Article Text

Download PDFPDF

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study
  1. Vikkie A Mustad1,
  2. Refaat A Hegazi1,2,
  3. Deborah S Hustead1,
  4. Erwin S Budiman3,
  5. Ricardo Rueda4,
  6. Kevin Maki5,6,
  7. Margaret Powers7,
  8. Jeffrey I Mechanick8,
  9. Richard M Bergenstal7,
  10. Osama Hamdy9
  1. 1Research and Development Department, Abbott Nutrition, Columbus, Ohio, USA
  2. 2Adjunct Associate Professor, Faculty of Medicine, Mansoura University, Mansoura, Egypt
  3. 3Research and Development Department, Abbott Diabetes Care, Alameda, California, USA
  4. 4Research and Development Department, Abbott Nutrition, Granada, Spain
  5. 5President and Chief Scientist, MB Clinical Research, Boca Raton, Florida, USA
  6. 6Indiana University School of Public Health, Bloomington, Indiana, USA
  7. 7International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA
  8. 8Professor of Medicine and Medical Director, Kravis Center for Cardiovascular Health at Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York, USA
  9. 9Obesity Clinical Program, Director of Inpatient Diabetes Program, Joslin Diabetes Center, Boston, Massachusetts, USA
  1. Correspondence to Dr Refaat A Hegazi; Refaat.Hegazi{at}abbott.com

Abstract

Introduction This pilot study evaluated the impact of a diabetes-specific nutritional shake (DSNS) used twice daily by people with type 2 diabetes (T2D) on glycemic response assessed by continuous glucose monitoring (CGM).

Research design and methods Adults (n=81) with T2D managed by oral medications were studied in a randomized, open-label, three-group parallel study design. The study was conducted in two phases over 14 days: Baseline (days 1–6), during which study participants consumed their habitual self-selected diets (SSD), followed by the Intervention (days 7–14), during which participants were randomized as follows: (1) SSD group received no study product (n=32); (2) DSNS breakfast/afternoon snack (Bkfst/AS) group consumed one DSNS as a breakfast meal replacement and a second to replace their mid-afternoon snack (n=24); (3) DSNS breakfast/prebed snack (Bkfst/PBS) group consumed one DSNS as a breakfast meal replacement and added a second as a prebed snack (n=25). Glucose was assessed by CGM throughout the study. Additionally, participants were asked about snacking behaviors, cravings, and other questions related to the use of DSNS as meal replacements and snacks.

Results All groups reduced their postprandial glycemic response (positive area under the curve (pAUC, mg/min*dL−1)) and adjusted peak value (mg/dL) when compared with the baseline phase. Participants consuming DSNS in place of their usual breakfast showed greater reductions in pAUC compared with the SSD group (p=0.008) for the DSNS Bkfst/AS group with a trend (p=0.069) for the DSNS Bkfst/PBS group. Adjusted peak value showed greater reductions in both DSNS groups as compared with the SSD group (p=0.002 for DSNS Bkfst/AS and p=0.010 for DSNS Bkfst/PBS). Nocturnal glucose variability was significantly decreased during the intervention phase compared with baseline phase in the DSNS Bkfst/AS group (p=0.020), with no significant differences between groups. After intervention, the DSNS Bkfst/AS group had a significantly lower percentage of participants (17%) reporting cravings for starchy meals/sides compared with before the study (33%) (p=0.046). This group also reported a significant increase in confidence in choosing foods to control their diabetes (from 58.3% to 91.7%, preintervention vs postintervention, respectively, p=0.005).

Conclusions Use of DSNS to replace breakfast and as an afternoon snack improves both glycemic control and behavioral factors related to dietary management of diabetes.

Trail registration number NCT04230889.

  • type 2 diabetes
  • continuous glucose monitoring
  • self-management
  • nutrition intervention
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors VAM, RAH, DSH, ESB, and RR conceptualized the study and played key roles in the data analysis, interpretation, writing and editing. KM, MP, JIM, RMB and OH reviewed and edited the manuscript.

  • Funding This study was sponsored by Abbott Nutrition.

  • Disclaimer The lead author (VAM) affirms the manuscript is an honest, accurate and transparent account of the study and no important aspect has been omitted.

  • Competing interests VAM, RAH, DSH, ESB, and RR are Abbott employees and stockholders. KM and MP received research support for this study from Abbott Nutrition. JIM has consulted for Abbott Nutrition. RMB has received research support, consulted, or has been on the scientific advisory board for Abbott Nutrition, Abbott Diabetes Care, DexCom, Hygieia, Johnson & Johnson, Lilly, Medtronic, Novo Nordisk, Onduo, Roche, Sanofi, Senseonics and United Healthcare. His technology research is funded in part by NIH/NIDDK. RMB’s employer, non-profit HealthPartners Institute, contracts for his services and no personal income goes to RMB. OH received research support for this study from Abbott Nutrition and has consulted for Abbott Nutrition and Abbott Diabetes Care.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the Institutional Review Board of Copernicus Group IRB (IRB Tracking: ABN1-16-657) and conducted in accordance with the principles described in the Declaration of Helsinki.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.