Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes

Tadej Battelino, Moshe Phillip, Natasa Bratina, Revital Nimri, Per Oskarsson, Jan Bolinder, Tadej Battelino, Moshe Phillip, Natasa Bratina, Revital Nimri, Per Oskarsson, Jan Bolinder

Abstract

Objective: To assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes.

Research design and methods: In this randomized, controlled, multicenter study, 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A(1c) (HbA(1c)) <7.5% were randomly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearing a masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring. The primary outcome was the time spent in hypoglycemia (interstitial glucose concentration <63 mg/dL) over a period of 26 weeks. Analysis was by intention to treat for all randomized patients.

Results: The time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group (mean ± SD 0.48 ± 0.57 and 0.97 ± 1.55 h/day, respectively; ratio of means 0.49; 95% CI 0.26-0.76; P = 0.03). HbA(1c) at 26 weeks was lower in the continuous monitoring group than in the control group (difference -0.27%; 95% CI -0.47 to -0.07; P = 0.008). Time spent in 70 to 180 mg/dL normoglycemia was significantly longer in the continuous glucose monitoring group compared with the control group (mean hours per day, 17.6 vs. 16.0, P = 0.009).

Conclusions: Continuous glucose monitoring was associated with reduced time spent in hypoglycemia and a concomitant decrease in HbA(1c) in children and adults with type 1 diabetes.

Figures

Figure 1
Figure 1
Time spent below 63 mg/dL by month. Mean values ± SEs for hours per day spent

Figure 2

Glycated HbA 1c at 2,…

Figure 2

Glycated HbA 1c at 2, 4, and 6 months and cumulative distribution of…

Figure 2
Glycated HbA1c at 2, 4, and 6 months and cumulative distribution of HbA1c levels at 6 months. Mean values are ± SEs for HbA1c (in %) over the 6-month study period in all patients. The means were adjusted for clinical center and adult or pediatric patient. An asterisk denotes statistical significance for comparison between the continuous monitoring and control groups with P < 0.05 (A); cumulative distribution of HbA1c levels at 6 months among all patients is shown. The vertical line represents the American Diabetes Association target of 7.0% (B). ●, continuous monitoring group; ▲, control group.
Figure 2
Figure 2
Glycated HbA1c at 2, 4, and 6 months and cumulative distribution of HbA1c levels at 6 months. Mean values are ± SEs for HbA1c (in %) over the 6-month study period in all patients. The means were adjusted for clinical center and adult or pediatric patient. An asterisk denotes statistical significance for comparison between the continuous monitoring and control groups with P < 0.05 (A); cumulative distribution of HbA1c levels at 6 months among all patients is shown. The vertical line represents the American Diabetes Association target of 7.0% (B). ●, continuous monitoring group; ▲, control group.

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