss, Germany sabine.arnolds@profil.com.
authors: Sabine
authors: S
authors: Arnolds
mesh_terms: D000328:Adult; D001331:Automation; D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis; D004867:Equipment Design; D005260:Female; D015309:Glucose Clamp Technique; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation* / Q000379:methods; D011787:Quality of Health Care; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: ClampArt; glucose clamp; pharmacodynamics; type 1 diabetes