DOI: 10.1177/29986702261475723 ISSN: 2998-6702

Changes in Hypoglycemic Event Characteristics During Use of a Bihormonal Fully Closed-Loop System for Type 1 Diabetes

Stennie Zoet, Thomas Urgert, Lyan B. Vlaskamp, Theodorus JP. Jansen, Bert-Jan F. van Beijnum, Gozewijn D. Laverman
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Objective:

To perform an in-depth analysis of changes in hypoglycemic event characteristics during treatment with a bihormonal fully closed-loop (FCL) system (Inreda AP; Inreda Diabetic, Goor, The Netherlands) compared with prior treatment.

Research Design and Methods:

One-year data from 25 individuals with type 1 diabetes using an FCL system as their regular treatment were analyzed. The average frequency, severity, duration, depth, and shape of hypoglycemic events (glucose < 3.9 mmol/L for ≥5 min) were calculated from continuous glucose monitoring data and compared with prior therapy.

Results:

Mean age was 50.0 (±11.1) years, and 52.0% were male. Prior treatment comprised conventional subcutaneous pumps with intermittent ( n = 12) or continuous ( n = 10) glucose sensors (one of which was a hybrid closed-loop) and multiple daily injections ( n = 3). Mean time in range was 78.6% (±6.4) with FCL treatment versus 58.0% (±16.1) with prior therapy ( P < 0.001). The mean area under the curve of a hypoglycemic event significantly decreased during FCL treatment (23.4 min·mmol/L [±12.2] to 7.7 min·mmol/L [IQR: 7.1–10.0], P < 0.001). Event duration and average event glucose also significantly reduced (duration was 44.1 [±14.2] versus 29.6 [±7.4] min [ P < 0.001], and average glucose level was 3.52 [±0.11] versus 3.63 [±0.04] mmol/L [ P < 0.001]). Overall time below range significantly decreased (2.9% [IQR: 1.1–4.6] to 1.5% [IQR: 0.7–1.8], P = 0.003), while hypoglycemic event frequency remained unchanged (0.9 [±0.6] versus 0.8 [±0.4] per day, P = 0.430).

Conclusions:

In a real-world setting, treatment with a bihormonal FCL system leads to long-term improvements in the severity, duration, depth, and shape of hypoglycemic events, accompanied by a reduction in mean glucose levels, thereby contributing to tighter glucose regulation compared with prior conventional therapy.

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