title: Performance of the continuous glucose monitoring system (CGMS) during development of ketosis in patients on insulin pump therapy.
abstract: OBJECTIVE
  Ketoacidosis is one of the most severe complications of Type 1 diabetes. Development of ketosis leads to substantial shifts in electrolyte and ion concentrations in the different fluid compartments of the body. This study was performed to investigate the performance of the continuous glucose monitoring device (CGMS) during ketoacidosis.
  
  
  METHODS
  Twelve patients with Type 1 diabetes using continuous subcutaneous insulin infusion (CSII) participated in this trial [10 women, two men; age (mean +/- sd) 34 +/- 9 years; disease duration 17 +/- 10 years; HbA(1c) 7.1 +/- 1.0%]. In the morning, patients ate breakfast and the insulin pump was stopped at 11.00 h and restarted after 8 h. Observation parameters during this experiment were: blood glucose (laboratory reference and CGMS), 3-hydroxy-butyrate (3-OHB), pH, Na, pCO(2), pO(2), free fatty acids, osmolarity, standard bicarbonate, and lactate.
  
  
  RESULTS
  Blood glucose increased and reached a plateau within 2 h after pump stop (from 6.2 +/- 2.56 to 16.7 +/- 4.44 mmol/l, P < 0.001). A constant increase in 3-OHB (from 0.0 to 0.8 +/- 0.5 mmol/l, P < 0.001) and decrease in pH (from 7.43 +/- 0.02 to 7.40 +/- 0.03, P < 0.05) indicated ketosis development. Na decreased from 141 +/- 1.4 to 138 +/- 2.8 mmol/l, P < 0.001). Free fatty acids increased from 0.577 +/- 0.330 to 1.330 +/- 0.462 mmol/l (P < 0.001). The CGMS values showed excellent agreement with the capillary blood laboratory method during the entire experiment, and a modified error grid analysis revealed that 99.5% of the values were in the clinically acceptable zones A and B.
  
  
  CONCLUSIONS
  The CGMS device was confirmed to be reliable and accurate during the development of hyperglycaemia and ketotic conditions.
authors.affiliation: IKFE-Institute for Clinical Research and Development, Mainz, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Pfützner
authors.forename: T
authors.initials: T
authors.lastname: Forst
authors.forename: R
authors.initials: R
authors.lastname: Butzer
authors.forename: S
authors.initials: S
authors.lastname: Forst
authors.forename: M M
authors.initials: MM
authors.lastname: Weber
authors.forename: A H
authors.initials: AH
authors.lastname: Pfützner
authors.forename: A
authors.initials: A
authors.lastname: Pfützner
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis* / Q000188:drug therapy*; D016883:Diabetic Ketoacidosis / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin