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Sustained Intensive Treatment and Long-term Effects on HbA(1c) Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI
Univ Gothenburg, Sweden; NU Hosp Grp, Sweden.
Univ Gothenburg, Sweden; NU Hosp Grp, Sweden.
Univ Washington, WA USA.
Karolinska Univ, Sweden.
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2021 (English)In: Diabetes Care, ISSN 0149-5992, E-ISSN 1935-5548, Vol. 44, no 1, p. 141-149Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE Continuous glucose monitoring (CGM) reduces HbA(1c) and time spent in hypoglycemia in people with type 1 diabetes (T1D) treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns, and overall well-being over longer periods of time. RESEARCH DESIGN AND METHODS The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial (n = 141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months. RESULTS The primary end point of the change in HbA(1c) over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA(1c) of 0.35% (95% CI 0.19-0.50, P < 0.001). Time spent in hypoglycemia <3.0 mmol/L (54 mg/dL) and <4.0 mmol/L (72 mg/dL) decreased from 2.1% to 0.6% (P < 0.001) and from 5.4% to 2.9% (P < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index, P = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire, P < 0.001), and hypoglycemic confidence (P < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry, P = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale, P = 0.06). From randomization and screening in GOLD, HbA(1c) was lowered by 0.45% (P < 0.001) and 0.68% (P < 0.001) after 2.3 and 2.5 years, respectively. CONCLUSIONS The SILVER study supports beneficial long-term effects from CGM on HbA(1c), hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.

Place, publisher, year, edition, pages
Arlington, VA, United States: American Diabetes Association , 2021. Vol. 44, no 1, p. 141-149
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:liu:diva-172307DOI: 10.2337/dc20-1468ISI: 000600653200028PubMedID: 33199470OAI: oai:DiVA.org:liu-172307DiVA, id: diva2:1515014
Note

Funding Agencies|Swedish State (ALF grant); Dexcom Inc.

Available from: 2021-01-07 Created: 2021-01-07 Last updated: 2021-01-11Bibliographically approved

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Wijkman, Magnus
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Division of Diagnostics and Specialist MedicineFaculty of Medicine and Health SciencesDepartment of Internal Medicine in Norrköping
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