Reduced rates of overall hypoglycaemia in patients with Type 1 diabetes after switching to insulin degludec : A European, multinational, multicentre, prospective, observational study (ReFLeCT)

• 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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MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

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