scholarly journals Sustained Intensive treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in persons with type 1 diabetes treated with MDI

Author(s):  
Marcus Lind ◽  
Arndís F. Ólafsdóttir ◽  
Irl B. Hirsch ◽  
Jan Bolinder ◽  
Sofia Dahlqvist ◽  
...  

Objective: Continuous Glucose Monitoring (CGM) reduces HbA1c and time spent in hypoglycemia in persons with type 1 diabetes 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 <p><br> Research design and methods: The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in persons with type 1 diabetes treated with MDI. Persons 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. <br> <br> </p> <p>Results: The primary endpoint, change in HbA1c over 1.0-1.5 years CGM use compared with previous self-monitoring of blood glucose (SMBG) 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 (WHO-5, p=0.009), treatment satisfaction (DTSQ, p<0.001) and hypoglycemic confidence (p<0.001) increased, while hypoglycemic fear (HFS-Worry, p=0.016) decreased and diabetes distress tended to decrease (PAID, 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. <br> <br> Conclusions: The SILVER study supports beneficial long-term effects from CGM on HbA1c, hypoglycemia, treatment satisfaction, well-being and hypoglycemic confidence in persons with T1D managed with MDI. </p>

2020 ◽  
Author(s):  
Marcus Lind ◽  
Arndís F. Ólafsdóttir ◽  
Irl B. Hirsch ◽  
Jan Bolinder ◽  
Sofia Dahlqvist ◽  
...  

Objective: Continuous Glucose Monitoring (CGM) reduces HbA1c and time spent in hypoglycemia in persons with type 1 diabetes 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 <p><br> Research design and methods: The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in persons with type 1 diabetes treated with MDI. Persons 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. <br> <br> </p> <p>Results: The primary endpoint, change in HbA1c over 1.0-1.5 years CGM use compared with previous self-monitoring of blood glucose (SMBG) 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 (WHO-5, p=0.009), treatment satisfaction (DTSQ, p<0.001) and hypoglycemic confidence (p<0.001) increased, while hypoglycemic fear (HFS-Worry, p=0.016) decreased and diabetes distress tended to decrease (PAID, 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. <br> <br> Conclusions: The SILVER study supports beneficial long-term effects from CGM on HbA1c, hypoglycemia, treatment satisfaction, well-being and hypoglycemic confidence in persons with T1D managed with MDI. </p>


2020 ◽  
Author(s):  
Stéphane Roze ◽  
John Isitt ◽  
Jayne Smith-Palmer ◽  
Mehdi Javanbakht ◽  
Peter Lynch

<b>Objective</b> <p>A long-term health economic analysis was performed to establish the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) (Dexcom G6) versus self-monitoring of blood glucose (SMBG) alone in UK-based patients with type 1 diabetes. </p> <p><b>Methods</b></p> <p>The analysis utilized the IQVIA CORE Diabetes Model. Clinical input data were sourced from the DIAMOND trial in adults with type 1 diabetes; simulations were performed separately in the overall population of patients with baseline HbA1c ≥7.5% (58 mmol/mol); and a secondary analysis was performed in patients with baseline HbA1c ≥8.5% (69 mmol/mol). The analysis was performed from the NHS healthcare payer perspective over a lifetime time horizon. </p> <p><b>Results</b></p> <p>In the overall population, G6 RT-CGM was associated with a mean incremental gain in quality-adjusted life expectancy of 1.49 quality-adjusted life years (QALYs) versus SMBG (mean [standard deviation; SD] 11.47 [2.04] QALYs versus 9.99 [1.84] QALYs). Total mean (SD) lifetime costs were also GBP 14,234 higher with RT-CGM (GBP 102,468 [35,681] versus GBP 88,234 [39,027]) resulting in an ICER of GBP 9,558 per QALY gained. Sensitivity analyses revealed that the findings were sensitive to changes in the quality of life benefit associated with reduced fear of hypoglycemia and avoidance of fingerstick testing as well as the HbA1c benefit associated with RT-CGM use. </p> <p><b>Conclusions</b></p> <p>For UK-based type 1 diabetes patients, the G6 RT-CGM device is associated with significant improvements in clinical outcomes and, over patient lifetimes, is a cost-effective disease management option relative to SMBG, based on a willingness-to-pay threshold of GBP 20,000 per QALY gained. </p>


2020 ◽  
Author(s):  
Stéphane Roze ◽  
John Isitt ◽  
Jayne Smith-Palmer ◽  
Mehdi Javanbakht ◽  
Peter Lynch

