A Randomized Clinical Trial of the Effect of Continuous Glucose Monitoring on Nocturnal Hypoglycemia, Daytime Hypoglycemia, Glycemic Variability, and Hypoglycemia Confidence in Persons with Type 1 Diabetes Treated with Multiple Daily Insulin Injections (GOLD-3)Show others and affiliations
2018 (English)In: Diabetes Technology & Therapeutics, ISSN 1520-9156, E-ISSN 1557-8593, Vol. 20, no 4, p. 274-284Article in journal (Refereed) Published
Abstract [en]
Background: To evaluate the effects of continuous glucose monitoring (CGM) on nocturnal and daytime hypoglycemia in persons with type 1 diabetes treated with multiple daily insulin injections (MDI); we also evaluated factors related to differences in hypoglycemia confidence in this population. Methods: Evaluations were performed from the GOLD randomized trial, an open-label multicenter crossover randomized clinical trial (n=161) over 69 weeks comparing CGM to self-measurement of blood glucose (SMBG) in persons with type 1 diabetes treated with MDI. Masked CGM and the hypoglycemia confidence questionnaire were used for evaluations. Results: Time with nocturnal hypoglycemia, glucose levels amp;lt;70mg/dL was reduced by 48% (10.2 vs. 19.6min each night, Pamp;lt;0.001) and glucose levels amp;lt;54mg/dL by 65%. (3.1 vs. 8.9min, Pamp;lt;0.001). For the corresponding glucose cutoffs, daytime hypoglycemia was reduced by 40% (29 vs. 49min, Pamp;lt;0.001) and 54% (8 vs. 18min., Pamp;lt;0.001), respectively. Compared with SMBG, CGM use improved hypoglycemia-related confidence in social situations (P=0.016) and confidence in more broadly avoiding serious problems due to hypoglycemia (P=0.0020). Persons also reported greater confidence in detecting and responding to decreasing blood glucose levels (thereby avoiding hypoglycemia) during CGM use (P=0.0033) and indicated greater conviction that they could more freely live their lives despite the risk of hypoglycemia (P=0.022). Conclusion: CGM reduced time in both nocturnal and daytime hypoglycemia in persons with type 1 diabetes treated with MDI and improved hypoglycemia-related confidence, especially in social situations, thus contributing to greater well-being and quality of life. Trial registration: ClinicalTrials.gov, number NCT02092051.
Place, publisher, year, edition, pages
MARY ANN LIEBERT, INC , 2018. Vol. 20, no 4, p. 274-284
Keywords [en]
Type 1 diabetes mellitus; Continuous glucose monitoring; Randomized clinical trial; Hypoglycemia; Hypoglycemia fear
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:liu:diva-147382DOI: 10.1089/dia.2017.0363ISI: 000428848900001PubMedID: 29608107OAI: oai:DiVA.org:liu-147382DiVA, id: diva2:1206992
Note
Funding Agencies|NU Hospital Group, Trollhattan and Uddevalla, Sweden; NU Hospital Group; Swedish government
2018-05-182018-05-182018-05-18