An Algorithm Guiding Patient Responses to Real-Time-Continuous Glucose Monitoring Improves Quality of Life

作者：Jenkins Alicia J; Krishnamurthy Balasubramanian; Best James D; Cameron Fergus J; Colman Peter G; Hamblin Peter S; O'Connell Michele A; Rodda Christine; Teede Helena; O'Neal David N^*

来源：Diabetes Technology & Therapeutics, 2011, 13(2): 105-109.

DOI：10.1089/dia.2010.0139

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).
Research Design and 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.

• 出版日期2011-2