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

Click on the image to view the presentation

capture-decran-2016-09-18-a-17-27-10

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

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: