Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

Kellee M Miller¹, Lauren G Kanapka¹, Michael R Rickels², Andrew J Ahmann³, Grazia Aleppo⁴, Lynn Ang⁵, Anuj Bhargava⁶, Bruce W Bode⁷, Anders Carlson⁸, Naomi S Chaytor⁹, Gail Gannon¹⁰, Robin Goland¹¹, Irl B Hirsch¹², Lisa Kiblinger⁷, Davida Kruger¹³, Yogish C Kudva¹⁴, Carol J Levy¹⁵, Janet B McGill¹⁶, Grenye O'Malley¹⁵, Anne L Peters¹⁷, Louis H Philipson¹⁰, Athena Philis-Tsimikas¹⁸, Rodica Pop-Busui⁵, Maamoun Salam¹⁶, Viral N Shah¹⁹, Michael J Thompson²⁰, Francesco Vendrame²¹, Alandra Verdejo¹, Ruth S Weinstock²², Laura Young²³, Richard Pratley²⁴

Affiliations

¹ Jaeb Center for Health Research, Tampa, Florida, USA.
² Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
³ Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland, Oregon, USA.
⁴ Division of Endocrinology, Metabolism, and Molecular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
⁵ Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.
⁶ Iowa Diabetes and Endocrinology Research Center, Des Moines, Iowa, USA.
⁷ Formally Atlanta Diabetes Associates, Atlanta, Georgia, USA.
⁸ Park Nicollet International Diabetes Center, Minneapolis, Minnesota, USA.
⁹ Elson S. Floyd College of Medicine, Washington State University, Spokane, Washington, USA.
¹⁰ Kovler Diabetes Center, University of Chicago, Chicago, Illinois, USA.
¹¹ Naomi Berri Diabetes Center, Columbia University, New York, New York, USA.
¹² Division of Metabolism, Endocrinology and Nutrition, University of Washington, Seattle, Washington, USA.
¹³ Henry Ford Health System, Detroit, Michigan, USA.
¹⁴ Mayo Clinic, Rochester, Minnesota, USA.
¹⁵ Division of Endocrinology, Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹⁶ Division of Endocrinology, Metabolism & Lipid Research, John T. Milliken Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
¹⁷ Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.
¹⁸ Scripps Whittier Diabetes Institute, La Jolla, California, USA.
¹⁹ Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
²⁰ Department of Endocrinology-Diabetes, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
²¹ Division of Endocrinology, Diabetes, and Metabolism at the University of Miami School of Medicine, University of Miami, Miami, Florida, USA.
²² Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA.
²³ Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
²⁴ AdventHealth Translation Research Institute, Orlando, Florida, USA.

PMID: 35294272
PMCID: PMC9208859
DOI: 10.1089/dia.2021.0503

Randomized Controlled Trial

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

Kellee M Miller et al. Diabetes Technol Ther. 2022 Jun.

. 2022 Jun;24(6):424-434.

doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11.

Authors

Affiliations

¹ Jaeb Center for Health Research, Tampa, Florida, USA.
² Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
³ Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland, Oregon, USA.
⁴ Division of Endocrinology, Metabolism, and Molecular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
⁵ Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.
⁶ Iowa Diabetes and Endocrinology Research Center, Des Moines, Iowa, USA.
⁷ Formally Atlanta Diabetes Associates, Atlanta, Georgia, USA.
⁸ Park Nicollet International Diabetes Center, Minneapolis, Minnesota, USA.
⁹ Elson S. Floyd College of Medicine, Washington State University, Spokane, Washington, USA.
¹⁰ Kovler Diabetes Center, University of Chicago, Chicago, Illinois, USA.
¹¹ Naomi Berri Diabetes Center, Columbia University, New York, New York, USA.
¹² Division of Metabolism, Endocrinology and Nutrition, University of Washington, Seattle, Washington, USA.
¹³ Henry Ford Health System, Detroit, Michigan, USA.
¹⁴ Mayo Clinic, Rochester, Minnesota, USA.
¹⁵ Division of Endocrinology, Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹⁶ Division of Endocrinology, Metabolism & Lipid Research, John T. Milliken Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
¹⁷ Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.
¹⁸ Scripps Whittier Diabetes Institute, La Jolla, California, USA.
¹⁹ Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
²⁰ Department of Endocrinology-Diabetes, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
²¹ Division of Endocrinology, Diabetes, and Metabolism at the University of Miami School of Medicine, University of Miami, Miami, Florida, USA.
²² Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA.
²³ Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
²⁴ AdventHealth Translation Research Institute, Orlando, Florida, USA.

