Over 150 patients were recruited for the study, including paediatric and adult patients. They were randomised to a continuous glucose monitoring Sensor On or Sensor Off group for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. HbA1c was the lab test used to control how well patients are controlling their diabetes. It shows the average level of blood glucose over the previous 3 months. The primary outcome of the study was the difference in HbA1c levels between arms after 6 months.
The results indicated a mean difference in HbA1c of –0.43% (–4.74 mmol/mol) in favour of the Sensor On group. While the Sensor was On, less time was spent with sensor glucose
In conclusion, in both paediatric and adult participants with type 1 diabetes using insulin pump therapy alone, the addition of continuous glucose monitoring resulted in an improvement in HbA1c with a decrease in time spent in hypoglycaemia. More frequent self-adjustments of insulin therapy with sensor-augmented insulin pump therapy may have contributed to these effects. The removal of continuous glucose monitoring resulted in a loss of metabolic benefit.