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- de Valk, H.W., et al.
(författare)
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Switching to insulin degludec from other basal insulins reduces rates of hypoglycemia across patient subgroups in routine clinical care : The ReFleCT study
- 2019
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- ReFLeCT, a multicenter, prospective, observational study evaluated the safety and effectiveness of switching from other basal insulins to insulin degludec (degludec) in patients with type 1 (T1D) or type 2 diabetes (T2D) in routine clinical practice. ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and 12-month follow-up period (degludec). The primary endpoint of overall hypoglycemia reported in patient diaries was reduced during the 12-month follow-up period vs. baseline, without compromising glycemic control. In pre-specified subgroup analyses of the primary endpoint, we assessed if the overall result was robust in different subgroups, characterized according to baseline A1C (<7.5, ≥7.5-<8.5, ≥8.5-<9.5, ≥9.5%), diabetes duration (quartiles) and physician’s reason for initiating degludec (hypoglycemia [Yes/No]). The estimated rate ratios of hypoglycemia were similar within subgroups (no significant interactions), and demonstrated overall lower rates (the majority significantly lower) during the 12-month follow-up periods vs. baseline in patients with T1D or T2D (Figure). Irrespective of baseline characteristics or physician’s reason for initiating degludec, switching to degludec from other basal insulins reduced rates of overall hypoglycemia in patients with T1D or T2D, in routine clinical practice.
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- Fadini, G. P., et al.
(författare)
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Reduced rates of overall hypoglycaemia in patients with Type 1 diabetes after switching to insulin degludec : A European, multinational, multicentre, prospective, observational study (ReFLeCT)
- 2019
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Ingår i: Diabetic Medicine. - : John Wiley & Sons. - 0742-3071 .- 1464-5491. ; 36:Suppl. 1, s. 60-60
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Aims: To evaluate the safety and effectiveness of switching to once‐daily insulin degludec (degludec) from other basal insulins in patients with Type 1 diabetes in routine clinical practice.Methods: ReFLeCT was a multicentre, prospective, observational study in seven European countries in patients (≥18 years) with Type 1 or Type 2 diabetes, whose physician planned to switch their basal insulin to degludec (ClinicalTrials.gov: NCT02392117). ReFLeCT comprised a four week baseline period (pre‐switch basal insulin) and a 12 month follow‐up period (degludec). For the Type 1 diabetes cohort presented here, primary endpoint was changed from baseline in the rate of overall hypoglycaemia recorded in patient diaries.Results: Baseline characteristics (mean [SD]) for patients with Type 1 diabetes (n = 556) were: age 47.4 (15.7) years, diabetes duration 21.4 (13.5) years, HbA1c 8.1 (1.3)% (65.0 [14.2]mmol/mol), fasting plasma glucose (FPG) 8.8 (3.9)mmol/l, pre‐switch basal insulin dose 25.0 (14.1)u/day, body mass index (BMI) 26.1 (4.7)kg/m2 and body weight 76.4 (15.6)kg. Estimated rate ratios of overall (0.80 [0.74; 0.88]95%CI), non‐severe (0.81 [0.74; 0.88]95%CI), severe (American Diabetes Association definition; 0.28 [0.14; 0.56]95%CI) and nocturnal (00:01−05:59am; 0.61 [0.50; 0.73]95%CI) hypoglycaemia illustrated significantly lower rates during 12 month follow‐up vs baseline. HbA1c, FPG and basal insulin dose decreased significantly by –0.15% [–0.23; –0.07]95%CI (–1.64mmol/mol [–2.51; –0.77]95%CI), –0.54mmol/l [–0.95; –0.14]95%CI and –2.21u/day [–2.90; –1.53]95%CI, respectively, and body weight was 0.79kg [0.38; 1.20]95%CI higher, at 12 month follow‐up vs baseline.Conclusion: Switching from other basal insulins to degludec significantly reduced the rates of hypoglycaemia and improved glycaemic control at lower basal insulin doses in patients with Type 1 diabetes in routine clinical practice.
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- Feher, M., et al.
(författare)
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Hypoglycaemia, irrespective of the definition used, is reduced when switching to insulin degludec from other basal insulins in routine clinical care : The ReFLeCT study
- 2019
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background and aims: ReFLeCT was a multicentre, prospective, observational study designed to investigate the safety and effectiveness of switching to insulin degludec (degludec) from other basal insulins in patients with type 1 (T1D) or type 2 diabetes (T2D). Few studies had prospectively collected hypoglycaemia data from patient diaries following a switch to degludec in everyday clinical practice. These additional analyses from the ReFLeCT study aimed to assess the effects of switching to degludec according to different hypoglycaemia definitions.Materials and methods: ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and a 12-month follow-up period (degludec treatment). The primary endpoint of overall hypoglycaemia reported in patient diaries was reduced during follow-up vs baseline in T1D and T2D with improvement of glycaemic control, as previously reported. Here, hypoglycaemia data from ReFLeCT were analysed using pre-specified and updated (post hoc) American Diabetes Association (ADA) hypoglycaemia definitions. Definitions consisted of: documented asymptomatic and symptomatic, pseudo, probable symptomatic, and Level 1, 2 and 3 (severe) hypoglycaemia (Fig). Hypoglycaemic events were analysed using fully adjusted, negative binomial regression models.Results: In T1D (n=556) and T2D (n=611), estimated rate ratios across the previous and the updated ADA hypoglycaemia definitions were significantly lower during the 12-month follow-up vs the baseline period, except for asymptomatic hypoglycaemia in T1D and Level 3 hypoglycaemia in T2D (due to a low number of severe hypoglycaemic events, no comparable statistics were performed) (Fig). Event rates per patient year were also lower for all definitions during the 12-month follow-up vs the baseline period, except for Level 3 hypoglycaemia in T2D, which marginally increased, although this was likely due to the low number of events in this group.Conclusion: In patients with T1D and T2D, switching to degludec from other basal insulins in routine clinical care is associated with lower rates of hypoglycaemia across a broad range of hypoglycaemia definitions, in combination with improved glycaemic control.
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