PMID: 35294272
PMCID: PMC9208859
DOI: 10.1089/dia.2021.0503

Abstract

Objective: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. Research Design and Methods: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. Results: CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks (P < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%; P < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol]; P = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% (P < 0.001), TIR increased from 56% to 60% (P = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) (P = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM (P = 0.02). Conclusions: CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432).

Keywords: CGM use; Hyperglycemia; Hypoglycemia; Older adults.

PubMed Disclaimer

Conflict of interest statement

K.M.M. reports nonfinancial support of supplies provided from Dexcom. L.G.K. has nothing to disclose. M.R.R. reports grants from Xeris Pharmaceuticals, personal fees from Semma Therapeutics, and personal fees from Sernova Corporation. A.J.A. reports grants from Dexcom and personal fees from Medtronic. G.A. reports grants from Novo Nordisk, grants from Dexcom, grants from Astra Zeneca, grants from Eli Lilly, grants from Insulet, personal fees from Dexcom, and personal fees from Insulet. LA has nothing to disclose.

A.B. reports grants and other from Sanofi, grants and other from Astra Zeneca, grants and other from Eli Lilly, grants from United BioSource Corporation, grants from Abbott Diabetes Care, grants from Abbvie, grants from Insulet Corporation, grants from Dexcom, grants from Teijin America, Inc., grants from Bayer Healthcare Pharmaceuticals, Inc., grants from Boehringer Ingelheim, grants from Bristol-Meyers Squibb Research and Development, grants from Gan & Lee Pharmaceuticals, grants from JAEB Center for Health Research, grants from KOWA Research Institute, Inc., grants from Medtronic MiniMed, grants from Mylan GmbH, grants from Novo Nordisk, and grants from Theracos Sub LLC outside the submitted work.

B.W.B. reports grants from the employer from Abbott Diabetes Care, Bio-Provention, DexCom, Diasome, Insulet, Janssen, JAEB Center for Health Research, Eli Lilly, Medtronic, Novo Nordisk, Sanvita, Senseonics, Sanofi, Viacyte, and Xeris. B.W.B. has received personal fees for consulting and speaking from Astra Zeneca, Big Foot, Companion Medical, Eli Lilly, MannKind, Medronic, Novo Nordisk, Sanofi, Senseonics, Xeris and Zealand.

A.C. reports grants and other from Novo Nordisk, grants and other from Medtronic, grants and other from Insulet, grants and other from Sanofi, grants from Dexcom, grants and other from Abbott, other from Senseonics, grants and other from Eli Lilly, and grants from UnitedHealth outside the submitted work; in addition, A.C. has a patent to U.S. Provisional Patent Application Serial No. 62/443,004 pending. N.S.C. reports personal fees from Eli Lilly, Inc. G.G. has nothing to disclose. R.G. has nothing to disclose. I.B.H. receives research funding from Medtronic Diabetes, Insulet, and Beta Bionics, and reports consulting from Abbott Diabetes Care and Bigfoot. L.K. reports contract with Lifescan, affiliation with Voluntis. D.K. reports grants and personal fees from Dexcom outside the submitted work. Y.C.K. reports product support from Dexcom and Roche Diabetes and consulting with Novo.

