title: An algorithm guiding patient responses to real-time-continuous glucose monitoring improves quality of life.
abstract: OBJECTIVE
  This study evaluated the impact on quality of life (QoL) of an algorithm guiding the responses of continuous subcutaneous insulin infusion (CSII)-treated type 1 diabetes (T1D) patients using real-time (RT)-continuous glucose monitoring (CGM).
  
  
  METHODS
  Sixty CSII-treated T1D participants (13-70 years old, glycosylated hemoglobin [HbA1c] ≤ 9.5%), including adult and adolescent subgroups, were randomized in age-, gender-, and HbA1c-matched pairs. Phase 1 was an open 16-week multicenter randomized controlled trial; Group A received CSII/RT-CGM with the algorithm, and Group B received CSII/RT-CGM without algorithm. Phase 2 was the 16-32-week follow-up study; Group A returned to usual care (CSII without RT-CGM), and Group B was provided with algorithm at 16 weeks. QoL was assessed by DQOL (adults) and DQOLY (adolescents) questionnaires at baseline, 16 weeks, and 32 weeks. Higher scores (range 1-5) indicate poorer QoL. Analysis was by analysis of variance (between group for baseline-16 weeks) and paired two-tailed t tests (within group for baseline and 32 weeks) with significance at P < 0.05.
  
  
  RESULTS
  Withdrawals left 28 of 30 patients in Group A and 27 of 30 patients in Group B at 32 weeks. In Phase 1, QoL in Group A (2.16 [0.44] baseline to 1.86 [0.40] at 16 weeks) improved compared with Group B (2.03 [0.47] to 2.03 [0.50]) (P = 0.002). Change in QoL correlated with changes in HbA1c (R = 0.36; P = 0.007). In Phase 2, Group A QoL was better at 32 weeks compared with baseline (2.16 [0.44] vs. 2.02 [0.43]) (P = 0.04) but was not in Group B (2.03 [0.47] vs. 1.99 [0.51]) (P = not significant).
  
  
  CONCLUSIONS
  An algorithm guiding CSII-treated T1D responses to RT-CGM improved QoL, which persisted post-RT-CGM withdrawal. Algorithm provision at RT-CGM initiation was required to benefit QoL.
authors.affiliation: University of Melbourne Department of Medicine, St. Vincent's Hospital, Fitzroy, Australia.
authors.forename: Alicia J
authors.initials: AJ
authors.lastname: Jenkins
authors.forename: Balasubramanian
authors.initials: B
authors.lastname: Krishnamurthy
authors.forename: James D
authors.initials: JD
authors.lastname: Best
authors.forename: Fergus J
authors.initials: FJ
authors.lastname: Cameron
authors.forename: Peter G
authors.initials: PG
authors.lastname: Colman
authors.forename: Peter S
authors.initials: PS
authors.lastname: Hamblin
authors.forename: Michele A
authors.initials: MA
authors.lastname: O'Connell
authors.forename: Christine
authors.initials: C
authors.lastname: Rodda
authors.forename: Helena
authors.initials: H
authors.lastname: Teede
authors.forename: David N
authors.initials: DN
authors.lastname: O'Neal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D001315:Australia; D001786:Blood Glucose / Q000032:analysis*; D003661:Decision Support Techniques; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D010352:Patient Dropouts; D010353:Patient Education as Topic; D011788:Quality of Life; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human