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Nocturnal continuous glucose monitoring: accuracy and reliability of hypoglycemia detection in patients with type 1 diabetes at high risk of severe hypoglycemia.

Abstract：

BACKGROUND:A reliable method to detect biochemical nocturnal hypoglycemia is highly needed, especially in patients with recurrent severe hypoglycemia. We evaluated reliability of nocturnal continuous glucose monitoring (CGM) in patients with type 1 diabetes at high risk of severe hypoglycemia. PATIENTS AND METHODS:Seventy-two type 1 diabetes patients with recurrent severe hypoglycemia (two or more events within the last year) participated for 4 nights in blinded CGM recordings (Guardian(®) REAL-Time CGMS and Sof-Sensor(®); Medtronic MiniMed, Northridge, CA). Blood was drawn hourly from 23:00 to 07:00 h for plasma glucose (PG) measurements (gold standard). RESULTS:Valid data were obtained in 217 nights. The sensitivity of CGM was 65% (95% confidence interval, 53-77%) below 4 mmol/L, 40% (24-56%) below 3 mmol/L, and 17% (0-47%) below 2.2 mmol/L. PG and CGM readings correlated in the total measurement range (Spearman's ρ=0.82; P<0.001). In the normo- and hyperglycemic ranges CGM underestimated PG by 1.1 mmol/L (0.9-1.2 mmol/L) (P<0.001); in contrast, in the hypoglycemic range (PG<4 mmol/L) CGM overestimated PG levels by 1.0 mmol/L (P<0.001). The mean absolute relative differences in the hypo- (≤3.9 mmol/L), normo- (4-9.9 mmol/L), and hyperglycemic (≥10 mmol/L) ranges were 45% (37-53%), 23% (22-25%), and 20% (19-21%), respectively. Continuous glucose error grid analysis indicated a clinical accuracy of 56%, 99%, and 93% in the hypo-, normo-, and hyperglycemic ranges, respectively. CONCLUSIONS:The accuracy in the hypoglycemic range of nocturnal CGM data using Sof-Sensor is suboptimal in type 1 diabetes patients at high risk of severe hypoglycemia. To ensure clinical useful sensitivity in detection of nocturnal hypoglycemic episodes, an alarm threshold should not be lower than 4 mmol/L.

journal_name

Diabetes Technol Ther

journal_title

Diabetes technology & therapeutics

authors

Bay C,Kristensen PL,Pedersen-Bjergaard U,Tarnow L,Thorsteinsson B

doi

10.1089/dia.2013.0004

subject

Has Abstract

pub_date

2013-05-01 00:00:00

pages

371-7

issue

eissn

1520-9156

issn

1557-8593

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Nocturnal continuous glucose monitoring: accuracy and reliability of hypoglycemia detection in patients with type 1 diabetes at high risk of severe hypoglycemia.