Evaluation of a novel continuous glucose monitoring guided system for adjustment of insulin dosing - PumpTune: a randomized controlled trial.

OBJECTIVE: Retrospective continuous glucose monitoring (CGM) can guide insulin pump adjustments, however, interpretation of data and recommending new pump settings is complex and subjective. We aimed to compare the safety and glycaemic profiles of children after their diabetologist or a novel algorithm (PumpTune) adjusted their insulin pump settings. RESEARCH DESIGN AND METHODS: In a randomized cross-over trial of 22 patients aged 6-14 yr with type 1 diabetes with mean Hba1c 7.4% (57 mmol/mol) using CSII, CGM was used over two periods each of 6.5 d to assess percentage time glucose remained within, above and below 3.9-10.0 mmol/L. Before the start of one period pump settings were adjusted by the patient's diabetologist, and before the other insulin pump settings were adjusted by PumpTune.
RESULTS: A total of 63.4% of the sensor glucose levels were within target range with PumpTune settings and 57.4% were within range with the clinician settings (p = 0.016). The time spent above target range with PumpTune was 26.9% and with clinician settings was 33.5% (p = 0.021). The time spent below target range with PumpTune was 9.7% and with clinician settings was 9.2% (p = 0.77). The mean number of times when a sensor glucose level <2.75 mmol/L was recorded with PumpTune settings was 2.9 compared with 3.7 with clinician settings (p = 0.39). There were no serious adverse outcomes and no difference in parent-assessed satisfaction.
CONCLUSIONS: Automated insulin pump adjustment with PumpTune is feasible and warrants testing in a larger more varied population over a longer time. In this well-controlled group of children, PumpTune achieved a more favorable glucose profile.

RCT Entities:   Population Interventions Outcomes