Richard E Pratley1, Lauren G Kanapka2, Michael R Rickels3, Andrew Ahmann4, Grazia Aleppo5, Roy Beck2, Anuj Bhargava6, Bruce W Bode7, Anders Carlson8, Naomi S Chaytor9, D Steven Fox10, Robin Goland11, Irl B Hirsch12, Davida Kruger13, Yogish C Kudva14, Carol Levy15, Janet B McGill16, Anne Peters17, Louis Philipson18, Athena Philis-Tsimikas19, Rodica Pop-Busui20, Viral N Shah21, Michael Thompson22, Francesco Vendrame23, Alandra Verdejo2, Ruth S Weinstock24, Laura Young25, Kellee M Miller2. 1. AdventHealth Translational Research Institute, Orlando, Florida. 2. Jaeb Center for Health Research, Tampa, Florida. 3. Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia. 4. Oregon Health and Science University, Portland. 5. Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 6. Iowa Diabetes and Endocrinology Research Center, Des Moines. 7. Atlanta Diabetes Associates, Atlanta, Georgia. 8. Park Nicollet International Diabetes Center, Minneapolis, Minnesota. 9. Elson S. Floyd College of Medicine, Washington State University, Spokane. 10. University of South California, School of Pharmacy, Los Angeles. 11. Naomi Berri Diabetes Center, Columbia University, New York, New York. 12. University of Washington, Seattle. 13. Henry Ford Health System, Detroit, Michigan. 14. Mayo Clinic, Rochester, Minnesota. 15. Icahn School of Medicine at Mount Sinai, New York, New York. 16. Washington University School of Medicine in St Louis, St Louis, Missouri. 17. Keck School of Medicine, University of Southern California, Los Angeles. 18. University of Chicago, Chicago, Illinois. 19. Scripps Whittier Diabetes Institute, La Jolla, California. 20. University of Michigan, Ann Arbor. 21. Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora. 22. University of Massachusetts Medical School, Worcester. 23. University of Miami, Miami, Florida. 24. SUNY Upstate Medical University, Syracuse, New York. 25. University of North Carolina at Chapel Hill, Chapel Hill.
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. MeanHbA1c 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.
RCT Entities:
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.
Authors: Marcus Lind; William Polonsky; Irl B Hirsch; Tim Heise; Jan Bolinder; Sofia Dahlqvist; Erik Schwarz; Arndís Finna Ólafsdóttir; Anders Frid; Hans Wedel; Elsa Ahlén; Thomas Nyström; Jarl Hellman Journal: JAMA Date: 2017-01-24 Impact factor: 56.272
Authors: Kasia J Lipska; Joseph S Ross; Yun Wang; Silvio E Inzucchi; Karl Minges; Andrew J Karter; Elbert S Huang; Mayur M Desai; Thomas M Gill; Harlan M Krumholz Journal: JAMA Intern Med Date: 2014-07 Impact factor: 21.873
Authors: Rosanna Fiallo-Scharer; Jing Cheng; Roy W Beck; Bruce A Buckingham; H Peter Chase; Craig Kollman; Lori Laffel; Jean M Lawrence; Nelly Mauras; William V Tamborlane; Darrell M Wilson; Howard Wolpert Journal: Diabetes Care Date: 2011-01-25 Impact factor: 19.112
Authors: Grazia Aleppo; Katrina J Ruedy; Tonya D Riddlesworth; Davida F Kruger; Anne L Peters; Irl Hirsch; Richard M Bergenstal; Elena Toschi; Andrew J Ahmann; Viral N Shah; Michael R Rickels; Bruce W Bode; Athena Philis-Tsimikas; Rodica Pop-Busui; Henry Rodriguez; Emily Eyth; Anuj Bhargava; Craig Kollman; Roy W Beck Journal: Diabetes Care Date: 2017-02-16 Impact factor: 19.112
Authors: Rose A Gubitosi-Klug; Barbara H Braffett; Ionut Bebu; Mary L Johnson; Kaleigh Farrell; David Kenny; Victoria R Trapani; Lynne Meadema-Mayer; Elsayed Z Soliman; Rodica Pop-Busui; John M Lachin; Richard M Bergenstal; William V Tamborlane Journal: Diabetes Care Date: 2022-03-01 Impact factor: 19.112
Authors: Boris Draznin; Vanita R Aroda; George Bakris; Gretchen Benson; Florence M Brown; RaShaye Freeman; Jennifer Green; Elbert Huang; Diana Isaacs; Scott Kahan; Jose Leon; Sarah K Lyons; Anne L Peters; Priya Prahalad; Jane E B Reusch; Deborah Young-Hyman Journal: Diabetes Care Date: 2022-01-01 Impact factor: 19.112