Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes
- Tadej Battelino, MD, PHD1⇓,
- Moshe Phillip, MD2,
- Natasa Bratina, MD, PHD1,
- Revital Nimri, MD2,
- Per Oskarsson, MD, PHD3 and
- Jan Bolinder, MD, PHD3
- 1Department of Pediatric Endocrinology, Diabetes and Metabolism, UMC-University Children’s Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
- 2The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center, Petah Tikva and Sackler Faculty of Medicine, Tel-Aviv University, Israel
- 3Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden
- ↵Corresponding author: Tadej Battelino, .
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 A1c (HbA1c) <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). HbA1c 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 HbA1c in children and adults with type 1 diabetes.
Clinical trial reg. no. NCT00843609, clinicaltrials.gov.
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc10-1989/-/DC1.
- Received October 20, 2010.
- Accepted January 13, 2011.
- © 2011 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.