The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial
Diabetologia - Clinical and Experimental Diabetes and Metabolism, 09/13/2012
Clinical Article
Battelino T et al. – Continuous glucose monitoring was associated with decreased HbA1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self–adjustments of insulin therapy may have contributed to these effects.
Methods
- Children and adults (n = 153) on CSII with HbA1c 7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months.
- After 4 months’ washout, participants crossed over to the other arm for 6 months.
- Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres.
- The primary outcome was the difference in HbA1c levels between arms after 6 months.
Results
- Seventy–seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis.
- The mean difference in HbA1c was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI –0.32%, –0.55% [–3.50, –6.01 mmol/mol]; p < 0.001).
- Following cessation of glucose sensing, HbA1c reverted to baseline levels.
- Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009).
- The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions.
- Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40).