Abstract
BackgroundHypoglycemia is the main side effect of intensified insulin therapy in type 1 diabetes and recognized as a limitation in achieving glycemic targets. Patients with impaired awareness of hypoglycemia have a threefold to sixfold increased risk of severe hypoglycemia. Real-time continuous glucose monitoring may help patients with type 1 diabetes to achieve better glycemic control with less hypoglycemic episodes. Accordingly, one may hypothesize that particularly type 1 diabetes mellitus patients with impaired awareness of hypoglycemia will profit most from this technology with improvements in their quality of life. However, this has not yet been established. This trial aims to study the effect of real-time continuous glucose monitoring on glycemia and quality of life specifically in type 1 diabetes mellitus patients with established impaired awareness of hypoglycemia.Methods/designThis is a two-center, randomized, cross-over trial with a 12-week wash-out period in between intervention periods. A total of 52 type 1 diabetes mellitus patients with impaired awareness of hypoglycemia according to Gold et al. criteria will be randomized to receive real-time continuous glucose monitoring or blinded continuous glucose monitoring for 16 weeks. After a wash-out period, patients will cross over to the other intervention. The primary outcome measure is time spent in euglycemia. Secondary outcomes include (diabetes-specific) markers of quality of life and other glycemic variables.DiscussionIt remains unclear whether patients with type 1 diabetes and impaired awareness of hypoglycemia benefit from real-time continuous glucose monitoring in real-life. This study will provide insight into the potential benefits of real-time continuous glucose monitoring in this patient population.Trial registrationClinicaltrials.gov: NCT01787903.Electronic supplementary materialThe online version of this article (doi:10.1186/s12902-015-0040-3) contains supplementary material, which is available to authorized users.
Highlights
Hypoglycemia is the main side effect of intensified insulin therapy in type 1 diabetes and recognized as a limitation in achieving glycemic targets
It remains unclear whether patients with type 1 diabetes and impaired awareness of hypoglycemia benefit from real-time continuous glucose monitoring in real-life
We hypothesize that the use of RT-Continuous glucose monitoring (CGM), relative to a control intervention using masked CGM, will result in improvement of time spent in euglycemia and quality of life in Type 1 diabetes mellitus (T1DM) patients with impaired awareness of hypoglycemia (IAH)
Summary
It seems obvious that T1DM patients with IAH could potentially benefit from RT-CGM, the effect of conventional RT-CGM (without automated insulin suspension) has not yet been established in an ambulatory setting. RT-CGM was not superior over self-monitoring of blood glucose by finger prick During this trial, strict insulin titration protocols where used, which may not reflect real-life diabetes management. Ly et al showed that sensor-augmented insulin pump therapy with automated insulin suspension reduced the frequency of SH significantly in T1DM patients with IAH [83], this reduction lost significance when 2 outliers, whose rates of hypoglycemia were higher at baseline, were removed from analysis. It remains unclear whether T1DM patients with IAH benefit from conventional RTCGM in real-life.
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