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Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 DiabetesA Randomized Clinical Trial

Educational Objective
To learn about continuous glucose monitoring for adolescents and young adults with type 1 diabetes.
1 Credit CME
Key Points

Question  Is continuous glucose monitoring effective in improving glycemic control compared with standard blood glucose monitoring in adolescents and young adults with type 1 diabetes?

Findings  In this randomized clinical trial that included 153 participants aged 14 to 24 years with type 1 diabetes, treatment with continuous glucose monitoring compared with standard blood glucose monitoring resulted in a significantly lower hemoglobin A1c level after 26 weeks (adjusted difference, 0.37%).

Meaning  Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks.

Abstract

Importance  Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.

Objective  To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.

Design, Setting, and Participants  Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.

Interventions  Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).

Main Outcomes and Measures  The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.

Results  Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, −0.37% [95% CI, −0.66% to −0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).

Conclusions and Relevance  Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.

Trial Registration  ClinicalTrials.gov Identifier: NCT03263494

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Article Information

Corresponding Author: Kellee M. Miller, PhD, Jaeb Center for Health Research, 15310 Amberly Dr, #350, Tampa, FL 33647 (kmiller@jaeb.org).

Accepted for Publication: April 11, 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: Laffel, Kanapka, Beck, Bergamo, Clements, DeSalvo, Goland, Hood, Messer, Monzavi, Mouse, Sherr, Simmons, Willi, Miller.

Acquisition, analysis, or interpretation of data: Laffel, Kanapka, Bergamo, Clements, Criego, DeSalvo, Goland, Hood, Liljenquist, Messer, Monzavi, Mouse, Prahalad, Sherr, Simmons, Wadwa, Weinstock, Willi, Miller.

Drafting of the manuscript: Laffel, Kanapka, DeSalvo, Miller.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Laffel, Kanapka, DeSalvo, Hood.

Obtained funding: Laffel, DeSalvo, Miller.

Administrative, technical, or material support: Laffel, Beck, Goland, Hood, Messer, Mouse, Simmons, Willi, Miller.

Supervision: Laffel, Beck, Bergamo, DeSalvo, Goland, Hood, Liljenquist, Monzavi, Mouse, Prahalad, Weinstock, Willi.

Other - primary investigator at clinical site: Criego.

Other - participated in planning and progress meetings in person and via web conference: Clements.

Other - trial coordination and data monitoring: Mouse.

Other - patient recruitment, enrollment, follow-up, procedures, and protocol implementations: Monzavi.

Conflict of Interest Disclosures: Dr Laffel reported receiving personal fees from NovoNordisk, Eli Lilly, Sanofi, Insulet, Convatec, Dexcom, Medtronic, Roche, Boehringer Ingelheim, and Insulogic outside the submitted work. Dr Beck reported receiving grants and nonfinancial support from Dexcom; consulting fees paid to his institution from Bigfoot BioMedical, Insulet, and Eli Lilly; grants and consulting fees paid to his institution from Tandem Diabetes Care; and nonfinancial support from Roche and Ascencia outside the submitted work. Dr Clements reported receiving personal fees from Glooko, Medtronic, and Eli Lilly outside the submitted work. Dr Criego reported receiving grants from DexCom, Medtronic, Insulet, Juvenile Diabetes Research Foundation, the National Institutes of Health, and Abbott and study supplies from Eli Lilly outside the submitted work. Dr DeSalvo reported receiving personal fees and nonfinancial support from Dexcom. Dr Hood reported receiving grants from Dexcom and personal fees from Lifescan Diabetes Institute outside the submitted work. Dr Liljenquist reported receiving grants and nonfinancial support from Abbott and Medtronic outside the submitted work. Dr Messer reported receiving personal fees from Tandem Diabetes Care, Dexcom, Capillary Biomedical, and Clinical Sensors outside the submitted work. Dr Sherr reported receiving grants and personal fees from Medtronic Diabetes and Insulet and personal fees from Sanofi, Eli Lilly, and Bigfoot Biomedical outside the submitted work. Dr Wadwa reported receiving grants, personal fees, and nonfinancial support from Eli Lilly and Dexcom; grants from Bigfoot Biomedical; personal fees from Medtronic; and grants and nonfinancial support from MannKind Corporation, Nordisk, and Tandem Diabetes Care outside the submitted work. Dr Weinstock reported receiving grants from Insulet Corporation, Tolerion Inc, Eli Lilly, Medtronic, Diasome Pharmaceuticals, Boehringer Ingelheim, Oramed Ltd, and Mylan GmbH and personal fees from Insulogic outside the submitted work. Dr Willi reported serving on a data safety monitoring board for the National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health and serving on an advisory panel for Roche Diagnostics outside the submitted work. No other disclosures were reported.

Funding/Support: This study was funded by a grant provided by the Leona M. and Harry B. Helmsley Charitable Trust given to the Jaeb Center for Health Research. Dexcom Inc provided nonfinancial support by providing continuous glucose monitoring devices and sensors for the study.

Role of the Funder/Sponsor: There was no involvement from the Leona M. and Harry B. Helmsley Charitable Trust or Dexcom in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. 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 journal was not required. There was no approval by the Leona M. and Harry B. Helmsley Charitable Trust or Dexcom required or obtained for manuscript submission.

Meeting Presentation: The trial results were presented at the American Diabetes Association meeting, San Francisco, CA, on June 10, 2019, and the International Society for Pediatric and Adolescent Diabetes meeting, Boston, MA, on October 31, 2019.

