Transient Benign Ketosis Is Common in Type 1 Diabetes During Very-Low Carbohydrate States: Novel Data from Continuous Ketone Sensor.

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.