Advanced hybrid closed-loop system may improve glucose control in youth with high-risk type 1 diabetes

Benjamin Wheeler, MBChB, PhD

The results of a new study show that researchers say that advanced hybrid closed-loop therapy should be considered a first-line option for youth with high-risk type 1 diabetes, using multiple daily injections.

In a single-arm, two-center study of people with high-risk type 1 diabetes aged 13-25 years with an HbA1c of 8.5% or greater, the study results showed that the use of advanced hybrid gated therapy in the patient population was associated with a reduction of almost 3 percentage points in HbA1c at 3 months, with an increase of more than 30 percentage points for the time spent in the target range.

“This study describes the largest gains yet reported for youth with high-risk glycemia, with a mean improvement in HbA1c of 2.9 percentage points (31.5 mmol/mol). The mean TIR improved by 38.9 percentage points, which was mostly due to a 38.4 percentage point reduction in time spent above 250 mg/dL,” the researchers wrote.

As diabetes technology advances, so does the pool of patients who use these advances. At the forefront of diabetes technology are continuous glucose monitoring and insulin pump systems. Although advanced hybrid closed systems have been studied in youth with type 1 diabetes, the researchers pointed out that previous studies focused on patients aged 7-17 years and also excluded those with HbA1c above 12.4%. Led by Benjamin Wheeler, MBChB, PhD, associate professor and pediatric endocrinologist at the University of Otago, and a team of collaborators launched the current study, which was funded by a Lottery Research Grant, with the intention of investigating the utility of an advanced hybrid closed system in those with diabetes type 1 aged 13-25 years, no upper limit for HbA1c entry.

The primary study outcomes of interest were time in the 70-180 mg/dL range and change in HbA1c between baseline and the end of the study period. In the study, the advanced closed-loop hybrid system consisted of a Medtronic MiniMed 780G insulin pump and a Guardian 3 sensor with a Guardian Link 3 transmitter. The researchers adapted a 10-day protocol to start the study, with a structured 72-hour rapid onboarding being the key adaptation.

A total of 20 participants underwent enrollment between October 6, 2021 and February 1, 2022 and completed the 3-month intervention. This cohort had a mean age of 18.8 (13.3-25.7), 60% were female, mean HbA1c 10.5% (SD, 2.1), mean BMI 25.2 (SD, 5.9) kg /m2, mean duration of diabetes 9.7 (SD, 5.4) years, and mean total daily insulin dose was 71.1 (SD, 25.7) units.

On analysis, the results showed that mean HbA1c among the cohort decreased from 10.5% (SD, 2.1) at baseline to 7.6% (SD, 1.1) at 3 months (difference, 2.9 percentage points ). In addition, time spent in the target range of 70-180 mg/dL increased from 27.6% (SD, 13.2) at baseline to 66.5 (SD, 9.8) at 3 months (difference, 38.9 percentage points), with this improvement in time in range driven by a 38.4 percentage point reduction in time spent above 250 mg/dL. In their conclusion, the researchers highlighted a study participant with a baseline HbA1c of 17.6% and 0% time in target range who reduced HbA1c to 7.9% and improved time in target range to 60% at 3 months.

“For populations with less complex type 1 diabetes, closed-loop systems are now the gold standard of a therapeutic option. AHCL, combined with adequate training and clinical support, should now be considered a first-line therapeutic tool for those most likely to benefit, namely youth with high-risk glycemia,” the researchers concluded.

This study, “Impact of an advanced hybrid closed-loop on youth with high-risk type 1 diabetes using multiple daily injections,” was published in Diabetes care.

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