Data from a recent open-label, crossover trial provides clinicians with insight into the safety and efficacy of fully automated closed-loop glucose control versus standard insulin therapy in adults with type 2 diabetes requiring dialysis.
A multinational, randomized crossover trial, results of the study suggest fully automated closed-loop glucose control resulted in improved glucose control and reduce hypoglycemia compared with standard insulin therapy in patients with type 2 diabetes requiring dialysis.
“This study provides evidence that fully closed-loop insulin delivery can improve glucose control and reduce hypoglycemia compared to standard insulin therapy in adults with type 2 diabetes and ESRD requiring dialysis, in an unrestricted home setting,” wrote investigators.
Designed as an open-label, 2-center, randomized, 2-period crossover trial, participants were recruited from dialysis centers and nephrology and diabetes outpatient clinics at Addenbrooke’s Hospital in Cambridge, United Kingdom, and the University Hospital of Bern in Switzerland from October 21, 2019-November 3, 2020.
For inclusion in the trial, patients needed to be at least 18 years of age, have type 2 diabetes requiring subcutaneous insulin therapy, and have end-stage renal failure requiring maintenance dialysis. Patients were excluded If they had type 1 diabetes, were pregnant or breastfeeding, had severe visual or hearing impairment and any physical or psychological disease, or if they were using medications likely to interfere with the trial or results.
Overall, a total of 27 patients participated in the trial, including 17 men and 9 women. The mean age of this cohort was 68±11 years and had a mean diabetes duration of 20±10 years. Investigators noted 1 participant died prior to starting the first treatment arm.
Interventions in the trial were fully closed-loop glucose control using faster-acting insulin aspart and standard multiple daily insulin injection therapy, with each intervention period lasting 20 days and separated by 2-4 weeks of washout using restudy treatment. The primary outcome of interest for the trial was the percentage of time the sensor glucose measurement was in the target glucose range of 5.6–10.0 mmol/L during the 20-day study period.
Results of the study demonstrated the portion of time in target glucose range was 52.8 ± 12.5% with fully automated closed-loop glucose control and 37.7 ± 20.5% with standard insulin therapy (mean difference, 15.1 [95% CI, 8.0-22.2; P < .001]). Assessments of mean glucose indicated mean glucose was lower with closed-loop glucose control than standard insulin therapy (10.1±1.3 vs 11.6±2.8 mmol/ L; P= .003). Similarly, time in hypoglycemia was lower with closed-loop control than with standard insulin therapy (median, 0.1 [IQR, 0.0–0.4%] vs 0.2 [0.0–0.9%]; P= .040). There were no severe hypoglycemia events observed with standard insulin therapy, but a single event occurred during treatment with closed-loop therapy. Investigators pointed out this event did not take place not during closed-loop operation.
In their conclusion, investigators noted the need for further research assessing use of closed-loop glucose control in subgroups of patients with type 2 diabetes.
“Having demonstrated safety and efficacy in this at-risk population in this exploratory study, larger studies are now required to confirm these findings and to determine if the glycemic improvements observed with closed-loop are associated with a reduction in complications and improved quality of life, as well as whether closed-loop should be targeted towards specific subpopulations,” wrote investigators.
This study, “Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial,” was published in Nature Medicine.