title: 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.
abstract: The majority of individuals with type 1 diabetes do not meet recommended glycemic targets.
  
  
  
  To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied.
  
  
  
  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, 6 met 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.
  
  
  
  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. Further research is needed to assess clinical outcomes and longer-term adverse effects.
  
  
  
  clinicaltrials.gov Identifier: NCT02092051.
authors.affiliation: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden2Department of Medicine, NU Hospital Group, Uddevalla, Sweden.
authors.forename: Marcus
authors.initials: M
authors.lastname: Lind
authors.affiliation: University of California, San Diego, La Jolla.
authors.forename: William
authors.initials: W
authors.lastname: Polonsky
authors.affiliation: University of Washington, School of Medicine, Seattle.
authors.forename: Irl B
authors.initials: IB
authors.lastname: Hirsch
authors.affiliation: Profil, Neuss, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Heise
authors.affiliation: Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Bolinder
authors.affiliation: Department of Medicine, NU Hospital Group, Uddevalla, Sweden.
authors.forename: Sofia
authors.initials: S
authors.lastname: Dahlqvist
authors.affiliation: Department of Internal Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Schwarz
authors.affiliation: Department of Medicine, NU Hospital Group, Uddevalla, Sweden.
authors.forename: Arndís Finna
authors.initials: AF
authors.lastname: Ólafsdóttir
authors.affiliation: Division of Endocrinology, Department of Clinical Sciences, Skåne University Hospital, Malmö9Lund University, Lund, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Frid
authors.affiliation: Health Metrics Sahlgrenska Academy at University of Gothenburg, Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Wedel
authors.affiliation: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden2Department of Medicine, NU Hospital Group, Uddevalla, Sweden.
authors.forename: Elsa
authors.initials: E
authors.lastname: Ahlén
authors.affiliation: Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Thomas
authors.initials: T
authors.lastname: Nyström
authors.affiliation: Department of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.
authors.forename: Jarl
authors.initials: J
authors.lastname: Hellman
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000523:psychology; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D017060:Patient Satisfaction; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin