A 1-year observational follow-up of a 3-month randomized controlled trial provides insight into the benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose.
This article was originally published by HCPLive®.
A study of adults with type 1 diabetes naive to advanced diabetes technology is underlining the potential benefit of newer technologies in diabetes management.
Results of the study, which examined quality of life over 1-year after initiating use of an advanced hybrid closed-loop system, suggest use of diabetes technology was associated with notable improvements in quality of life.1
“To the best of our knowledge, this is the first long-term follow-up study investigating the psychological well-being of adult people with T1D previously naïve to diabetes technology (treated with [multiple daily injections] and [self-monitoring of blood glucose]) who experience a direct switch to the [advanced hybrid closed loop] system with novel calibration-free sensors, and the sustainability of the obtained changes in their quality of life,” wrote investigators.1
As the rate of advancement and endorsement among guidelines for diabetes technology continues to progress, optimal uptake of new technologies has become a focal point of research for many within the community. The current study was designed by a team of investigators from institutions in Poland led by Katarzyna Cyranka, PhD, MA, of the University Hospital in Krakow, as a 9-month observational continuation of a 3-month randomized controlled trial, with the aim of exploring the effect of 1-year of use of an advanced hybrid closed-loop system on quality of life, level of anxiety, and self-efficacy.1
In the original trial, 41 patients were randomized to advanced hybrid closed loop therapy with the MiniMed 780G advanced hybrid closed-loop system or to remain on multiple daily injections and self-monitoring of blood glucose. Overall, 20 and 21 patients were randomized to the intervention and control arm, respectively.2
A total of 37 patients completed the study. At 3 months, time in range increased from 69.3% (SD, 12.3) at baseline to 85.0% (SD, 6.3) at 3 months in the advanced hybrid group, while remaining unchanged in the control group (treatment effect 21.5% [95% CI 15.727.3]; P < 0.001).2
From the original study, 18 participants from the intervention group continued use in the 9-month observational continuation period. This cohort consisted of 10 men and 8 women, with a mean age of 40.9 (SD, 7.6) years. Of note, at month 6 of the study, patients were switched from the Guardian Sensor 3 to the Guardian Sensor 4 Continuous Glucose Monitoring system.1
The primary outcomes of interest for the trial were change in quality of life, level of anxiety, and level of self-efficacy. Investigators pointed out quality of life was assessed using the Polish validated version of the ‘QoL-Q Diabetes’ questionnaire, level of anxiety was assessed using the State-Trait Anxiety Inventory (STAI), and self-efficacy was assessed using the General Self-Efficacy Scale (GSES).1
Upon analysis, results pointed to significant increases in quality of life for the global QOL-Q Diabetes questionnaire score, with significant increases observed in as many as 11 of 23 areas of life. These areas included being physically active (P = .02; Cohen d = .71), feeling well (P <.01; Cohen d = 0.73), feeling in control of my body (P <.01; Cohen d = 0.72), looking good (P <.01; Cohen d = 1.07), working (P <.01; Cohen d = 1.12); sleeping (P = .01, Cohen d = .66), eating as I would like (P <.01; Cohen d = .79), looking after or being useful to others (P = .02; Cohen d = 0.65), being active with pets/animals (P <.01; Cohen d = .95), being spontaneous (P = .02; Cohen d = .67), and doing “normal” things (P = .02; Cohen d = .67).1
Further analysis revealed use of the advanced hybrid closed-loop system was also associated with improvements in both state (P = .04; Cohen d = .56) and trait (P = .02; Cohen d = .60) anxiety as well as self-efficacy (P = .03; Cohen d = .76). Investigators also pointed out there were no instances of pump discontinuation during the study.1
“Evaluation of patients’ [quality of life] is a well-grounded indicator of the effectiveness of provided healthcare and may be helpful for health professionals and healthcare policymakers in their efforts to improve the well-being of patients,” wrote investigators.1