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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

Artikel i vetenskaplig tidskrift
Författare Marcus Lind
W. Polonsky
I. B. Hirsch
T. Heise
J. Bolinder
S. Dahlqvist
E. Schwarz
A. F. Olafsdottir
A. Frid
Hans Wedel
Elsa Ahlén
T. Nystrom
J. Hellman
Publicerad i Jama-Journal of the American Medical Association
Volym 317
Nummer/häfte 4
Sidor 379-387
ISSN 0098-7484
Publiceringsår 2017
Publicerad vid Institutionen för medicin, avdelningen för molekylär och klinisk medicin
Institutionen för medicin, avdelningen för samhällsmedicin och folkhälsa, enheten för hälsometri
Sidor 379-387
Språk en
Länkar dx.doi.org/10.1001/jama.2016.19976
Ämnesord blood-glucose, treatment satisfaction, severe hypoglycemia, swedish, version, pump therapy, association, reduction, frequency, General & Internal Medicine, lonsky wh, 1995, diabetes care, v18, p754
Ämneskategorier Invärtesmedicin

Sammanfattning

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 A(1c) (HbA(1c)) 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 HbA(1c) 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 HbA(1c) was 8.6%(70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA(1c) 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. 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 HbA(1c). Further research is needed to assess clinical outcomes and longer-term adverse effects.

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