Advanced Hybrid Closed-Loop System Helps Achieve T1D Glucose Targets in New Trial

The trial followed patients with type 1 diabetes (T1D) for 6 months, evaluating outcomes in patients struggling to achieve glucose targets with the conventional treatment.

Researchers of a new European study are advocating for expanded access to advanced hybrid closed-loop (AHCL) systems in patients with type 1 diabetes based on their study findings that showed that the approach could aid in achieving glycemic control.

The Advanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes included 82 patients randomized to AHCL use or to continue conventional treatment with multiple daily insulin injections plus continuous glucose monitoring (CGM). The prospective, multicenter, open-label trial followed patients for 6 months, finding that the closed-loop system improved outcomes in patients struggling to achieve glucose targets with the conventional treatment.

Findings were published in Lancet Diabetes and Endocrinology.

“Glycemic control is established as a key determinant of the risk for long­term microvascular and cardiovascular complications in type 1 diabetes. As such, it is feasible that if the improved glycemic control observed with AHCL [systems] can be sustained over the long term, the use of AHCLs could have benefits in terms of reducing the risk for long­term complications,” the authors wrote. “Moreover, there is some suggestion that achieving good glycemic control early in the course of disease could be particularly beneficial in terms of the effects on long­term complication risk.”

Data on the primary end point—between­group difference in mean change in hemoglobin A1C (HbA1C) from baseline to 6 months—showed a model­based treatment effect of –1.42% (95% CI, –1.74 to –1.10; –15.5 mmol/mol; 95% CI, –19.0 to –12.0; P < .0001) associated with AHCL use relative to conventional treatment. By 6 months, patients receiving the AHCL system had a mean HbA1c decrease of 1.54% compared with a 0.20% decrease among patients receiving conventional treatment.

AHCL also led to a greater percentage of time spent in target range (70-180 mg/dL), the study’s secondary end point, compared with conventional treatment (70.6% vs 43.6%, respectively). The closed-loop system was associated with a mode-based treatment effect of 27.6% relative to conventional treatment. According to the researchers, this was largely attributable to a decrease in time above range; patients in the AHCL group spent a mean of 6.6% of the time with levels over 250 mg/dL and 26.7% of the time with levels over 180 mg/dL vs 22.5% and 53.8% of time, respectively, among the conventional treatment group.

During the 6 months of treatment, there were no reports of severe hypoglycemia or diabetic ketoacidosis. There were 2 severe hypoglycemic events during the 2-week run-in phase and 15 device-related nonserious adverse events that occurred among patients receiving AHCL systems compared with 3 events among patients receiving conventional treatment.

“Although the participants underwent a shift in the therapeutic approach—from multiple daily injections of insulin plus isCGM [intermittently scanned CGM] to an integrated AHCL system— analysis of safety data showed an overall low incidence of serious adverse events and no serious adverse device effects, diabetic ketoacidosis, or severe hypoglycaemic events,” the investigators wrote. “This finding could help to alleviate concerns that people treating themselves with multiple daily injections of insulin can find it challenging to adapt to new technologies, which has formed part of the rationale for a stepped­care approach that has culminated in the delayed adoption of advanced technologies.”

Patient-reported outcomes were also collected throughout the study, and these showed that improvements were seen with both treatment approaches, although AHCL use was associated with improved satisfaction with treatment and improvement in fear of hypoglycemia relative to conventional treatment.

Reference

Choudhary P, Kolassa R, Keuthage W, et al. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. Published online September 1, 2022. doi:10.1016/S2213-8587(22)00212-1