Data Sharing Statement: See Supplement 3.

CITY Study Group: A listing of the CGM Intervention in Teens and Young Adults with Type 1 Diabetes (T1D) (CITY) sites with participating principal investigators (PI), co-investigators (I), primary coordinator (PC), and coordinators (C) is included below: Joslin diabetes Center, Harvard University, Boston, MA: Lori Laffel, MD, MPH (PI); Dayna McGill, MD (I); Emily Freiner, MSN, RN, NP-C (PC); Alan Schultz, MSN, RN, CPNP (C); Hannah Desrochers, MSN, RN, CPNP (C); Nisha Naik, BA (C); University of Colorado/Denver, Barbara Davis Center for Diabetes Aurora, CO: Paul Wadwa, MD (PI); Laurel Messer, RN, MPH, CDE, PhD (I); Todd Alonso, MD (I); Shideh Majidi, MD (I); Emily Simmons, BA (PC); Isabel Weber, MS, RD (C); Michelle Clay, BSN (C); Alex Coakly, BS (C); Tyler Reznick-Lipina, BS (C); Stanford University, Stanford, CA: Priya Prahalad, MD, PhD (PI); Darrel Wilson, MD (I); Bruce Buckingham, MD (I); Ryan Kingman, BS (PC); Marissa Ann Town, RN, BSN, CDE (C); International Diabetes Center/Park Nicollet/HealthPartners Institute Minneapolis, MN: Amy Criego, MD, MS (PI); Shannon Beasley, NP (I); Sean Dunnigan, RN, BSN (PC); Kathleen McCann, RN, BA (C); Yale University School of Medicine, New Haven, CT: Jennifer Sherr, MD, PhD (PI); Kate Weyman, MSN, APRN, FNP-C, CDE (I); Eileen Tichy, MMSc, PA-C, RD, CDE (I); Katie Gibbons, MD (I); Amy Steffen, RN, BSN (PC); Jennifer Finnegan (C); Naomi Berrie Diabetes Center, Columbia University New York City: NY Robin Goland, MD (PI); Kristen Williams, MD (I); Sarah Pollak, RN (PC); Eberechi Cecilia Uche, BA (C); Courtney Sahn, RD (C); Analia Alvarez, RN (C); Courtney Melrose, RDN (C); Elizabeth Robinson, BA (C); University of North Carolina Diabetes Care Center Chapel Hill, NC Katherine Bergamo, BSN, MSN, FNP-C (PI); John Buse, MD, PhD (I); Jean Dostou, MD, FACE (I); Marian Sue Kirkman, MD (I); Laura Young, MD, PhD (I); Alexander Kass, BSN, RN, CDE (PC); Julie Uehling, BA, MS, CCRP (C); SUNY Upstate Medical University Syracuse, NY Ruth Weinstock, MD, PhD (PI); Angela Mojica, MD (I); Suzan Bzdick, RN, CDE (PC); Patricia Conboy (C); Rocky Mountain Diabetes & Osteoporosis Center, Idaho Fall, ID David Liljenquist, MD (PI); Carl Vance, MD (I); Mark Sulik, PharmD, CCRP (I); William Hardee, BS, CRC (PC); Christine Duval, BS, CCRC (C); Children’s Hospital Los Angeles, Los Angeles, CA: Roshanak Monzavi, MD (PI); Jennifer Raymond, MD, MCR (I); Daniel Brimberry, PhD (PC); Debra Miller, RN, BSN, CDE (C); Daniel Bisno, BA (C); Vanderbilt University Medical Center, Nashville, TN: Jill Simmons, MD (PI); Jennifer Kelley, MD (I); George Williams, RN, CDE (PC); Children’s Hospital of Philadelphia, Philadelphia, PA: Steven Willi, MD (PI); Pantea Minnock, RN, MSN, CPNP (I); Diana Olivos, MS (PC); Fiona Stuart, BSN, RN (C); Brian Grant, BSN, RN, CDE (C); Jennifer Smith, MPH (C); Baylor College of Medicine, Houston, TX: Daniel J. DeSalvo, MD (PI); Sarah K. Lyons, MD (I); Mary-Kylie DeLaO, MSN, RN, CDE (PC); Children’s Mercy Hospital, Kansas City, MO: Mark Clements, MD, PhD (PI); Wayne Moore, MD, PhD (I); Ryan McDonough, DO (I); Sarah Tsai, MD, FRCPC (I); Terri Lutjen, MS, RN, CPNP, CCRC (I); Jennifer James, BS, CCRC (PC); Heather Harding, RN (C); Stephen Orlich, RN, ACRP-CP (C); Jaeb Center for Health Research Tampa, FL: Kellee M. Miller, PhD; Thomas Mouse, BS, 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; CITY Operations Committee Members: Mark Clements, MD, PhD, Daniel DeSalvo, MD, Korey Hood, PhD, Lauren Kanapka, MSc, Lori Laffel, MD, MPH, Laurel Messer, PhD, RN, MPH, CDE, Kellee Miller, PhD, Thomas Mouse, BS, Jennifer Sherr, MD, PhD; Ruth Weinstock, MD, PhD; Data and Safety Monitoring Board (DSMB): Diane Wherrett, MD, FRCPC; Randi Streisand, PhD; Leslie Plotnick, MD.

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