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Original Investigation
January NaN, 2017

Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin InjectionsThe DIAMOND Randomized Clinical Trial

Author Affiliations
  • 1Jaeb Center for Health Research, Tampa, Florida
  • 2Oregon Health & Science University, Portland
  • 3Park Nicollet Institute, International Diabetes Center, St Louis Park, Minnesota
  • 4Diabetes & Glandular Disease Clinic, San Antonio, Texas
  • 5Division of Endocrinology, Henry Ford Medical Center, Detroit, Michigan
  • 6Washington University in St Louis, St Louis, Missouri
  • 7Behavioral Diabetes Institute, San Diego, California
  • 8Joslin Diabetes Center, Boston, Massachusetts
  • 9Dexcom Inc, San Diego, California
JAMA. 2017;317(4):371-378. doi:10.1001/jama.2016.19975
Key Points

Question  For adults with type 1 diabetes who are using multiple daily insulin injections, does continuous glucose monitoring improve hemoglobin A1c (HbA1c) levels compared with self-monitored blood glucose management?

Findings  In a randomized clinical trial of 158 adults with type 1 diabetes, there was a significantly greater decrease in HbA1c level during 24 weeks with continuous glucose monitoring vs usual care (–1.0% vs –0.4%).

Meaning  Continuous glucose monitoring resulted in better glycemic control compared with usual care, but further research is needed to assess clinical outcomes, as well as effectiveness, in a typical clinical population.

Abstract

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 A1c (HbA1c) 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 HbA1c 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 HbA1c 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 HbA1c 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 < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was –0.6% (95% CI, –0.8% to –0.3%; P < .001). Median duration of hypoglycemia at less than <70 mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (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 HbA1c 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

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