Aug 21 2017
DexCom, Inc., announced today the publication of a new study that shows people with Type 2 diabetes on a multiple daily injection (MDI) insulin therapy benefit from the use of continuous glucose monitoring (CGM). Participants in the study achieved significant A1C reduction and spent more time in range, regardless of age, education or math ability.
The findings are the result of the DIaMonD study (Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes), which assessed the impact of CGM on glycemic control in individuals with Type 2 diabetes on MDI insulin therapy. Results from a parallel arm of the study using participants with Type 1 diabetes were published in January 2017.
"This study represents a significant step forward for the diabetes community," said Roy Beck, MD, lead study investigator from the Jaeb Center for Health Research. "The results allow us to confidently tell people with Type 2 diabetes using insulin they can use CGM to take control of their disease and make better treatment decisions."
Published today in the Annals of Internal Medicine, the study showed:
- After 24 weeks participants with Type 2 diabetes using CGM while on MDI insulin therapy averaged a 0.8 percent A1C reduction compared to baseline (changes in A1C are measured as absolute percent changes; in this case, a reduction from an average baseline A1C of 8.5% to 7.7%)
- A subset of this group with an A1C of 9.0 percent or higher saw an average 1.4 percent reduction from baseline at week 24
- The CGM group also decreased time in hyperglycemia and increased time spent in the target range compared to the control group (use of only a standard meter to test glucose)
- The CGM group increased time in range by 1.3 hours compared to baseline, and 0.6 hours compared to the control group
- The A1C reductions occurred with minimal changes in insulin dosages or regimen, and nearly no additions of non-insulin diabetes medications
The study also dispels the perception that people with diabetes on an MDI regimen would find CGM too complicated or a hassle to use. Subjects in the study demonstrated significant A1C reductions regardless of age, education level or math ability and showed high rates of adherence - 93 percent of participants were still using CGM six or more days per week at the end of the study. Participants also reported a high level of satisfaction and a relatively low level of perceived hassles.
"We have been successful in driving innovation and adoption of CGM in the Type 1 diabetes community, but this arm of the DIaMonD study is one of the first to examine how well CGM works for people with Type 2 diabetes on MDI," said Kevin Sayer, president and CEO of Dexcom. "We are pleased to see a significant A1C reduction in this study, showing that the millions of people globally with Type 2 diabetes on MDI insulin therapy can benefit from CGM use."
The DIaMonD Type 2 diabetes study was conducted between October 2014 and May 2016 at 25 endocrinology practices in North America using 158 adult subjects with Type 2 diabetes on MDI insulin therapy. Participants ranged in age from 35 to 79 years, with a mean age of 60 years. The protocol was designed to reflect common clinical practice, with follow-up visits at months one, three and six. The study used the Dexcom G4® PLATINUM CGM System, which uses the same software as the current Dexcom G5® Mobile CGM System.
The prevalence of diabetes continues to rise in the U.S. and around the world. According to the 2017 National Diabetes Statistics Report by the Centers for Disease Control and Prevention (CDC), more than 30 million people in the U.S. have diabetes, with 23.8 percent of that population undiagnosed. Among children and adolescents age 10 to 19, there were an estimated 5,300 newly diagnosed cases of Type 2 diabetes in the U.S. annually from 2011 to 2012. With diabetes being the seventh leading cause of death in 2015, health care costs related to the disease are also on the rise. Average medical expenditures among people with diabetes are more than twice those of people without the disease.