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

Educational Objective
To learn the effects of continuous glucose monitoring on glycemic outcomes and patient-reported outcomes among older adults with type 1 diabetes.
1 Credit CME
Key Points

Question  Is continuous glucose monitoring effective in reducing hypoglycemia compared with standard blood glucose monitoring in older adults with type 1 diabetes?

Findings  In this randomized clinical trial that included 203 adults aged 60 years or older with type 1 diabetes, treatment for 6 months with continuous glucose monitoring compared with standard blood glucose monitoring resulted in a significantly lower percentage of glucose values less than 70 mg/dL (adjusted difference, 1.9%).

Meaning  Among older adults with type 1 diabetes, continuous glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months.

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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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: Richard E. Pratley, MD, AdventHealth Translational Research Institute, 301 E Princeton St, Orlando, FL 32789 (richard.pratley.md@adventhealth.com).

Accepted for Publication: April 16, 2020.

Author Contributions: Dr Miller had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Pratley, Rickels, Ahmann, Aleppo, Beck, Carlson, Chaytor, Fox, Goland, Hirsch, Kruger, Kudva, Peters, Pop-Busui, Shah, Verdejo, Miller.

Acquisition, analysis, or interpretation of data: Pratley, Kanapka, Rickels, Ahmann, Aleppo, Bhargava, Bode, Carlson, Chaytor, Fox, Goland, Hirsch, Kruger, Kudva, Levy, McGill, Peters, Philipson, Philis-Tsimikas, Pop-Busui, Shah, Thompson, Vendrame, Weinstock, Miller.

Drafting of the manuscript: Pratley, Kanapka, Rickels, Carlson, Kudva, Peters, Philis-Tsimikas, Thompson, Miller.

Critical revision of the manuscript for important intellectual content: Pratley, Kanapka, Rickels, Ahmann, Aleppo, Beck, Bhargava, Bode, Carlson, Chaytor, Fox, Goland, Hirsch, Kruger, Kudva, Levy, McGill, Peters, Philipson, Philis-Tsimikas, Pop-Busui, Shah, Vendrame, Verdejo, Weinstock.

Statistical analysis: Kanapka, Fox.

Obtained funding: Pratley, Miller.

Administrative, technical, or material support: Rickels, Beck, Bode, Carlson, Chaytor, Goland, Philipson, Vendrame, Verdejo, Miller.

Supervision: Pratley, Rickels, Ahmann, Aleppo, Beck, Carlson, Chaytor, Goland, Hirsch, Kudva, Levy, Peters, Philipson, Vendrame, Weinstock, Miller.

Conflict of Interest Disclosures: Dr Pratley reported lecture and/or consultancy fees and/or grants paid to his institution, AdventHealth, from AstraZeneca, Boehringer Ingelheim, Eisai Inc, GlaxoSmithKline, Glytec LLC, Janssen, Lexicon Pharmaceuticals, Ligand Pharmaceuticals Inc, Lilly, Merck, Mundipharma, Novo Nordisk, Pfizer, Sanofi, and Takeda; receipt of grants from Lexicon Pharmaceuticals, Ligand Pharmaceuticals Inc, Lilly, Merck, Novo Nordisk, Sanofi, and Takeda; and receipt of personal fees from Sanofi US Services Inc. Dr Rickels reported receipt of personal fees from Hua Medicine, Xeris Pharmaceuticals, Semma Therapeutics, and Sernova; grants from Xeris Pharmaceuticals; and nonfinancial support from Merck & Co. Dr Ahmann reported contract research payments to his institution from Dexcom and receipt of personal fees from Medtronic. Dr Aleppo reported receipt of grants from Novo Nordisk, Dexcom, AstraZeneca, and Lilly and personal fees from Dexcom, Medtronic, Insulet, and Novo Nordisk. Dr Beck reported consulting fees paint to his institution from Bigfoot Biomedical, Tandem Diabetes Care, Insulet, and Lilly and receipt of grants from Dexcom and Tandem Diabetes Care and nonfinancial support from Dexcom, Tandem Diabetes Care, Roche, and Ascensia. Dr Bhargava reported receipt of grants from Sanofi, AstraZeneca, Lilly, United BioSource Corporation, Dexcom, Teijin America Inc, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Bristol-Meyers Squibb Research and Development, Gan & Lee Pharmaceutical, the Jaeb Center for Health Research, KOWA Research Institute Inc, Medtronic MiniMed, Mylan GmbH, Novo Nordisk, AstraZeneca, Lilly, and Theracos Sub LLC; speaker fees from Sanofi, AstraZeneca, and Lilly; and consultant fees from Sanofi. Dr Carlson reported receipt of grants from Novo Nordisk, Medtronic, Insulet, Sanofi, Dexcom, Abbott, Lilly, and UnitedHealth; he reports contracts as a research investigator and/or consultant through his employer, HealthPartners Institute/International Diabetes Center at Park Nicollet (with no personal income received), with Novo Nordisk, Medtronic, Insulet, Sanofi, Abbott, Sensionics, and Lilly; in addition, Dr Carlson has a patent to US Provisional Patent Application Serial No. 62/443 004 pending. Dr Chaytor reported receipt of personal fees from Lilly. Dr Kruger reported receipt of grants and personal fees from Dexcom. Dr Levy reported receipt of nonfinancial support from Dexcom. Dr McGill reported receipt of personal fees from Aegerion, Bayer, Boehringer Ingelheim, Gilead, Lilly, Metavant, Valeritas, Janssen, Mannkind, the Endocrine Society, the American Association of Clinical Endocrinologists, Culinary Medicine, Novo Nordisk, and Dexcom; grants from Novo Nordisk, Dexcom, Medtronic, Novartis, AstraZeneca, and the NIH; and nonfinancial support from Bayer, Boehringer Ingelheim, the American Association of Clinical Endocrinologists, Mannkind, Culinary Medicine, and the Jaeb Center for Health Research. Dr Peters reported receipt of personal fees from Medscape, Sanofi, Lexicon, Becton Dickinson, Abbot Diabetes Care, Bigfoot, Mannkind, Novo Nordisk, Lilly, and Boehringer Ingelheim; grants from AstraZeneca, vTv Therapeutics, Mannkind, and Dexcom; and stock options for Mellitus Health, Omada Health, Stability Health, Pendulum Therapeutics, and Livongo. Dr Shah reported receipt of consulting fees through the University of Colorado from Dexcom and grants from vTv therapeutics, Novo Nordisk, Mylan GmbH, Sanofi US Services Inc, Insulet, and the NIH. Dr Weinstock reported receipt of grants from the Juvenile Diabetes Research Foundation, Insulet Corporation, Tolerion Inc, Lilly, Medtronic, Diasome Pharmaceuticals, Boehringer Ingelheim, Oramed Ltd, and Mylan GmbH and personal fees from Insulogic. Dr Miller reported receipt of nonfinancial support from Dexcom and Tandem. No other disclosures were reported.

Funding/Support: This study was funded by JDRF and the Leona M. and Harry B. Helmsley Charitable Trust by a grant provided to the Jaeb Center for Health Research. The National Center for Research Resources and the National Center for Advancing Translational Sciences of the NIH (grant UL1TR001878) support the Center for Human Phenomic Science at the University of Pennsylvania. Dexcom provided study CGM devices and sensors.

Role of the Funders/Sponsors: JDRF, the Leona M. and Harry B. Helmsley Charitable Trust, and Dexcom were not involved in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or in writing the original manuscript draft or revision of the manuscript. JDRF, the Leona M. and Harry B. Helmsley Charitable Trust, and Dexcom were sent the manuscript for review, but any revisions made based on their comments were at the discretion of the authors, and permission for submitting content to the journal was not required. There was no approval of JDRF, the Leona M. and Harry B. Helmsley Charitable Trust, or Dexcom required or obtained for manuscript submission.

WISDM Study Group: Participating principal investigators (PIs), coinvestigators (Is), primary coordinator (PCs), and coordinators (Cs) are listed below. All study personnel listed below were involved in data collection. Additional roles beyond data collection are noted. Icahn School of Medicine at Mt Sinai, New York, New York: Carol Levy, MD, CDE (PI); David Lam, MD (I); Grenye O’Malley, MD (I); Camilla Levister, NP, CDE (I); Nirali Shah, MD (I); Selassie Ogyaadu, MD, MPH (PC); Mayo Clinic, Rochester, Minnesota: Yogish Kudva, MD (PI); Vinaya Simha, MD (I); Shelly McCrady Spitzer (PC); Corey Reid (C); International Diabetes Center/Park Nicollet, Minneapolis, Minnesota: Anders Carlson, MD (PI); Richard Bergenstal, MD (I); Marcia Madden, MPH, RN, CNP, CDE (I); Thomas Martens, MD (I); Sean Dunnigan, RN (PC); Kathleen McCann, RN (C); University of Washington Diabetes Care Center, Seattle: Irl Hirsch, MD (PI); Dace Trence, MD, FACE (I); Subbulaxmi Trikudanathan, MD, MRCP, MMSc (I); Lorena Wright, MD (I); Andrea Toulouse, MS (PC); Dori Khakpour, RDN, CD, CDE (C); Lori Sameshima, RN (C); Nancy Sanborn, ND, CDE (C) Naomi Berrie Diabetes Center, Columbia University, New York, New York: Robin Goland, MD (PI); Lauren Golden, MD (I); Sarah Pollak, RN, MSN (PC); Courtney Melrose, MPH, RDN, CDE (C); Analia Alvarez, RN, BSN (C); Elizabeth Robinson (C); Eleanor Zagoren (C); University of North Carolina Diabetes Care Center, Chapel Hill, North Carolina: Laura Young, MD, PhD (PI); Elizabeth Harris, MD, FACE (I); John Buse, MD, PhD (I); Katherine Bergamo, BSN, MSN, FNP-C (I); Marian Sue Kirkman, MD (I); Jean Dostou, MD, FACE (I); Alexander Kass, BSN, RN, CDE (PC); Milana Dezube, BSN, RN, CDE (C); Rahul Kathard (C); Jamie C. Diner, BSN, RN, CDE (C); Henry Ford Health System, Detroit, Michigan: Davida Kruger, NP (PI); Natalie Corker (PC); Heather Remtema (C); Keck School of Medicine, University of Southern California, Los Angeles: Anne Peters, MD (PI); Mark Harmel, MPH, CDE (PC); SUNY Upstate Medical University, Syracuse, New York: Ruth Weinstock, MD, PhD (PI); Suzan Bzdick, RN, CDE (PC); Atlanta Diabetes Associates, Atlanta, Georgia: Bruce Bode, MD (PI); Jennifer Boyd, PA (I); Joseph Johnson, PA (I); Lisa Kiblinger, RN, NP-C, CDE (I); Jonathan Ownby, MD (I); Nitin Rastogi, MBBS (PC); Blake Winslett (C); Tracy Lawrence (C); Harold Schnitzer Diabetes Health Center, Oregon Health and Science University, Portland: Andrew Ahmann, MD (PI); Jessica Castle, MD (I); Farahnaz Joarder, MD (I); Diana Aby-Daniel, PA (I); Victoria Morimoto, PA (I); Kathryn Hanavan, RN, NP (I); Kristin Jahnke (PC); Rebecca Fitch (C); Brianna Moralez-Gomez (C); Washington University, St Louis, Missouri: Janet McGill, MD (PI); Maamoun Salam, MD (I); Stacy Hurst, RN, BSN, CDE (PC); Mary Jane Clifton, CCRP (C); Carol Recklein, RN, MHS, CDE (C); Toni Schweiger, RN (C); Alex Goay, BA (C); Northwestern University, Chicago, Illinois: Grazia Aleppo, MD (PI); Emily Szmuilowicz, MD (I); Elaine Massaro, MS, RN, CDE (PC); Anupam Bansal, MD (C); Division of Endocrinology, Diabetes and Metabolism, University of Miami, Miami, Florida: Francesco Vendrame, MD, PhD (PI); Natalia Sanders-Branca, MD (PC); Della Matheson, RN, CDE (C); University of Michigan, Ann Arbor: Rodica Pop-Busui, MD, PhD (PI); Lynn Ang, MD (I); Kara Mizokami-Stout, MD (I); Cynthia Plunkett, RN (PC); Brittany Plunkett (C); Virginia Leone (C); University of Pennsylvania Perelman School of Medicine/Rodebaugh Diabetes Center, Philadelphia: Michael Rickels, MD, MS (PI); Amy Peleckis, MSN, CRNP (I); Cornelia Dalton-Bakes, MS, CCRC (PC); Eileen Markmann, BSN (C); University of Massachusetts Medical School, Worcester: Michael Thompson, MD (PI); Nina Rosano, MD (I); Celia Hartigan, RN, MPH (PC); Iowa Diabetes and Endocrinology Research Center, West Des Moines: Anuj Bhargava, MD (PI); Kathleen Fitzgerald, RN (I); Kirstie Stifel (PC); Lisa Borg (C); AdventHealth, Translational Research Institute, Orlando, Florida: Richard Pratley, MD (PI); Melissa Rooney, ARNP (I); Heather Richmond, PA (I); Karthik Chivukula, MD (I); Keri Whitaker, RN (PC); Karla Flores Perez (C); University of Chicago, Chicago, Illinois: Louis Phillipson, MD, PhD (PI); Celeste Thomas, MD, MS (I); Gail Gannon, APN, FNP-C (I); Mariko Pusinello, APN, RN (C) (C); Barbara Davis Center for Diabetes, University of Colorado/Denver, Aurora: Viral Shah, MD (PI); Halis Kaan Akturk, MD (I); Hal Joseph, PA-C (I); Lisa Myers (PC); Prakriti Joshee (C); Elizabeth Beck (C); Scripps Whittier Diabetes Institute, San Diego, California: Athena Philis-Tsimikas, MD (PI); George Dailey, MD (I); Amy Chang, MD (I); James McCallum, MD (I); Maria Isabel Garcia, RN (PC); Rosario Rosal (C); Jaeb Center for Health Research, Tampa, Florida: Kellee M. Miller, PhD; Alandra Verdejo, MPH; Nicole Reese, BS; David McNabb, AS; Heidi Strayer, PhD; Kamille Janess, BS; Israel Mahr, MS; Lauren Kanapka, MSc; Craig Kollman, PhD; Roy Beck, MD, PhD; WISDM Operations committee members: Richard Pratley, MD; Michael Rickels, MD, MPH; Naomi Chaytor, PhD; D. Steven Fox, MD; Kellee M. Miller, PhD; Data and Safety Monitoring Board: Mark Espeland, PhD, FASA (chair); Guillermo Umpierrez, MD, CDE; Mary Korytkowski, MD; Matthew Gilbert, DO.

Meeting Presentation: The trial results were presented at the American Diabetes Association meeting in San Francisco, California, on June 9, 2019, and at the European Association for the Study of Diabetes meeting in Barcelona, Spain, on September 17, 2019.

Data Sharing Statement: See Supplement 3.

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