1. Participants using the novel advanced hybrid insulin delivery system (Medtronic) had a greater proportion of time spent in their target glucose range versus control.
2. Proportion of time spent in hypoglycemic ranges was non-inferior between the Medtronic and control groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Although various technological advances have improved the management of Type 1 Diabetes, proper monitoring of blood sugar and insulin administration remains a constant challenge. More recent devices in the USA, such as the MiniMed 670G, are hybrid closed-loop systems that use automated insulin delivery to improve blood sugar management; however, studies have shown that even with this, patients can miss their target glucose range by as much as 30% of the time. The novel advanced hybrid closed-loop system, the Medtronic system, seeks to improve this shortcoming using advanced algorithms and monitoring. This open-label, randomized crossover trial sought to compare the commercially available MiniMed 670G system with the novel Medtronic device in young adults with type 1 diabetes. Overall, participants using the Medtronic device had a greater proportion of time spent in their target blood glucose range over a 24h period. They also demonstrated moderately lower levels of HbA1c over this period. Participants also reported a higher rating of satisfaction with the use of the Medtronic device. Overall, this study provides strong evidence for the use of the new Medtronic device. Its use of a crossover design, with benefits for the new device evident in both groups, is a particular strong point. However, a notable limitation is the short study duration (3 months), as it is well known that blood glucose management can fluctuate significantly over the course of months or years for diabetics.
In-Depth [randomized controlled trial]: This open-label, randomized crossover trial occurred at seven institutions across the USA, Germany, Israel and Slovenia. Eligible participants were young adults aged 14-29 years with type 1 diabetes on insulin pump or multiple daily injections. Over a total of two periods of 12 weeks, participants were randomly assigned to either the MiniMed or Medtronic group, and then crossed over to utilize the other device. The coprimary outcomes of this study were proportion of time spent with glucose levels over 180 mg/dL between daytime hours of 06:00-23:59h, as well as proportion of time spent with glucose levels below 54 mg/dL in a 24h period. A total of 113 participants were randomized into the two crossover groups; 56 began with the Medtronic and 57 with the MiniMed system, respectively. Average proportion of time with glucose levels >180 mg/dL between 06:00-23:59h was lower in the novel Medtronic group (34% vs 37%; mean difference = -3.00% [95% CI -3.96 to 2.04]; p<0.0001 for superiority). Additionally, average proportion of time with glucose levels <54 mg/dL over 24h was lower during Medtronic device use (0.46% vs 0.50%; mean difference= -0.06% [95% CI -0.11% to -0.02%]; p<0.0001 for non-inferiority). Overall, participants in the Medtronic group spent more time in the target glucose range of 70-180 mg/dL (67% Medtronic vs. 63% MiniMed) and had lower mean HbA1c levels (7.4% Medtronic vs. 7.6% MiniMed, p=0.026).
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