The DOI matches its Crossref record; 24 of the 25 references it cites were found in a registry or an index.
REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes
Open accessAbstract
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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]
In the citing paper
“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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Continuous glucose monitoring and intensive treatment of type 1 diabetes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0805017 · Cited by 1,559
Miller, K. M., Foster, N. C., Beck, R. W., Bergenstal, R. M., DuBose, S. N., DiMeglio, L. A., Maahs, D. M., & Tamborlane, W. V. (2015) · Diabetes Care · doi:10.2337/dc15-0078 · Cited by 1,254
Self-citationEffectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes
Bergenstal, R. M., Tamborlane, W. V., Ahmann, A., Buse, J. B., Dailey, G., Davis, S. N., Joyce, C., Peoples, T., Perkins, B. A., Welsh, J. B., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1002853 · Cited by 894
Clarke, W. L., Cox, D. J., Gonder-Frederick, L. A., Julian, D., Schlundt, D., & Polonsky, W. (1995) · Diabetes Care · doi:10.2337/diacare.18.4.517 · Cited by 651 · cited 2×
“Exclusion criteria included the occurrence of a severe hypoglycemic event resulting in seizure or loss of consciousness in the past 3 years or an event without seizure or loss of consciousness requiring the assistance of another individual in the past 12 months, significant hypoglycemia unawareness based on the Clarke…”
BackgroundInfluentialFear of hypoglycemia: quantification, validation, and utilization
Cox, D. J., Irvine, A., Gonder-Frederick, L., Nowacek, G., & Butterfield, J. (1987) · Diabetes Care · doi:10.2337/diacare.10.5.617 · Cited by 579 · cited 1×
“The following questionnaires were completed at baseline and 26weeks: the Diabetes Technology Questionnaire, which consists of 30 questions about diabetes self-treatment practices and the impact of living with diabetes on the individual (20), and the Hypoglycemia Fear Survey, which consists of 23 questions about the ef…”
MethodPickup, J. C., Freeman, S. C., & Sutton, A. J. (2011) · BMJ · doi:10.1136/bmj.d3805 · Cited by 541
Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes
Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011) · Diabetes Care · doi:10.2337/dc10-1989 · Cited by 496
Yeh, H.-C., Brown, T. T., Maruthur, N., Ranasinghe, P., Berger, Z., Suh, Y. D., Wilson, L. M., Haberl, E. B., Brick, J., Bass, E. B., et al. (2012) · Annals of Internal Medicine · doi:10.7326/0003-4819-157-5-201209040-00508 · Cited by 493
The effect of continuous glucose monitoring in well-controlled type 1 diabetes
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2009) · Diabetes Care · doi:10.2337/dc09-0108 · Cited by 399
Peters, A. L., Ahmann, A. J., Battelino, T., Evert, A., Hirsch, I. B., Murad, M. H., Winter, W. E., & Wolpert, H. (2016) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-2534 · Cited by 250
Self-citationAssessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring
Kovatchev, B. P., Patek, S. D., Ortiz, E. A., & Breton, M. D. (2015) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2014.0272 · Cited by 234
Fonseca, V. A., Grunberger, G., Anhalt, H., Bailey, T. S., Blevins, T., Garg, S. K., Handelsman, Y., Hirsch, I. B., Orzeck, E. A., Roberts, V. L., et al. (2016) · Endocrine Practice · doi:10.4158/ep161392.cs · Cited by 195
Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm
Bailey, T. S., Chang, A., & Christiansen, M. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296814559746 · Cited by 168
Tamborlane, W. V., Bode, B. W., Buckingham, B. A., Chase, H. P., Clemons, R. D., Fox, L. A., Gilliam, L. K., Hirsch, I. B., Huang, E. S., Kollman, C., et al. (2008) · Cited by 167
