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Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial
Open accessAbstract
Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices. Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications. Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59). Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months. Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group. Conclusions and Relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03566693.
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“Benefits of CGM in this population include reductions in A1C, fewer severe hypoglycemia events in children and adults, increased TIR, as well as significant reductions in hospitalizations for severe hypoglycemia and DKA.156,162–168”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [167]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Continuous glucose monitoring for adults with type 2 diabetes (both those using and not using insulin)24,25 also achieves improved glycated haemoglobin concentrations without impacting the rate of hypoglycaemia.”
From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [24]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“Randomized controlled trials of the use of rt-CGM, compared with standard blood glucose monitoring, in adults with type 2 diabetes have generally shown reductions in HbA 1c with no significant change in time in hypoglycemia (169-172).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [172]
Experimental — accuracy not yet measuredIn the citing paper
“RCT data on rtCGM use in individuals with type 2 diabetes on MDI (59), mixed therapies (10, 60), and basal insulin (61,62) have consistently shown reductions in A1C levels and increases in TIR (70-180 mg/dL [3.9-10 mmol/L]) but not a reduction in rates of hypoglycemia (63).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [61]
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“17 The base case values for parameters representing QoL benefits associated with the rt-CGM intervention (ie, the combined 0.05536 utility value comprising avoidance of fingerstick testing [AFS] and FoH) were also altered.”
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“32 However, our patient characteristics were different: 50% of the MOBILE’s participants had commercial insurance and only 29% were Latino.”
InfluentialNishimura, R., Okada, Y., Kuroda, A., Suzuki, J., Hirota, Y., Matsuhisa, M., Ishiguro, M., Ohno, T., Suganuma, Y., Tanaka, K., et al. (2025) · Diabetology International · doi:10.1007/s13340-025-00820-2 · Cited by 7
“Furthermore, the MOBILE study reported a TIR of 59% and a TBR of 0.2% following real-time CGM in individuals with type 2 diabetes receiving insulin therapy [36].”
InfluentialHayek, A. A., Klonoff, D. C., Zahrani, W. M. A., Saeed, A. H. A., & Dawish, M. A. A. (2025) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2025.112458 · Cited by 8
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BackgroundInfluentialAmino Acid Nanofibers Improve Glycemia and Confer Cognitive Therapeutic Efficacy to Bound Insulin
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“…of real-time continuous glucose monitoring use on HbA1c (adjusted difference - 0.4% compared to BGM) and time in range (adjusted difference 15% comparedtoBGM)in175individualswith type 2 diabetes treated with basal insulin with or without noninsulin glucose-lowering medication over 8 months (53).”
InfluentialDiabetestechnologie (Update 2023)
Schütz-Fuhrmann, I., Rami-Merhar, B. M., Fröhlich-Reiterer, E. E., Hofer, S. E., Tauschmann, M., Mader, J. K., Resl, M., Kautzky‐Willer, A., Winhofer-Stöckl, Y., Laimer, M., et al. (2023) · Wiener klinische Wochenschrift · doi:10.1007/s00508-023-02165-9 · Cited by 5
“In einer RCT konnte eine signifikante HbA1c-Reduktion bei Menschen mit schlecht kontrolliertem Diabetes mellitus Typ 2 unter Einsatz von rtCGM gezeigt werden [36].”
BackgroundCurrent Obstacles (With Solutions) in Type 2 Diabetes Management, Alongside Future Directions
Belančić, A., Majanović, S. K., & Rahelić, D. (2023) · Diabetology · doi:10.3390/diabetology4030031 · Cited by 5
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“Initially developed and applied in type 1 diabetes mellitus (T1DM) [2–5], CGM has since demonstrated significant value in the care of patients with T2DM as well [6–9].”