<b>Objective</b> <p>A long-term health economic analysis was performed to establish the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) (Dexcom G6) versus self-monitoring of blood glucose (SMBG) alone in UK-based patients with type 1 diabetes. </p> <p><b>Methods</b></p> <p>The analysis utilized the IQVIA CORE Diabetes Model. Clinical input data were sourced from the DIAMOND trial in adults with type 1 diabetes; simulations were performed separately in the overall population of patients with baseline HbA1c ≥7.5% (58 mmol/mol); and a secondary analysis was performed in patients with baseline HbA1c ≥8.5% (69 mmol/mol). The analysis was performed from the NHS healthcare payer perspective over a lifetime time horizon. </p> <p><b>Results</b></p> <p>In the overall population, G6 RT-CGM was associated with a mean incremental gain in quality-adjusted life expectancy of 1.49 quality-adjusted life years (QALYs) versus SMBG (mean [standard deviation; SD] 11.47 [2.04] QALYs versus 9.99 [1.84] QALYs). Total mean (SD) lifetime costs were also GBP 14,234 higher with RT-CGM (GBP 102,468 [35,681] versus GBP 88,234 [39,027]) resulting in an ICER of GBP 9,558 per QALY gained. Sensitivity analyses revealed that the findings were sensitive to changes in the quality of life benefit associated with reduced fear of hypoglycemia and avoidance of fingerstick testing as well as the HbA1c benefit associated with RT-CGM use. </p> <p><b>Conclusions</b></p> <p>For UK-based type 1 diabetes patients, the G6 RT-CGM device is associated with significant improvements in clinical outcomes and, over patient lifetimes, is a cost-effective disease management option relative to SMBG, based on a willingness-to-pay threshold of GBP 20,000 per QALY gained. </p>


2019 ◽  
Vol 8 (3) ◽  
pp. 394 ◽  
Author(s):  
Jon-Duri Senn ◽  
Stefan Fischli ◽  
Lea Slahor ◽  
Susanne Schelbert ◽  
Christoph Henzen

Background: We aimed to assess the long-term effects of the introduction of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D). Methods: A prospective single-centre cohort study including participants with T1D and HbA1c > 7.5%. After completing a course in flexible intensified insulin treatment (FIT), participants were offered treatment change to CSII/CGM. FIT participants with HbA1c ≤ 7.5% who remained on multiple daily injections (MDI) and without CGM were monitored as a separate cohort to compare the cumulative incidence of diabetic complications. Results: The study cohort included 41 participants with T1D (21 male/20 female). The mean age (±SD) at inclusion was 24.2 ± 10.9 years, the mean follow-up was 8.9 ± 2.8 years, and the mean diabetes duration at the end of the study was 15.9 ± 10.1 years. The mean HbA1c level before the introduction of CSII was 8.8 ± 1.3% (73 ± 8 mmol/mol), and decreased significantly thereafter to 8.0 ± 1.1% (63 ± 7 mmol/mol) (p = 0.0001), and further to 7.6 ± 1.1% (59 ± 11 mmol/mol) after the initiation of CGM (p = 0.051). In the MDI group the HbA1c levels did not change significantly during a mean follow-up of 6.8 ± 3.2 years. The frequency of severe hypoglycaemia after the introduction of CSII/CGM declined significantly (from 9.7 to 2.2 per 100 patient-years, p = 0.03), and the cumulative incidence of newly diagnosed diabetic microvascular complications were comparable between the study group and the observational cohort. Conclusion: In people with T1D and unsatisfactory diabetes control the introduction of CSII and CGM results in a substantial and long-term improvement.


Author(s):  
Melike Şahinol ◽  
Gülşah Başkavak

AbstractThe conventional treatment of Type 1 Diabetes (T1D) is especially demanding for children, both physically and psychologically (Iversen et al. Int J Qual Stud Health Well-being,13(1), 1487758, 2018). Continuous Glucose Monitoring Systems (CGM) are an important aid for children and their families in dealing with the disease. In their work, however, Şahinol and Başkavak (2020) point out that CGM carry the risk of viewing T1D as a technologically solvable problem instead of considering the disease as a whole. This is mainly creating confidence in technology due to CGM experiences while neglecting significant dietary measures and exercises needed to be integrated into daily routines. During the current pandemic, this problem seems to take on a whole new level. Based on two periods of in-depth interviews and observations conducted with 8 families with T1D children aged 6 to 14 living in Istanbul and Ankara (Turkey) from May to November 2019 and again from May to June 2020, we compare and focus on the experiences prior to and during the pandemic time. We argue that despite the possibility of technological regulation of the disease, the vulnerability of children is increased and, more than ever, depends on socio-bio-technical entanglements.


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