Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections the gold randomized clinical trial

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IMPORTANCE The majority of individuals with type 1 diabetes do not meet recommended glycemic targets. OBJECTIVE To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections. DESIGN, SETTING, AND PARTICIPANTS Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5%(58 mmol/mol) treated with multiple daily insulin injections. INTERVENTIONS Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks. MAIN OUTCOMES AND MEASURES Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied. RESULTS Among 161 randomized participants, mean age was 43.7 years, 45.3%were women, and mean HbA1c was 8.6%(70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92%(63 mmol/mol) during continuous glucose monitoring use and 8.35%(68 mmol/mol) during conventional treatment (mean difference, -0.43%[95%CI, -0.57%to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia. CONCLUSIONS AND RELEVANCE Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Furthe.


  • Marcus Lind
  • William Polonsky
  • Irl B Hirsch
  • Tim Heise
  • Jan Bolinder
  • Sofia Dahlqvist
  • Erik Schwarz
  • Arndis Finna Ólafsdóttir
  • Anders Frid
  • Hans Wedel
  • Elsa Ahlén
  • Thomas Nyström
  • Jarl Hellman
Enheter & grupper
Externa organisationer
  • Göteborgs universitet
  • University of Washington
  • Karolinska University Hospital
  • Karolinska Institute
  • Örebro University
  • Skåne University Hospital
  • Södersjukhuset
  • Uppsala universitet
  • NU Hospital Group
  • PROFIL Institut für Stoffwechselforschung GmbH
  • University of California, San Diego

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Endokrinologi och diabetes
Sidor (från-till)379-387
Antal sidor9
TidskriftJAMA: The Journal of the American Medical Association
Utgåva nummer4
StatusPublished - 2017 jan 24
Peer review utfördJa