title: The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial.
abstract: OBJECTIVE
  The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes.
  
  
  METHODS
  Children and adults (n = 153) on CSII with HbA(1c) 7.5-9.5% (58.5-80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months' washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA(1c) levels between arms after 6 months.
  
  
  RESULTS
  Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA(1c) was -0.43% (-4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI -0.32%, -0.55% [-3.50, -6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA(1c) reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40).
  
  
  CONCLUSIONS
  Continuous glucose monitoring was associated with decreased HbA(1c) levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.
authors.affiliation: UMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si
authors.forename: T
authors.initials: T
authors.lastname: Battelino
authors.forename: I
authors.initials: I
authors.lastname: Conget
authors.forename: B
authors.initials: B
authors.lastname: Olsen
authors.forename: I
authors.initials: I
authors.lastname: Schütz-Fuhrmann
authors.forename: E
authors.initials: E
authors.lastname: Hommel
authors.forename: R
authors.initials: R
authors.lastname: Hoogma
authors.forename: U
authors.initials: U
authors.lastname: Schierloh
authors.forename: N
authors.initials: N
authors.lastname: Sulli
authors.forename: J
authors.initials: J
authors.lastname: Bolinder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015374:Biosensing Techniques; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood* / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin