TY - JOUR
T1 - The effect of discontinuing continuous glucose monitoring in adults with type 2 diabetes treated with basal insulin
AU - MOBILE Study Group
AU - Aleppo, Grazia
AU - Beck, Roy W.
AU - Bailey, Ryan
AU - Ruedy, Katrina J.
AU - Calhoun, Peter
AU - Peters, Anne L.
AU - Pop-Busui, Rodica
AU - Philis-Tsimikas, Athena
AU - Bao, Shichun
AU - Umpierrez, Guillermo
AU - Davis, Georgia
AU - Kruger, Davida
AU - Bhargava, Anuj
AU - Young, Laura
AU - Buse, John B.
AU - McGill, Janet B.
AU - Martens, Thomas
AU - Nguyen, Quang T.
AU - Orozco, Ian
AU - Biggs, William
AU - Lucas, K. Jean
AU - Polonsky, William H.
AU - Price, David
AU - Bergenstal, Richard M.
N1 - Funding Information:
Funding. Study funding and study devices were provided by Dexcom, Inc. Dexcom had no approval authority for the manuscript before submission, including no right to veto publication and no control on the decision regarding to which journal the manuscript was submitted. Duality of Interest. All authors received grant funding from Dexcom to their institution for the conduct of the submitted study. G.A. reports grants from AstraZeneca, Dex-com, Eli Lilly, Insulet, and Novo Nordisk and personal fees from Dexcom and Insulet. R.W.B. reports that his institution has received on his behalf grant funding and study supplies from Tandem Diabetes Care, Beta Bionics, and Dexcom; study supplies from Medtronic, Ascencia, and Roche; consulting fees and study supplies from Eli Lilly and Novo Nordisk; and consulting fees from Insulet, Bigfoot Biomedical, vTv Therapeutics, and Diasome. K.J.R. reports that her employer has received grant support from Beta Bionics and Tandem Diabetes Care. P.C. is a former Dexcom employee, and his current employer has received consulting payments on his behalf from vTv Therapeutics, Beta Bionics, Dexcom, and Diasome. A.L.P. reports serving on advisory boards for Abbott Diabetes Care, Eli Lilly, Medscape, Novo Nordisk, and Zealand; nonfinancial study supplies from Abbott Diabetes Care; and ownership of stock options for Omada Health and Teladoc. R.P.-B. reports serving on advisory boards for Averitas, Bayer, Boehringer Ingelheim, Nevro, and Novo Nordisk, and her institution received grants on her behalf from AstraZeneca. A.P.-T. reports that her employer has received funds on her behalf for research support, education support, consulting, or serving on the scientific advisory boards for Abbott Diabetes Care, Dexcom, Johnson & Johnson, Eli Lilly, Medscape, Medtronic, Novo Nordisk, Roche, Sanofi, and UnitedHealthCare. S.B. reports research funding paid to her institution, from Dexcom, Novo Nordisk, Mylan, AstraZeneca, and Bristol-Myers Squibb. G.U. reports research funding paid to his institution from Dexcom, Novo Nordisk, and AstraZeneca. G.D. reports funding paid to her institution from Insulet. D.K. reports grants and personal fees from Dexcom, consulting and research funds from Abbott Diabetes, consulting and speaking fees from Eli Lilly, consulting fees from Sanofi, speaker fees from Xeris Pharmaceuticals, and speaking, consulting, and research funding from Novo Nordisk. A.B. reports research grant–related funding from Abbott Diabetes, AbbVie, Amgen, Boehringer Ingelheim, Boston Therapeutics, Covance, Dexcom, Eli Lilly, Gan and Lee Pharmaceuticals, Insulet, Janssen, Kowa Pharmaceuticals, Madrigal Pharmaceuticals, Medtronic, Merck, Mylan, Novo Nordisk, Poxel, Quintiles, Sanofi, Senseonics, Tolerion, and Viking. L.Y. reports grant funds to her institution from Boehringer Ingelheim, Eli Lilly, Sanofi US, Tolerion, Novo Nordisk, Dexcom, and Bayer Health Care. J.B.B. reports that his employer has received funds on his behalf for consulting and travel from Adocia, AstraZeneca, Dance Bio-pharm, Dexcom, Eli Lilly, Fractyl, GI Dynamics, Intarcia Therapeutics, Lexicon, MannKind, Meta-vention, NovaTarg, Novo Nordisk, Orexigen, Pha-seBio, Sanofi, Senseonics, vTv Therapeutics, and Zafgen and research grants and travel support from AstraZeneca, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Lexicon, Medtronic, Nova-Targ, Novo Nordisk, Sanofi, Theracos, Tolerion, and vTv Therapeutics. J.B.M. reports advisory board fees from Bayer, Eli Lilly, Metavant, and