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Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial

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Pratley, Richard E., Kanapka, Lauren G., Rickels, Michael R., Ahmann, Andrew, Aleppo, Grazia, Beck, Roy, Bhargava, Anuj, Bode, Bruce W. +21 more·2020·JAMA

Abstract

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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Crossref · 10.1001/jama.2020.6928

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  • Emerging evidence indicates that CGM is efficacious in reducing hyperglycemia and A1C levels in insulin-treated people with T2D, including those taking one or two doses of basal insulin.

    “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]

    The Glycemic Control Outcomes section reports reduced hyperglycemia and HbA1c with CGM compared with standard blood glucose monitoring. But the Participants section specifies adults aged 60 or older with type 1 diabetes using an insulin pump or multiple daily injections; this study does not establish the claim for people with type 2 diabetes or those taking one or two doses of basal insulin. Page numbers were not available in our copy. (LLM, conf=0.90)

    Experimental — accuracy not yet measured
  • Emerging evidence suggests benefits of continuous glucose monitoring use in insulin-treated persons with type 2 diabetes.

    “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]

    The Key Points and Discussion report a small reduction in hypoglycemia with CGM in insulin-treated older adults with type 1 diabetes, not type 2 diabetes. The References list a trial involving adults with both types, but this paper does not report its type 2 findings; the claimed benefit in insulin-treated people with type 2 diabetes is therefore not established by this source. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • Among secondary outcomes in the WISDM trial, time spent in range between 70 and 180 mg/dL increased by 8% and glycemic variability decreased.

    “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: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [39]

    The Glycemic Control Outcomes section reports that time in the 70–180 mg/dL range was 8.8 percentage points higher with CGM than with standard blood glucose monitoring (95% CI, 6.0–11.5), not 8%. Table 2 also reports a lower coefficient of variation, supporting the claim about decreased glycemic variability. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • Among secondary outcomes in WISDM, time spent in range between 70 and 180 mg/dL increased by 8% and glycemic variability decreased.

    “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]

    The Glycemic Control Outcomes section reports that time in the 70–180 mg/dL range was 8.8 percentage points higher with CGM than with standard blood glucose monitoring, with the cited 95% CI of 6.0–11.5. Table 2 also reports a decrease in glycemic variability (%CV). The citing sentence gives the increase as 8% rather than 8.8%. (LLM, conf=0.88)

    Experimental — accuracy not yet measured
  • The use of advanced technologies in older individuals is useful.

    “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]

    The Discussion (page not available in our copy) reports that continuous glucose monitoring modestly reduced hypoglycemia in adults aged 60 or older with type 1 diabetes. That supports the usefulness of this technology in the studied group, but not a claim about advanced technologies generally or a recommendation against discontinuing them or excluding people from them solely because of age. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

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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.
Venue
JAMA
Published
2020-06-16
Volume
323
Issue
23
Pages
2397
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W3034989043
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
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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