InfluentialInequity in Continuous Glucose Monitor (CGM) Prescribing Behaviors in Primary Care
Milosavljevic, J., Schechter, C. B., Fazzari, M. J., Mathias, P., Mathew, J. T., & Agarwal, S. (2026) · Journal of General Internal Medicine · doi:10.1007/s11606-025-09923-7 · Cited by 4
“3,26,27 Partnership with specialty care may lower barriers to CGM use in primary care by bolstering clinicians’ confidence and familiarity with device initiation.”
Clinical Impact of Continuous Glucose Monitoring in Noninsulin Treated Type 2 Diabetes: A Review
Aleppo, G., Carlson, A. L., McGill, J. B., Alshannaq, H. A., Galindo, R. J., Kruger, D. F., Levy, C. J., Matuoka, J. Y., Ilham, S., Umpierrez, G. E., et al. (2026) · Diabetes Technology & Therapeutics · doi:10.1177/15209156251414980 · Cited by 5
Self-citationLind, N., Christensen, M. B., Hansen, D. L., Willaing, I., & Nørgaard, K. (2024) · Diabetic Medicine · doi:10.1111/dme.15321 · Cited by 4
Philis‐Tsimikas, A., Fortmann, A. L., Clark, T. L., Bagsic, S. R. S., Farcas, E., Roesch, S. C., SCHULTZ, J. H., Gilmer, T., Godino, J., Savin, K. L., et al. (2024) · Annals of Behavioral Medicine · doi:10.1093/abm/kaae077 · Cited by 5
Self-citationLever, C. S., Williman, J. A., Boucsein, A., Watson, A. S., Sampson, R. S., Sergel‐Stringer, O. T., Keesing, C., Wheeler, B. J., de Bock, M. I., & Paul, R. G. (2025) · Diabetic Medicine · doi:10.1111/dme.70025 · Cited by 4
“…controlled trial data on the benefits of modern real-time continuous glucose monitoring (rtCGM) in individuals with insulin-requiring type 2 diabetes include the inclusion of participants who were only on basal insulin 4 and those whose non-insulin glucose-lowering therapies had not been optimised.”
Enhancing Type 2 Diabetes Care With CGM Integration: Insights From an Italian Expert Group
Irace, C., Avogaro, A., Bertuzzi, F., Buzzetti, R., Candido, R., Prato, S. D., Bartolo, P. D., Fiorina, P., Giorda, C. B., & Giorgino, F. (2025) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.70059 · Cited by 4
“In a randomized clinical trial [51] carried out at 15 U.S. primary care centres 175 patients treated with basal insulin were randomized to CGM versus SMBG (2:1).”
Norton, B. C., Papaefthymiou, A., Telese, A., Simons-Linares, C. R., Vargo, J., Sharma, V. K., & Haidry, R. J. (2025) · Frontline Gastroenterology · doi:10.1136/flgastro-2025-103211 · Cited by 4
“21 32 We know that frequent monitoring with CGM can have a significant impact on diabetic control with a −0.4% difference reported in one RCT. 36 Weight loss may also be a factor across the studies, although we did not formally assess it in our meta-analysis.”
InfluentialNemlekar, P. M., Hannah, K. L., Green, C. R., & Norman, G. J. (2025) · Endocrinology Diabetes & Metabolism · doi:10.1002/edm2.70089 · Cited by 4
O'Connor, M. J., Ding, X., Hernandez, C., Hubacz, L., Church, R. J., & O'Connor, L. C. (2023) · Endocrine Practice · doi:10.1016/j.eprac.2023.11.001 · Cited by 4
Low-Carbohydrate and Ketogenic Dietary Patterns for Type 2 Diabetes Management
Oh, R. (2024) · Federal Practitioner · doi:10.12788/fp.0429 · Cited by 5
“38,39 It is currently unknown if CGMs improve long-term glycemic control, but they appear promising for managing and reducing medications for those on an LC diet.”
BackgroundManagement of Outpatients With Diabetes at High Risk of Hypoglycemia
Thomas, C. C., Chopra, K. A., & Davis, A. M. (2024) · JAMA · doi:10.1001/jama.2024.1137 · Cited by 4
Morris-Murray, M., & Frazzitta, M. A. (2024) · Journal of Managed Care & Specialty Pharmacy · doi:10.18553/jmcp.2024.30.10-b.s30 · Cited by 5
Continuous Glucose Monitoring Use in Youth with Type 2 Diabetes: A Pilot Randomized Study
Patel, T., Sala, N. G. L., Macheret, N. A., Glaros, S. B., Dixon, S. A., Meyers, A. G., Mackey, E. R., Estrada, E., & Chung, S. T. (2025) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2024.0539 · Cited by 4
Strategies to Reduce Iatrogenic Hypoglycemia and Hypotension in Vulnerable Older Adults
Ouslander, J. G., & Wasserman, M. R. (2025) · Journal of the American Geriatrics Society · doi:10.1111/jgs.70038 · Cited by 4
TERKEŞ, N., Bektaş, H., & Aydemir, M. (2025) · Primary care diabetes · doi:10.1016/j.pcd.2025.09.002 · Cited by 7
Abrahami, D., Hernández–Díaz, S., Munshi, M. N., & Patorno, E. (2023) · Journal of General Internal Medicine · doi:10.1007/s11606-023-08193-5 · Cited by 5
Borges, L. P., de Jesus, P. C., de Souza, J. B., Silva, D. M. R. R., Moura, P. H. M., Santos, R. S., Barreto, M. D. S., Guimarães, A. G., Santana, L. A. D. M., Fonseca, D. L. M., et al. (2024) · Life · doi:10.3390/life14030320 · Cited by 4
Cowart, K., & Carris, N. W. (2021) · JAMA · doi:10.1001/jama.2021.13472 · Cited by 4
Zooming In, Then Out: Why We Must Apply Human-Centered Design to Transform Diabetes Technology
Chao, E. C. (2023) · Journal of Diabetes Science and Technology · doi:10.1177/19322968231213665 · Cited by 3
Rickards, G. M., Harrod, J. C., Valle, K. L. D., Caballero, A. E., Palermo, N. E., & McDonnell, M. E. (2024) · Journal of Diabetes Science and Technology · doi:10.1177/19322968241288917 · Cited by 4
Satisfaction with Continuous Glucose Monitoring in Pregnant Patients with Type 1 and Type 2 Diabetes
Shrestha, K. S., & Battarbee, A. N. (2024) · American Journal of Perinatology · doi:10.1055/a-2442-7090 · Cited by 3
Flint, K. L., Fiore, M., Justice, A., Carney, J., Colling, C., Li, J. H., & Putman, M. S. (2025) · Journal of General Internal Medicine · doi:10.1007/s11606-025-09449-y · Cited by 3
Wilmot, E. G., Ajjan, R., Cheah, Y. S., Choudhary, P., CRANSTON, I. C., Elliott, R. A., Evans, M. L., Iqbal, A., Kamaruddin, S., Barnard-Kelly, K. D., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-090154 · Cited by 3
“20 While this study included approximately 27% of participants treated with basal insulin plus SGLT-2 inhibitors and/or GLP-1 agonists, there have been no RCTs conducted to date that assess the benefit of CGM specifically in this population.”
Behnke, A., Lucas, K. S., Parkin, C. G., Reddy, V., Orlowski, M., & Edwards, A. (2025) · Diabetes Spectrum · doi:10.2337/ds24-0085 · Cited by 3
Self-citationOriot, P., Bui, L., kurz, N. K. D., Gavriliu, M. M., Negrea, M.-C., & Hermans, M. P. (2025) · Acta Clinica Belgica · doi:10.1080/17843286.2025.2528030 · Cited by 3
Lilly, A. N., King, C. A., & Ortiz, J. (2025) · JACCP JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY · doi:10.1002/jac5.70090 · Cited by 3
“…have shown benefits of continuous glucose monitors (CGMs) through improvements in DM-related outcomes such as hemoglobin A1c (A1c), time in range (TIR), patient quality of life, satisfaction, work absentee-ism, and decreased time below range (level 1 hypoglycemia) and hospitalization rates [4–18].”