Salix; consultancy fees from Boehringer Ingel-heim; and grants paid to her employer from Dexcom, Medtronic, and Novo Nordisk. T.M. reports funds paid to his nonprofit employer on his behalf for research support, speaking, or consulting from Abbott Diabetes Care, Dexcom, Insulet, Eli Lilly, Medtronic, Novo Nordisk, Med-scape, and Bigfoot Biomedical. Q.T.N.’s employer has received funds on his behalf for research support, consulting, or serving on the scientific advisory boards for AstraZeneca, Sanofi, Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Man-nKind, and Dexcom. W.B. reports research grant–related funding from Roche Diabetes Care, Novo Nordisk, Mylan, Gan and Lee Pharmaceuticals, and Dexcom. W.H.P. reports consultancy fees from Dexcom, Abbott Diabetes Care, Sanofi, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Pro-vention Bio, Insulet, Adocia, and Intuity and research support from Dexcom and Abbott Diabetes Care. D.P. is an employee of Dexcom and reports holding stock in the company. R.M.B. reports that his employer has received funds on his behalf for research support, consulting, or service on the scientific advisory boards for Abbott Diabetes Care, Ascenia, Bigfoot Biomedical, Dexcom, Hygieia, Johnson & Johnson, Eli Lilly, Medscape, Medtronic, Novo Nordisk, Onduo, Roche, Sanofi, and UnitedHealthCare. No other potential conflicts of interest relevant to this article were reported. Author Contributions. G.A. and R.W.B. wrote the first draft of the manuscript and all other authors contributed to the final version. R.B. and P.C. conducted the statistical analyses. D.P., an employee of Dexcom, was involved in the review of the manuscript and interpretation of the data before submission for publication. R.W.B. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. R.W.B. and K.J.R. provided study coordination and oversight. G.A., A.L.P., R.P.-B., A.P.-T., S.B., G.U., G.D., D.K., A.B., L.Y., J.B.B., J.B.M., T.M., Q.T.N., I.O., W.B., K.J.L., and R.M.B. served as site investigators responsible for the conduct of the protocol at their sites. W.H.P. provided guidance with respect to quality of life measures. D.P. served as medical monitor and sponsor representative. Prior Presentation. Parts of this study were included in an oral presentation at the 14th International Conference on Advanced Technologies & Treatments for Diabetes, Virtual, 2–5 June 2021.
Publisher Copyright:
© 2021 by the American Diabetes Association.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - OBJECTIVE To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin. RESEARCH DESIGN AND METHODS This multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM (n = 57) and the CGM group was randomly reassigned either to continue CGM (n = 53) or discontinue CGM with resumption of BGM for glucose monitoring (n = 53). RESULTS In the group that discontinued CGM, mean time in range (TIR) 70–180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months-12% [95% CI-21% to-3%], P = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI-11% to 12%], P = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was-6% (95% CI-16% to 4%, P = 0.20). CONCLUSIONS In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use.
AB - OBJECTIVE To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin. RESEARCH DESIGN AND METHODS This multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM (n = 57) and the CGM group was randomly reassigned either to continue CGM (n = 53) or discontinue CGM with resumption of BGM for glucose monitoring (n = 53). RESULTS In the group that discontinued CGM, mean time in range (TIR) 70–180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months-12% [95% CI-21% to-3%], P = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI-11% to 12%], P = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was-6% (95% CI-16% to 4%, P = 0.20). CONCLUSIONS In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use.
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U2 - 10.2337/dc21-1304
DO - 10.2337/dc21-1304
M3 - Article
C2 - 34588210
AN - SCOPUS:85120855275
SN - 1935-5548
VL - 44
SP - 2729
EP - 2737
JO - Diabetes Care
JF - Diabetes Care
IS - 12
ER -
