Roy W Beck1, Tonya D Riddlesworth1, Katrina Ruedy1, Andrew Ahmann1, Stacie Haller1, Davida Kruger1, Janet B McGill1, William Polonsky1, David Price1, Stephen Aronoff1, Ronnie Aronson1, Elena Toschi1, Craig Kollman1, Richard Bergenstal1. 1. From Jaeb Center for Health Research, Tampa, Florida; Oregon Health & Science University, Portland, Oregon; Diabetes & Glandular Disease Clinic, San Antonio, Texas; Henry Ford Medical Center, Detroit, Michigan; Washington University in St. Louis, St. Louis, Missouri; Behavioral Diabetes Institute and Dexcom, San Diego, California; Research Institute of Dallas, Dallas, Texas; LMC Diabetes & Endocrinology, Toronto, Ontario, Canada; Joslin Diabetes Center, Boston, Massachusetts; and Park Nicollet International Diabetes Center, St. Louis Park, Minnesota.
Abstract
Background: 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. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin. Design: Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397). Setting: 25 endocrinology practices in North America. Patients: 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%). Intervention: Random assignment to CGM (n = 79) or usual care (control group, n = 79). Measurements: The primary outcome was HbA1c reduction at 24 weeks. Results:MeanHbA1c 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. Limitation: 6-month follow-up. Conclusion: 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. Primary Funding Source: Dexcom.
RCT Entities:
Background: 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. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin. Design: Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397). Setting: 25 endocrinology practices in North America. Patients: 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%). Intervention: Random assignment to CGM (n = 79) or usual care (control group, n = 79). Measurements: The primary outcome was HbA1c reduction at 24 weeks. Results: 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. Limitation: 6-month follow-up. Conclusion: 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. Primary Funding Source: Dexcom.
Authors: Roy W Beck; Crystal G Connor; Deborah M Mullen; David M Wesley; Richard M Bergenstal Journal: Diabetes Care Date: 2017-08 Impact factor: 19.112