Lazzaroni, E., Cimino, V., Gandolfi, A., Tinari, C., Bucciarelli, L. G., Morpurgo, P. S., Nasr, M. B., Fiorina, R. M., Pastore, I., Baruffaldi, L., et al. (2026) · Journal of the Endocrine Society · doi:10.1210/jendso/bvaf165 · Cited by 3
Sharma, A. K., Lee, A., Mehta, S., Panjwani, Q., & Burugapalli, B. S. (2026) · Diabetes Technology & Therapeutics · doi:10.1177/15209156261423934 · Cited by 3
Diabetes technology: an update
Prahalad, P., Zaharieva, D. P., & Maahs, D. M. (2026) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgag164 · Cited by 4
Silva, K., Valero, P., Espinoza, F., Rivas, J. C., Sauceda-Acosta, D., & Sobrevía, L. (2026) · Handbook of experimental pharmacology · doi:10.1007/164_2026_803 · Cited by 3
Xu, H., Li, C., Li, J., Zhang, F., Wang, W., Liang, T., Liu, X., & Fu, C. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.975544 · Cited by 3
“Continuous glucose monitoring (15), monotherapy and good adherence (12), and health education (16) were found to have positive impacts on the achievement of good glycemic control.”
BackgroundLarson, R., Philbrick, A. M., Carlin, C., & Harris, I. M. (2023) · Journal of Pharmacy Technology · doi:10.1177/87551225231194027 · Cited by 3
Optimizing Glucose Sensor Calibration With Lightweight Neural Networks: A Comparative Study
Cenerini, C., Sabatini, A., Vollero, L., & Pau, D. P. (2024) · IEEE Sensors Letters · doi:10.1109/lsens.2024.3436630 · Cited by 4
“1109/LSENS.2024.3436630 this second approach, which is currently used by the majority of diabetic people, are potential inaccuracies, sensor drift over time, and susceptibility to environment influences, and they are still the object of study by research [5].”
BackgroundInfluentialCGM-Based Blood Glucose Prediction Model With LSTM Encoder–Decoder Architecture
Xu, H., Zhang, Y., Liu, S., Ji, Y., Lv, M., & Li, P. (2024) · IEEE Sensors Journal · doi:10.1109/jsen.2024.3517554 · Cited by 3
“CGMS uses glucose sensors to continuously monitor glucose concentrations in interstitial fluid, enabling direct feedback on blood glucose levels and continuous, dynamic tracking of blood glucose fluctuations [6].”
Mohan, V., Kalra, S., Augustine, A., & Kober, J. (2025) · Diabetes Therapy · doi:10.1007/s13300-025-01768-x · Cited by 3
“This was especially valuable in cases of inconsistent monitoring, where traditional lab tests were insufficient [30, 31].”
