N. Sabelli, MR. Pasqua, N. Perz, D. Majdpour, M. Tsoukas and A. Haidar (2026). Transient Benign Ketosis Is Common in Type 1 Diabetes During Very-Low Carbohydrate States: Novel Data from Continuous Ketone Sensor. Diabetes technology & therapeutics, 28(7), 682-688. https://doi.org/10.1177/15209156251412812

PubMed 42381172

[Abstract]
OBJECTIVE: Continuous ketone sensors have the potential to reduce diabetic ketoacidosis in type 1 diabetes. We evaluated the accuracy of a novel ketone sensor and quantified physiological ketone metrics during ketogenic diets in type 1 diabetes.

RESEARCH DESIGN AND METHODS: Adult participants on automated insulin delivery wore SiBio continuous ketone sensors and underwent two 6-day ketogenic diets, in random order. The two diets were very-low carbohydrate (<50 g/day) and intermittent 12-h fasting. Between the two diets, participants were admitted for a 6- to 8-h insulin suspension experiment to assess sensor accuracy. Ketone sensor readings were compared with capillary levels by FreeStyle Libre 2 meter.

RESULTS: Sixteen participants completed the study (age 36.5 [17.0] years, HbA1c 7.0% [0.6], insulin dose 0.72 [0.26] units/kg) and provided 870 sensor-meter paired data points. The mean absolute difference (MAD) for ketone values <0.6 mmol/L was 0.1 (0.1) mmol/L and the relative MADs for ketone values ≥0.6 and ≥1.0 mmol/L were 24.2% (17.1) and 19.6% (13.3), respectively. During the ketogenic diets (155 days), there were 81 ketosis events (3.7 events/week) ≥0.6 mmol/L of more than 15 min, with a median duration of 60 (30-105) min/event. All ketosis events except one were asymptomatic. Glucose levels, basal insulin delivery, and time of the day were not related to ketosis events.

CONCLUSIONS: SiBio ketone sensor demonstrated preliminary accuracy and reveals that benign, transient ketosis are common in type 1 diabetes during very-low carbohydrate states. This has implications on the utility of continuous ketone sensors in clinical practice.

TRIAL REGISTRATION: Clinicaltrials.gov NCT06420518.