Self-citationChristiansen, M. P., Bailey, T. S., Watkins, E., Liljenquist, D. R., Price, D. A., Nakamura, K., Boock, R. J., & Peyser, T. A. (2013) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2013.0077 · Cited by 140 · cited 1×
“Current Medtronic CGM user 20 (13) 10 (13)”
BackgroundA Comparative Effectiveness Analysis of Three Continuous Glucose Monitors
Damiano, E. R., McKeon, K., El-Khatib, F. H., Zheng, H., Nathan, D. M., & Russell, S. J. (2014) · Journal of Diabetes Science and Technology · doi:10.1177/1932296814532203 · Cited by 139
Gandhi, G. Y., Kovalaske, M. A., Kudva, Y. C., Walsh, K., Elamin, M. B., Beers, M. C., Coyle, C., Goalen, M. J., Murad, M. S., Erwin, P. J., et al. (2011) · Journal of Diabetes Science and Technology · doi:10.1177/193229681100500419 · Cited by 136
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2010.0015 · Cited by 103
Matuleviciene, V., Joseph, J. I., Andelin, M., Hirsch, I. B., Attvall, S., Pivodic, A., Dahlqvist, S., Klonoff, D. C., Haraldsson, B. S., & Lind, M. (2014) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2014.0238 · Cited by 83
Self-citationZisser, H., Bailey, T. S., Schwartz, S. L., Ratner, R. E., & Wise, J. K. (2009) · Journal of Diabetes Science and Technology · doi:10.1177/193229680900300519 · Cited by 77
Continuous glucose monitoring in patients with type 1 diabetes using insulin injections
Foster, N. C., Miller, K. M., Tamborlane, W. V., Bergenstal, R. M., & Beck, R. W. (2016) · Diabetes Care · doi:10.2337/dc16-0207 · Cited by 76
Self-citationPettus, J., Price, D. A., & Edelman, S. V. (2015) · Endocrine Practice · doi:10.4158/ep14520.or · Cited by 62 · cited 1×
“In another survey of 222 CGM users, 50% of respondents indicated that during the night, they would treat a CGM low-glucose alert without a confirmatory fingerstick glucose, and 34% would dose insulin for hyperglycemia without a confirmatory BGM measurement (18).”
BackgroundHypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study
Weiss, R., Garg, S. K., Bode, B. W., Bailey, T. S., Ahmann, A., Schultz, K. A., Welsh, J. B., Shin, J., & for the ASPIRE In-Home Study Group (2015) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2014.0306 · Cited by 54
Self-citationSenior, P. A., Bellin, M. D., Alejandro, R., Yankey, J. W., Clarke, W. R., Qidwai, J. C., Schwieger, T., Eggerman, T. L., Robien, M. A., & Rickels, M. R. (2015) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2014.0289 · Cited by 33
Self-citation
Cited by
Sorted by citations
Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0028 · Cited by 4,237
“Numerous studies have demonstrated significant clinical benefits of CGM use in people with diabetes regardless of insulin delivery metho d (1-15).”
BackgroundSelf-citationContinuous glucose monitoring and metrics for clinical trials: an international consensus statement
Battelino, T., Alexander, C. M., Amiel, S. A., Arreaza-Rubin, G., Beck, R. W., Bergenstal, R. M., Buckingham, B. A., Carroll, J., Ceriello, A., Chow, E., et al. (2023) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00319-9 · Cited by 831
Self-citation6. Glycemic Targets: Standards of Medical Care in Diabetes—2018
American Diabetes Association (2017) · Diabetes Care · doi:10.2337/dc18-s006 · Cited by 790
Glucose management indicator (GMI): a new term for estimating A1C from continuous glucose monitoring
Bergenstal, R. M., Beck, R. W., Close, K. L., Grunberger, G., Sacks, D. B., Kowalski, A., Brown, A. S., Heinemann, L., Aleppo, G., Ryan, D. B., et al. (2018) · Diabetes Care · doi:10.2337/dc18-1581 · Cited by 684
Self-citationBlonde, L., Umpierrez, G. E., Reddy, S. S., McGill, J. B., Berga, S. L., Bush, M., Chandrasekaran, S., DeFronzo, R. A., Einhorn, D., Galindo, R. J., et al. (2022) · Endocrine Practice · doi:10.1016/j.eprac.2022.08.002 · Cited by 507
Self-citation
Metadata
- 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
- 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
- FWCI
- 25.06
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
