title: Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia.
abstract: OBJECTIVE
  Insulin pump therapy associated with continuous glucose monitoring has shown a positive clinical impact on diabetes control and reduction of hypoglycemia episodes. There are descriptions of the performance of this device in other populations, but its precision and accuracy in Colombia and Latin America are unknown, especially in the routine outpatient setting.
  
  
  METHODS
  Data from 33 type 1 and type 2 diabetes patients with sensor-augmented pump therapy with threshold suspend automation, MiniMed Paradigm® Veo™ (Medtronic, Northridge, California), managed at Hospital Universitario San Ignacio (Bogotá, Colombia) and receiving outpatient treatment, were analyzed. Simultaneous data from continuous glucose monitoring and capillary blood glucose were compared, and their precision and accuracy were calculating with different methods, including Clarke error grid.
  
  
  RESULTS
  Analyses included 2,262 continuous glucose monitoring -reference paired glucose values. A mean absolute relative difference of 20.1% was found for all measurements, with a value higher than 23% for glucose levels ≤75mg/dL. Global compliance with the ISO criteria was 64.9%. It was higher for values >75mg/dl (68.3%, 1,308 of 1,916 readings), than for those ≤ 75mg/dl (49.4%, 171 of 346 readings). Clinical accuracy, as assessed by the Clarke error grid, showed that 91.77% of data were within the A and B zones (75.6% in hypoglycemia).
  
  
  CONCLUSIONS
  A good numerical accuracy was found for continuous glucose monitoring in normo and hyperglycemia situations, with low precision in hypoglycemia. The clinical accuracy of the device was adequate, with no significant safety concerns for patients.
authors.affiliation: Unidad de Endocrinología, Departamento de Medicina Interna, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Gómez
authors.affiliation: Unidad de Endocrinología, Departamento de Medicina Interna, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Marín Sánchez
authors.affiliation: Departamento de Medicina Interna, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Bogotá, Colombia. Electronic address: o.munoz@javeriana.edu.co.
authors.forename: Oscar M
authors.initials: OM
authors.lastname: Muñoz
authors.affiliation: Unidad de Endocrinología, Departamento de Medicina Interna, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio.
authors.forename: Christian Alejandro
authors.initials: CA
authors.lastname: Colón Peña
mesh_terms: D000328:Adult; D001331:Automation; D015374:Biosensing Techniques; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods*; D002196:Capillaries; D056902:Clinical Alarms; D003105:Colombia; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015918:Infusion Pumps, Implantable; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008875:Middle Aged; D010349:Patient Compliance; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Bomba de insulina; Continuous glucose monitoring; Diabetes tipo 1; Diabetes tipo 2; Insulin pump; Monitorización continua de glucosa; Type 1 diabetes mellitus; Type 2 diabetes mellitus