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Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial
Open accessAbstract
Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT03240432.
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“There is emerging evidence that CGM is efficacious in reducing hyperglycemia and A1C levels in insulin-treated persons with T2D, including those taking 1 or 2 doses of basal insulin.169–172”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [170]
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
“Emerging evidence suggests benefits of CGM use in insulin-treated persons with T2D170,1074”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [170]
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
“Among secondary outcomes, time spent in range between 70 and 180 mg/dL increased by 8% (95% CI 6.0-11.5)and glycemic variability (%CV) decreased.”
From 13. Older Adults: Standards of Care in Diabetes—2024 (2024) · cites this paper as [39]
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
“Among secondary outcomes, time spent in range between 70 and 180 mg/dL increased by 8% (95% CI 6.0-11.5)and glycemic variability (%CV) decreased.”
From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [41]
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
“The use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (78,274).”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [78]
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“Compared to capillary blood glucose monitoring, real-time continuous glucose monitoring has been shown to consistently improve glycaemic metrics in children,14 adolescents15 and adults,16 including older adults,17 with type 1 diabetes.”
From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [17]
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In the citing paper
“Although most RCTs have not been powered to detect reductions in the rate of severe hypoglycemia, a study in people over the age of 60 with type 1 diabetes (a population at high risk of hypoglycemia) showed significant reductions in both time in the hypoglycemic range and severe hypoglycemic events (162).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [162]
The cited source says what the claim attributes to it.
In the citing paper
“Over 6 months, use of CGM resulted in a small but statistically significant reduction in time spent with hypoglycemia (glucose level <70 mg/dL) compared with standard blood glucose monitoring (adjusted treatment difference À1.9% [À27 min/day]; 95% CI À2.8% to À1.1% [À40 to À16 min/day]; P < 0.001) (38,39).”
From 13. Older Adults: Standards of Care in Diabetes—2024 (2024) · cites this paper as [39]
The cited source says what the claim attributes to it.
In the citing paper
“Over 6 months, use of CGM resulted in a small but statistically significant reduction in time spent with hypoglycemia (glucose level <70 mg/dL) compared with standard blood glucose monitoring (adjusted treatment difference À1.9% [À27 min/day]; 95% CI À2.8% to À1.1% [À40 to À16 min/day]; P < 0.001) (40,41).”
From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“Continuous glucose monitoring (CGM) devices have been shown to be effective at improving glycemic management and acceptable to people of all age-groups, including older individuals with type 1 diabetes (44–48) or insulin-requiring type 2 diabetes (49,50).”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [45]
The cited source says what the claim attributes to it.
In the citing paper
“Continuous glucose monitoring (CGM) devices have been shown to be effective at improving glycemic management and acceptable to people of all age-groups, including older individuals with type 1 diabetes (44–48) or insulin-requiring type 2 diabetes (49,50).”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [45]
The cited source says what the claim attributes to it.
In the citing paper
“rt-CGM is beneficial in reducing the burden of hypoglycemia in older adults with type 1 diabetes (78) and those with IAH (44).”
In the citing paper
“The primary outcome was met and showed benefit in adults of all ages (38,53,54), including seniors (55-57).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [55]
In the citing paper
“A report in people with type 1 diabetes over the age of 60 years revealed a small but statistically significant decrease in hypoglycemia (125).”
From 6. Glycemic Targets: Standards of Care in Diabetes—2023 (2023) · cites this paper as [125]
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Metadata
- Authors
- Pratley, R. E., Kanapka, L. G., Rickels, M. R., Ahmann, A., Aleppo, G., Beck, R., Bhargava, A., Bode, B. W., Carlson, A., Chaytor, N. S., Fox, D. S., Goland, R., Hirsch, I. B., Kruger, D., Kudva, Y. C., Levy, C., McGill, J. B., Peters, A., Philipson, L., Philis-Tsimikas, A., Pop-Busui, R., Shah, V. N., Thompson, M., Vendrame, F., Verdejo, A., Weinstock, R. S., Young, L., Miller, K. M., & for the Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group
- Affiliations
- AdventHealth Orlando (US)
- Jaeb Center for Health Research (US)
- University of Pennsylvania Health System (US)
- Oregon Health & Science University (US)
- Northwestern University (US)
- Iowa Diabetes and Endocrinology Research Center (US)
- Atlanta Diabetes Associates (US)
- Park Nicollet Health Services (US)
- Washington State University Spokane (US)
- University of Southern California (US)
- Columbia University (US)
- University of Washington (US)
- Henry Ford Health (US)
- Mayo Clinic (US)
- Icahn School of Medicine at Mount Sinai (US)
- Washington University in St. Louis (US)
- University of Chicago (US)
- Scripps Whittier Diabetes Institute, La Jolla, California
- University of Michigan, Ann Arbor
- University of Colorado Anschutz (US)
- University of Massachusetts Chan Medical School (US)
- University of Miami (US)
- SUNY Upstate Medical University (US)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Pratley, Richard E.
- ORCID
- Pratley, Richard E.
- Kanapka, Lauren G.
- Rickels, Michael R.
- Ahmann, Andrew
- Aleppo, Grazia
- Beck, Roy
- Bhargava, Anuj
- Bode, Bruce W.
- Carlson, Anders
- Chaytor, Naomi S.
- Fox, D. Steven
- Hirsch, Irl B.
- Kruger, Davida
- Kudva, Yogish C.
- Levy, Carol
- McGill, Janet B.
- Peters, Anne
- Philipson, Louis
- Shah, Viral N.
- Thompson, Michael
- Vendrame, Francesco
- Verdejo, Alandra
- Weinstock, Ruth S.
- Young, Laura
- Miller, Kellee M.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-06-16
- Volume
- 323
- Issue
- 23
- Pages
- 2397
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC7298607
- OpenAlex
- W3034989043
- Semantic Scholar
- 1c097e3947a1ab456a4aec132a408f1d6419a62b
- Cited by
- 375
- References
- 28
- Citations by year
- 2026: 55 · 2025: 63 · 2024: 72 · 2023: 61 · 2022: 67 · 2021: 48 · 2020: 9
- FWCI
- 34.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- AstraZeneca
- Sanofi
- Gilead Sciences
- McGill University
- Insulet Corporation
- MannKind Corporation
- Dexcom
- Mylan
- Jaeb Center for Health Research
- Novo Nordisk
- National Institutes of Health (UL1TR001422, UL1TR001878)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK020541, P30DK020595, P30DK111022)
- National Center for Research Resources
- 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, hypoglycemia, type 1 diabetes, older adults, blood glucose monitoring, hyperglycemia, glycemic control, HbA1c, cognitive function, patient-reported outcomes, insulin pump therapy, hypoglycemia awareness, hypoglycemia treatment, hypoglycemia prevention
- MeSH terms
- Patient Reported Outcome Measures, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Male, Middle Aged, Blood Glucose Self-Monitoring, Monitoring, Ambulatory
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