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Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1
Marcus Lind1,2, Arndís F Ólafsdóttir3,2, Irl B Hirsch4
1Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden marcus.lind@gu.se.
Insights
Continuous glucose monitoring (CGM) significantly improves long-term glycemic control and reduces hypoglycemia in type 1 diabetes (T1D). This technology also enhances treatment satisfaction and overall well-being for individuals using multiple daily insulin injections.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Diabetes Management
Background:
- Continuous glucose monitoring (CGM) is known to improve glycemic control over short periods in type 1 diabetes (T1D) patients on multiple daily insulin injections (MDI).
- However, the long-term impact of CGM on glycemic control, treatment satisfaction, diabetes distress, and well-being remains less understood.
Purpose of the Study:
- To evaluate the long-term efficacy of CGM in maintaining improved glycemic control and its effects on treatment satisfaction, diabetes distress, and well-being in T1D patients on MDI.
- To assess the sustained benefits of CGM beyond the initial study period.
Main Methods:
- The SILVER study was an extension of the GOLD trial, involving 107 participants with T1D on MDI who continued CGM for an additional year.
- Participants received support from a diabetes nurse every three months.
Main Results:
- CGM use over 1.0-1.5 years resulted in a significant decrease in HbA1c by 0.35% compared to self-monitoring.
- Time spent in hypoglycemia decreased significantly, and participants reported increased overall well-being, treatment satisfaction, and hypoglycemic confidence.
- Diabetes distress showed a trend toward decrease, while hypoglycemic fear decreased significantly.
Conclusions:
- The SILVER study demonstrates that continuous glucose monitoring provides sustained beneficial effects on HbA1c, hypoglycemia, treatment satisfaction, well-being, and confidence in individuals with T1D on MDI.
- Long-term CGM use is associated with significant improvements in key diabetes management parameters.
Objective:
Continuous glucose monitoring (CGM) reduces HbA1c 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 HbA1c over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA1c 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, HbA1c 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 HbA1c, hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.
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