title: Evaluation of a clinical tool to test and adjust the programmed overnight basal profiles for insulin pump therapy: a pilot study.
abstract: OBJECTIVE
  Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia.
  
  
  METHODS
  We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values <4.0 mmol/L), and glycated hemoglobin (A1C) were compared.
  
  
  RESULTS
  Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD12-7am and IQR12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03).
  
  
  CONCLUSIONS
  The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Andrej
authors.initials: A
authors.lastname: Orszag
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: C Marcelo
authors.initials: CM
authors.lastname: Falappa
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Leif E
authors.initials: LE
authors.lastname: Lovblom
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Helen
authors.initials: H
authors.lastname: Partridge
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Holly
authors.initials: H
authors.lastname: Tschirhart
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Genevieve
authors.initials: G
authors.lastname: Boulet
authors.affiliation: Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, Ontario, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Picton
authors.affiliation: Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Cafazzo
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: BPerkins@mtsinai.on.ca.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perkins
mesh_terms: D000328:Adult; D001786:Blood Glucose; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation / Q000379:methods*; D010865:Pilot Projects
chemical_list: D001786:Blood Glucose
keywords: basal insulin assessment; continuous glucose monitoring; continuous subcutaneous insulin infusion; diabète de type 1; estimation de l’insuline basale; insulin pump therapy; perfusion sous-cutanée continue d’insuline; surveillance de la glycémie en continu; thérapie par pompe à insuline; type 1 diabetes