Myśliwiec, M., Czupryniak, L., Gellert, R., Jankowski, P., Mastalerz–Migas, A., Rękas, M., Strojek, K., & Walczak, M. (2025) · Diabetes Therapy · doi:10.1007/s13300-025-01769-w · Cited by 4
Willis, H. J., Gustafson, S. K., Johnson, E. M., JaKa, M. M., & Bergenstal, R. M. (2025) · Diabetes Technology & Therapeutics · doi:10.1177/15209156251377799 · Cited by 3
Self-citationExpert Opinion Statement on Continuous Glucose Monitoring in Type 2 Diabetes in the Arab Gulf Region
Alshaikh, A., BAKHSH, A. M. K., Alsagheir, A., El-Laboudi, A. H., Al-Mohanadi, D. H., Alawadi, F., Elbadawi, H., Alzubaidi, L. M. Y., Al‐Sofiani, M. E., Farooqi, M. H., et al. (2025) · Journal of Diabetes Science and Technology · doi:10.1177/19322968251393740 · Cited by 4
Metadata
- Authors
- Martens, T., Beck, R. W., Bailey, R., Ruedy, K. J., Calhoun, P., Peters, A. L., Pop-Busui, R., Philis-Tsimikas, A., Bao, S., Umpierrez, G., Davis, G., Kruger, D., Bhargava, A., Young, L., McGill, J. B., Aleppo, G., Nguyen, Q. T., Orozco, I., Biggs, W., Lucas, K. J., Polonsky, W. H., Buse, J. B., Price, D., Bergenstal, R. M., MOBILE Study Group, Carlson, A., Chambers, S., Yang, S., Kirkman, M. S., Kass, A., Fraser, R., Cushman, T., Ramos, C., Magar, M., Walker, M., Serafin-Dokhan, S., Salam, M., Hurst, S., Clifton, M. J., Kravarusic, J., Bansal, A., Fulkerson, C., Ang, L., Richardson, C., Mizokami-Stout, K., Reiss, J., Leone, V., Stifel, K., Dailey, G., Change, A., McCallum, J., Garcia, M. I., Davis, D., Lovell, C., Root, C., Toler, F., Wilhelm, L., Eifert, R., Murguia, L., Cota, B., Nguyen, L., Lipski, R., Lawrence, M. K., Fournier, A., Carter, M., Hoover, S., Cohen, N., Mouse, T., Rusnak, J., Campos, T., Njeru, N., Arant, T., Beck, S. E., & Balo, A.
- Affiliations
- Park Nicollet Health Services (US)
- Jaeb Center for Health Research (US)
- University of Southern California (US)
- University of Michigan, Ann Arbor
- Scripps Whittier Diabetes Institute, San Diego, California
- Vanderbilt University Medical Center (US)
- Emory University (US)
- Henry Ford Health (US)
- Iowa Diabetes Research, West Des Moines
- University of North Carolina at Chapel Hill (US)
- Washington University in St. Louis (US)
- Northwestern University (US)
- Las Vegas Endocrinology, Henderson, Nevada
- Carteret General Hospital (US)
- Amarillo Medical Specialists, Amarillo, Texas
- Diabetes & Endocrinology Consultants PC, Morehead City, North Carolina
- Behavioral Diabetes Institute, San Diego, California
- Dexcom (United States) (US)
- HealthPartners (US)
- for the MOBILE Study Group
- Corresponding author
- Beck, Roy W.
- ORCID
- Martens, Thomas
- Beck, Roy W.
- Bailey, Ryan
- Calhoun, Peter
- Peters, Anne L.
- Bao, Shichun
- Umpierrez, Guillermo
- Davis, Georgia
- Kruger, Davida
- Bhargava, Anuj
- Young, Laura
- McGill, Janet B.
- Aleppo, Grazia
- Polonsky, William H.
- Buse, John B.
- Price, David
- Bergenstal, Richard M.
- Carlson, Anders
- Yang, Shoua
- Kirkman, Marian Sue
- Serafin-Dokhan, Sara
- Salam, Maamoun
- Ang, Lynn
- Richardson, Caroline
- Leone, Virginia
- Dailey, George
- Hoover, Stephanie
- Cohen, Nathan
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2021-06-08
- Volume
- 325
- Issue
- 22
- Pages
- 2262
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8173473
- OpenAlex
- W3164064295
- Cited by
- 543
- References
- 23
- Citations by year
- 2026: 116 · 2025: 132 · 2024: 107 · 2023: 98 · 2022: 65 · 2021: 24
- FWCI
- 54.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001422)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926, P30DK020572, P30DK124723, P30DK111022)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- continuous glucose monitoring, type 2 diabetes, basal insulin, glycemic control, HbA1c, blood glucose meters, time in target glucose range, primary care, intensive insulin therapy, glycemic variability, hypoglycemia, hyperglycemia, HbA1c reduction, HbA1c variability
- MeSH terms
- Glycemic Control, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Time Factors, Confidence Intervals, Treatment Outcome, Patient Satisfaction, Sample Size, Postprandial Period
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