Roy W. Beck, MD, PhD; Tonya D. Riddlesworth, PhD; Katrina Ruedy, MSPH; Andrew Ahmann, MD; Stacie Haller, RD, LD, CDE; Davida Kruger, MSN, APN-BC; Janet B. McGill, MD; William Polonsky, PhD; David Price, MD; Stephen Aronoff, MD; Ronnie Aronson, MD; Elena Toschi, MD; Craig Kollman, PhD; Richard Bergenstal, MD; for the DIAMOND Study Group *
Financial Support: By Dexcom.
Disclosures: Dr. Beck reports grants from Dexcom during the conduct of the study and other support from Dexcom and Abbott Diabetes Care outside the submitted work. Ms. Ruedy reports grants from Dexcom during the conduct of the study and other fees from Dexcom and Abbott Diabetes Care outside the submitted work. Dr. Ahmann reports grants and personal fees from Dexcom during the conduct of the study; grants from Novo Nordisk, Sanofi, Lexicon, and Medtronic outside the submitted work; and personal fees from Novo Nordisk, Sanofi, Eli Lilly, and Janssen outside the submitted work. Ms. Kruger reports grants from Henry Ford Health System during the conduct of the study; grants from Novo Nordisk, Eli Lilly, Dexcom, and Abbott Diabetes Care outside the submitted work; personal fees from Novo Nordisk, Janssen, Eli Lilly, Boehringer Ingelheim, Sanofi, Dexcom, Abbott Diabetes Care, Intarsia, and AstraZeneca outside the submitted work; and holding Dexcom stock. Dr. McGill reports personal fees from Boehringer Ingelheim, Dexcom, Dynavax, Janssen, Intarcia, Merck, Novo Nordisk, and Valeritas and grants from Dexcom, AstraZeneca/Bristol-Myers Squibb, Novartis, and Lexicon outside the submitted work. Dr. Polonsky reports personal fees from Dexcom during the conduct of the study and from Dexcom and Abbott Diabetes Care outside the submitted work. Dr. Price reports being a Dexcom employee and a shareholder of Dexcom stock. Dr. Aronson reports research support from Merck, Boehringer Ingelheim, Regeneron, Abbott Diabetes Care, Quintiles, ICON, GlaxoSmithKline, Medpace, Novo Nordisk, Janssen, Sanofi, Bristol-Myers Squibb, AstraZeneca, Becton Dickinson, Eli Lilly, Amgen, and Takeda and personal fees from Novo Nordisk, Janssen, Sanofi, AstraZeneca, Becton Dickinson, Eli Lilly, and Amgen outside the submitted work. Dr. Kollman reports grants from Dexcom during the conduct of the study. Dr. Bergenstal reports grants and other fees from Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Bristol-Myers Squibb/AstraZeneca, Calibra Medical, Eli Lilly, Hygieia, Johnson & Johnson, Medtronic, Novo Nordisk, Roche, Sanofi, Takeda, and Dexcom during the conduct of the study. Dr. Bergenstal is employed by HealthPartners Institute/Park Nicollet Health Services and has contracts with the listed companies for his services as a research investigator or consultant; no personal income from any of these services goes to Dr. Bergenstal. Dr. Bergenstal also reports holding stock in Merck. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2855.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol and statistical code: See the Supplement. Data set: Not available.
Corresponding Author: Roy W. Beck, MD, PhD, Jaeb Center for Health Research, 15310 Amberly Drive, #350, Tampa, FL 33647; e-mail, rbeck@jaeb.org.
Current Author Addresses: Drs. Beck, Riddlesworth, and Kollman and Ms. Ruedy: Jaeb Center for Health Research, 15310 Amberly Drive, #350, Tampa, FL 33647.
Dr. Ahmann: Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, 3147 SW Sam Jackson Park Road, Portland, OR 97239.
Ms. Haller: Diabetes & Glandular Disease Clinic, 5107 Medical Drive, San Antonio, TX 78229.
Ms. Kruger: Henry Ford Medical Center Division of Endocrinology, 3031 West Grand Boulevard, Suite 800, Detroit, MI 48202.
Dr. McGill: Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8127, St. Louis, MO 63110.
Dr. Polonsky: Behavioral Diabetes Institute, 5405 Oberlin Drive, Suite 100, San Diego, CA 92121.
Dr. Price: Dexcom, Inc., 6340 Sequence Drive, San Diego, CA 92121.
Dr. Aronoff: Research Institute of Dallas, 10260 North Central Expressway, Suite 100N, Dallas, TX 75231.
Dr. Aronson: LMC Diabetes & Endocrinology, 1929 Bayview Avenue #106, Toronto, Ontario M4G 3E8, Canada.
Dr. Toschi: Joslin Diabetes Center, One Joslin Place, Boston, MA 02215.
Dr. Bergenstal: Park Nicollet Institute, International Diabetes Center, 3800 Park Nicollet Boulevard, St. Louis Park, MN 55416.
Author Contributions: Conception and design: R.W. Beck, K. Ruedy, A. Ahmann, W. Polonsky, D. Price, E. Toschi, C. Kollman, R. Bergenstal.
Analysis and interpretation of the data: R.W. Beck, T.D. Riddlesworth, J.B. McGill, W. Polonsky, D. Price, R. Aronson, E. Toschi, C. Kollman, R. Bergenstal.
Drafting of the article: R.W. Beck, T.D. Riddlesworth, A. Ahmann, S. Haller, D. Price, R. Bergenstal.
Critical revision of the article for important intellectual content: T.D. Riddlesworth, K. Ruedy, S. Haller, D. Kruger, J.B. McGill, W. Polonsky, D. Price, R. Aronson, E. Toschi, C. Kollman, R. Bergenstal.
Final approval of the article: R.W. Beck, T.D. Riddlesworth, K. Ruedy, A. Ahmann, S. Haller, D. Kruger, J.B. McGill, W. Polonsky, D. Price, S. Aronoff, R. Aronson, E. Toschi, C. Kollman, R. Bergenstal.
Provision of study materials or patients: K. Ruedy, A. Ahmann, J.B. McGill, S. Aronoff, R. Aronson, E. Toschi, R. Bergenstal.
Statistical expertise: R.W. Beck, T.D. Riddlesworth, C. Kollman.
Obtaining of funding: D. Price.
Administrative, technical, or logistic support: R.W. Beck, K. Ruedy.
Collection and assembly of data: T.D. Riddlesworth, K. Ruedy, D. Kruger, J.B. McGill, S. Aronoff, R. Aronson, E. Toschi, R. Bergenstal.
Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin.
To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin.
Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397)
25 endocrinology practices in North America.
158 adults who had had type 2 diabetes for a median of 17 years (interquartile range, 11 to 23 years). Participants were aged 35 to 79 years (mean, 60 years [SD, 10]), were receiving multiple daily injections of insulin, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%).
Random assignment to CGM (n = 79) or usual care (control group, n = 79).
The primary outcome was HbA1c reduction at 24 weeks.
Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, −0.3% [95% CI, −0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week.
6-month follow-up.
A high percentage of adults who received multiple daily insulin injections for type 2 diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type 2 diabetes currently use CGM, these results support an additional management method that may benefit these patients.
Dexcom.
Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. [Epub ahead of print 22 August 2017]167:365–374. doi: 10.7326/M16-2855
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© 2019
Published: Ann Intern Med. 2017;167(6):365-374.
DOI: 10.7326/M16-2855
Published at www.annals.org on 22 August 2017
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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