Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections

Autor: Andrew J. Ahmann, Elena Toschi, Janet B. McGill, David Price, Tonya D Riddlesworth, Stacie Haller, William H. Polonsky, Davida F. Kruger, Howard Wolpert, Roy W. Beck, Katrina J. Ruedy, Craig Kollman, Richard M. Bergenstal
Rok vydání: 2017
Předmět:
Zdroj: JAMA. 317:371
ISSN: 0098-7484
DOI: 10.1001/jama.2016.19975
Popis: Importance Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. Objective To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. Design, Setting, and Participants Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A 1c (HbA 1c ) levels of 7.5% to 9.9%. Interventions Random assignment 2:1 to CGM (n = 105) or usual care (control group; n = 53). Main Outcomes and Measures Primary outcome measure was the difference in change in central-laboratory–measured HbA 1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12 and 24 weeks. Results Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44% women; mean baseline HbA 1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA 1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P 1c level from baseline was –0.6% (95% CI, –0.8% to –0.3%; P P = .002). Severe hypoglycemia events occurred in 2 participants in each group. Conclusions and Relevance Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA 1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects. Trial Registration clinicaltrials.gov Identifier:NCT02282397
Databáze: OpenAIRE