REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes

被引：224

作者：

Aleppo, Grazia ^{[1
]}

Ruedy, Katrina J. ^{[2
]}

Riddlesworth, Tonya D. ^{[2
]}

Kruger, Davida F. ^{[3
]}

Peters, Anne L. ^{[4
]}

Hirsch, Irl ^{[5
]}

Bergenstal, Richard M. ^{[6
]}

Toschi, Elena ^{[7
]}

Ahmann, Andrew J. ^{[8
]}

Shah, Viral N. ^{[9
]}

Rickels, Michael R. ^{[10
]}

Bode, Bruce W. ^{[11
]}

Philis-Tsimikas, Athena ^{[12
]}

Pop-Busui, Rodica ^{[13
]}

Rodriguez, Henry ^{[14
]}

Eyth, Emily ^{[14
]}

Bhargava, Anuj ^{[15
]}

Kollman, Craig ^{[2
]}

Beck, Roy W. ^{[2
]}

机构：

[1] Northwestern Univ, Chicago, IL USA

[2] Jaeb Ctr Hlth Res, Tampa, FL USA

[3] Henry Ford Hlth Syst, Detroit, MI USA

[4] Univ Southern Calif, Keck Sch Med, Los Angeles, CA USA

[5] Univ Washington, Sch Med, Seattle, WA USA

[6] Pk Nicollet Int Diabet Ctr, Minneapolis, MN USA

[7] Joslin Diabet Ctr, Boston, MA USA

[8] Oregon Hlth & Sci Univ, Harold Schnitzer Diabet Hlth Ctr, Portland, OR USA

[9] Barbara Davis Ctr Childhood Diabet, Aurora, CO USA

[10] Univ Penn, Perelman Sch Med, Philadelphia, PA USA

[11] Atlanta Diabet Associates, Atlanta, GA USA

[12] Scripps Whittier Diabet Inst, La Jolla, CA USA

[13] Univ Michigan, Ann Arbor, MI USA

[14] Univ South, Tampa, FL USA

[15] Iowa Diabet & Endocrinol Res Ctr, Des Moines, IA USA

来源：

DIABETES CARE | 2017年 / 40卷 / 04期

关键词：

HYPOGLYCEMIA; ACCURACY; SYSTEM;

D O I：

10.2337/dc16-2482

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE To determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults with well-controlled type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS A randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were >= 18 years of age (mean 44 6 14 years), had T1D for >= 1 year (mean duration 24 6 12 years), used an insulin pump, and had an HbA(1c) <= 9.0% (<= 75 mmol/mL) (mean 7.0 +/- 6 0.7% [53 +/- 7.7 mmol/mol]); prestudy, 47% were CGM users. Participants were randomly assigned 2: 1 to the CGM-only (n = 149) or CGM+BGM (n = 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%. RESULTS CGMuse averaged 6.7 +/- 0.5 and 6.8 +/- 0.4 days/week in the CGM-only andCGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 +/- 0.9 and 5.4 +/- 1.4 in the two groups, respectively (P < 0.001). Mean time in 70-180 mg/dL was 63 +/- 13% at both baseline and 26 weeks in the CGM-only group and 65 +/- 13% and 65 +/- 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group. CONCLUSIONS Use of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia.

引用

页码：538 / 545

页数：8

共 23 条

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