C.J.L. reports grant support from Abbott Diabetes, and grant support and nonfinancial support from Dexcom outside the submitted work, grant support from Insulet, and personal fess from Eli Lilly, Inc. J.B.M. reports personal fees and nonfinancial support from Bayer, personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from Lilly, personal fees from Mannkind, personal fees from Novo Nordisk, personal fees from Salix, and grants and personal fees from Dexcom, grants from Medtronic, grants from NIH, and grants from Leona Helmsley Trust. G.O.M. reports grant support from Abbott Diabetes, and grant support and nonfinancial support from Dexcom outside the submitted work, and grant support from Insulet.

A.P. reports personal fees from Medscape, grants from Dexcom and devices for research received from Abbott Diabetes Care, personal fees from Abbot Diabetes Care, personal fees from MannKind, personal fees from NovoNordisk, personal fees from Eli Lilly, personal fees from Merck, personal fees from Zealand; and Stock options: Omada Health and Teladoc. L.H.P. has nothing to disclose. A.P.T. reports nonfinancial support from Dexcom. R.P.B. reports grants from Dexcom outside the submitted work. M.S. reports personal fees from Lilly. V.N.S. reports receiving research support through University of Colorado from Eli-Lilly, NovoNordisk, Sanofi, Dexcom, vTv therapeutics, Mylan GmbH, and Insulet. V.N.S. also served on advisory board of Sanofi and Medscape LLC. M.J.T. has nothing to disclose. F.V. reports a grant from Tolerion, Inc.

A.V. has nothing to disclose. R.S.W. reports grants from Insulet Corporation, grants from Tolerion, Inc., grants from Eli Lilly and Co, grants from Medtronic, grants from Diasome Pharmaceuticals, and grants from Boehringer Ingelheim. L.A.Y. reports grants from Dexcom, vTv therapeutics, NovoNordisk, Boehringer Ingelheim, Bayer, Sanofi US, Johnson and Johnson, Eli Lilly and Lexicon. R.P. reports grants from Hanmi Pharmaceutical Co.; grants from Janssen; consulting fees from Merck; grants, speaker fees and consulting fees from Novo Nordisk; consulting fees from Pfizer; grants from Poxel SA; grants and consulting fees from Sanofi; consulting fees from Scohia Pharma, Inc.; consulting fees from Sun Pharmaceutical Industries. Fees and honoraria for Dr. Richard Pratley's services were paid for directly to AdventHealth, a nonprofit organization.

Figures

**FIG. 1.**
**(A)** Boxplots of percent of time spent below 70 mg/dL by visit. Light gray represents CGM-CGM group. Dark gray represents BGM-CGM group. The top and bottom of the boxes denote the 25th and 75th percentile, the line represents the median and the dot the mean. **(B)** Boxplots of Percent of time spent in range 70–180 mg/dL by Visit. Light gray represents CGM-CGM group. Dark gray represents BGM-CGM group. The top and bottom of the boxes denote the 25th and 75th percentile, the line represents the median and the dot the mean. BGM, blood glucose monitoring; CGM, continuous glucose monitoring; BGM-CGM, BGM group participants initiated CGM; CGM-CGM, CGM group participants continued CGM.

See this image and copyright information in PMC

References

1. Chow L, Seaquist ER: How significant is severe hypoglycemia in older adults with diabetes? Diabetes Care 2020;43:512–514. - PMC - PubMed
1. Lipska KJ, Ross JS, Wang Y, et al. : National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med 2014;174:1116–1124. - PMC - PubMed
1. Pratley RE, Kanapka LG, Rickels MR, et al. ; Wireless innovation for seniors with Diabetes Mellitus Study Group: Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial. JAMA 2020;323:2397–2406. - PMC - PubMed
1. The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986. - PubMed
1. Battelino T, Danne T, Bergenstal RM, et al. : Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 2019;42:1593–1603. - PMC - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

Affiliations

Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding