Table 3

Comparison of glucose control and insulin delivery within feasibility and pilot study

Intervention study control
Intervention study real-time CGM
Sensor glucose levels
 Per cent time in range
  2.6–10 mmol/L*78.4 (58.9–94.2)59.0 (43.8–97.5)76.5 (63.8–97.3)
  4.00 to 8.0 mmol/L45.7 (34.6–65.7)33.0 (22.5–81.0)37.0 (30.0– 51.2)
  >10.0 mmol/L21.6 (5.8–40.9)40.0 (3.0–57.3)23.5 (2.8–35.3)
  <2.6 mmol/L0.0 (0.0–0.0)0.0 (0.0–0.0)0.0 (0.0–0.0)
  Mean SG (mmol/L)8.3 (7.4–9.4)9.5 (6.5–11.5)8.5 (6.7–9.4)
  SD of SG (mmol/L)2.39 (1.77–3.67)2.50 (1.46–4.32)1.96 (1.54–3.87)
 Hypoglycaemia (sensor data)†
  No of babies with > 1 episode of hypoglycaemia221
  No of episodes of hypoglycaemia221
  Length of episodes (mins)40–70325–410205
 Blood glucose (<2.6 mmol/L)
  No of episodes of hypoglycaemia†3†21
 Insulin infused (U/kg/day)0.02 (0.00–0.06)0.03 (0.01–0.06)
 Number of blood glucose levels per day5.36 (3.43–5.82)5.14 (4.29–5.43)
  • Greater time in target 2.6–10 mmol/L in both study groups using real-time CGM (intervention arm of the pilot study and accuracy study). Lower prevalence of hyperglycaemia in those using real-time CGM and prolonged periods of hypoglycaemia in the control arm of the pilot study. No difference in the frequency of BG monitoring or insulin infused between the arms of the pilot study. Data are presented as median (IQR). 

  • *Primary endpoint.

  • Hypoglycaemic episode defined as any BG <2.6 mmol/L or SG <2.6 mmol/L>30 min. There was one episode where BG<2.6 mmol/L but the SG fell to a nadir of 2.7 mmol/L.

  • BG, blood glucose; CGM, continuous glucose monitoring; SG, sensor glucose.