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REPLACE-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in adults with well-controlled type 1 diabetes

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Aleppo, Grazia, Ruedy, Katrina J., Riddlesworth, Tonya D., Kruger, Davida F., Peters, Anne L., Hirsch, Irl, Bergenstal, Richard M., Toschi, Elena +12 more·2017·Diabetes Care
DOI 10.2337/dc16-2482PMC PMC5864100
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Abstract

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 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA1c ≤9.0% (≤75 mmol/mL) (mean 7.0 ± 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: CGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+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.

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  • Numerous studies have demonstrated significant clinical benefits of CGM use in people with diabetes regardless of insulin delivery method.

    “Numerous studies have demonstrated significant clinical benefits of CGM use in people with diabetes regardless of insulin delivery method (1-15).”

    From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [2]

    The Introduction reports that several randomized trials found CGM benefits, including reduced HbA1c and hypoglycemia, particularly in adults with type 1 diabetes. But the Conclusions say this trial included only insulin-pump users; extending its results to people using injections is described as reasonable, not demonstrated. The paper therefore does not establish benefits regardless of insulin delivery method or across all people with diabetes. (LLM, conf=0.86)

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  • The increasing accuracy of CGM devices and at least one RCT comparing nonadjunctive to adjunctive use has led the FDA to approve most current CGM devices for nonadjunctive use in the U.S.

    “However, the increasing accuracy of the devices and at least one RCT comparing nonadjunctive to adjunctive use (191) has led the FDA to approve most current CGM devices for nonadjunctive use in the U.S.”

    From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [191]

  • Multiple studies report a strong linear relationship between percent time in range (70-180 mg/dL) and A1C in people with T1D and T2D.

    “Based on the results of multiple studies reporting a strong linear relationship between percent time in range (TIR) (70–180 mg/dL) and A1C in persons with T1D and T2D”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [154]

    The Results (Glycemic Control and Other Outcomes; page unavailable) report time in range and HbA1c as separate outcomes in adults with type 1 diabetes, but do not report a strong linear relationship between them. Searches for a TIR–HbA1c relationship and correlation found no such analysis in our copy; the study does not include people with type 2 diabetes. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • CGM systems are generally nonadjunctive, meaning they do not require BGM confirmation for treatment decisions like insulin dosing or treating hypoglycemia, except in certain clinical situations.

    “CGM systems are generally nonadjunctive, meaning they do not require BGM confirmation for treatment decisions like insulin dosing or treating hypoglycemia, except in certain clinical situations (see BLOOD GLUCOSE MONITORING, above) (44-46).”

    From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [44]

  • Some non-iCGM-approved CGM devices require additional user verification of blood glucose levels for making treatment decisions, termed adjunctive.

    “Some of these non-iCGM-approved CGM devices require additional user verification of blood glucose levels to be performed for making treatment decisions, termed adjunctive.”

    From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [12]

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Authors
Aleppo, G., Ruedy, K. J., Riddlesworth, T. D., Kruger, D. F., Peters, A. L., Hirsch, I., Bergenstal, R. M., Toschi, E., Ahmann, A. J., Shah, V. N., Rickels, M. R., Bode, B. W., Philis-Tsimikas, A., Pop-Busui, R., Rodriguez, H., Eyth, E., Bhargava, A., Kollman, C., Beck, R. W., & for the REPLACE-BG Study Group
Affiliations
  • Northwestern University (US)
  • Jaeb Center for Health Research (US)
  • Henry Ford Health (US)
  • University of Southern California (US)
  • University of Washington (US)
  • Park Nicollet Health Services (US)
  • Joslin Diabetes Center (US)
  • Oregon Health & Science University (US)
  • Barbara Davis Center for Childhood Diabetes, Aurora, CO
  • University of Pennsylvania (US)
  • Atlanta Diabetes Associates (US)
  • Scripps Whittier Diabetes Institute, La Jolla, CA
  • University of Michigan, Ann Arbor, MI
  • University of South Florida (US)
  • Iowa Diabetes and Endocrinology Research Center (US)
Corresponding author
Riddlesworth, Tonya D.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2017-02-16
Volume
40
Issue
4
Pages
538-545
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc16-2482
PMC
PMC5864100
OpenAlex
W2589083807
Semantic Scholar
90d778291a6be773ec0116f890b79ecf1b9a36bb
Cited by
329
References
25
Citations by year
2026: 30 · 2025: 27 · 2024: 38 · 2023: 43 · 2022: 37 · 2021: 36 · 2020: 39 · 2019: 27 · 2018: 31 · 2017: 19 · 2016: 1
FWCI
25.06
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/content/license (vor, 33 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
Leona M. and Harry B. Helmsley Charitable Trust
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
continuous glucose monitoring, type 1 diabetes, blood glucose monitoring, time in range, insulin pump therapy, hypoglycemia, glycemic control, non-inferiority, adults
MeSH terms
Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Insulin Infusion Systems, Male, Middle Aged, Socioeconomic Factors, Blood Glucose Self-Monitoring, Young Adult

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