Real-time continuous glucose monitoring improves time spent in euglycaemia and prevents severe hypoglycaemia in type 1 diabetes mellitus patients with impaired awareness of hypoglycaemia

Prof. C.A.J van Beers presented results about continuous glucose monitoring at the EASD meeting (12nd to 16th September 2016) in Munich

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Background and aims: Real-time continuous glucose monitoring (RT-CGM) reduces HbA1c without increasing hypoglycaemia. Type 1 diabetes mellitus (T1DM) patients with impaired awareness of hypoglycaemia (IAH) have a threefold to sixfold increased risk of severe hypoglycaemia. Whether RT- CGM prevents hypoglycaemia in this high risk (IAH) population has yet to be established.

Materials and methods: Fifty-two adult T1DM patients with IAH as confirmed by a Gold score ≥4 were enrolled in a two-centre, randomised, cross-over trial with a 12-week wash-out period in between 16- week intervention periods comparing RT-CGM (without low-glucose suspend) with self-monitoring of blood glucose (SMBG). During SMBG, participants wore a blinded CGM continuously. CGM data were analysed on an intention-to-treat basis with time spent in euglycaemia [4-10 mmol/L] as primary endpoint. Severe hypoglycaemia (requiring third party assistance) was a secondary endpoint. Mixed model analysis was used to analyse time spent in euglycaemia. The Wilcoxon matched-pair signed-rank test was used to analyse the incidence rates of severe hypoglycaemic events. The proportion of patients experiencing at least one severe hypoglycaemic event was analysed with a generalized estimating equation model.

Results: Twenty-eight (53.8%) of enrolled patients were male, HbA1c was 7.5% ±0.8%, age 48.6 ±11.6 years, Gold score 5.4 ±0.7 and 23 (44.2%) patients were treated with continuous subcutaneous insulin infusion (CSII). Time spent in euglycaemia was significantly higher during RT-CGM: 65.0% vs. 55.4% (difference 9.6%, 95%CI 8.0-11.2, p<0.0001). In addition, both time spent ≤3.9 mmol/L (6.8% vs. 11.4%, difference 4.7%, 95%CI 3.4-5.9, p<0.0001) and time spent >10 mmol/L (28.2% vs. 33.2%, difference 5.0%, 95%CI 3.1-6.9, p<0.0001) were lower during RT-CGM. Also, less time was spent ≤3.9 mmol/L at night-time (0000-0600h) during RT-CGM (7.6% vs. 13.3%, difference 5.7%, 95%CI 3.2-8.2, p<0.0001). During RT-CGM, the number of severe hypoglycaemic events was lower (14 events vs. 34 events, p=0.03) and also the proportion of patients experiencing at least one severe hypoglycaemic event was lower (21% vs 38%, OR 0.48, 95%CI 0.22-1.04, p=0.06), with no interaction for treatment modality (CSII vs. multiple daily injection), p=0.4. HbA1c at the end of each period was similar (7.3% and 7.3%, p=0.8).

Conclusion: Real-time continuous glucose monitoring diminished severe hypoglycaemia in T1DM patients with IAH. Moreover, RT-CGM improved glycaemic control by decreasing both time spent in hypoglycaemia and time spent in hyperglycaemia. These data support the use of RT-CGM in this high risk population.

Clinical Trial Registration Number: NCT01787903
Supported by: Unrestricted grant from Eli Lilly and Sanofi
Disclosure: C.A.J. van Beers: Grants; The research leading to these results has received unrestricted grants from Ely Lilly and Sanofi.

Source EASD 2016

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