Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study

Abstract

Introduction To evaluate in an Italian real-world setting the safety and effectiveness of insulin degludec 100 units/mL, given once daily in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) after switching from other basal insulins. Methods ReFLeCT was a multicenter, prospective, observational study conducted across seven European countries which involved adult patients whose physician planned to switch their medication from basal insulin to insulin degludec. The primary outcome was the change in the number of hypoglycemic episodes before and after the switch to insulin degludec. Results are expressed as 12-month follow-up/baseline incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs). Results The Italian cohort of the ReFLect study comprised 148 patients with T1DM and 311 patients with T2DM. In patients with T1DM, the switch to insulin degludec was associated with significantly lower rates of overall (IRR 0.69, 95% CI 0.57–0.82), non-severe (IRR 0.72, 95% CI 0.60–0.85), and nocturnal hypoglycemia (IRR 0.46, 95% CI 0.31–0.69). Following the switch, hemoglobin A 1c (HbA 1c ) levels decreased significantly by 0.35% (95% CI − 0.50 to − 0.20), with no significant changes in fasting plasma glucose (FPG) and basal insulin dose. Body weight increased by 0.83 kg (95% CI 0.16–1.50). In patients with T2DM, significant reductions in the rates of overall (IRR 0.40, 95% CI 0.29–0.55), non-severe (IRR 0.47, 95% CI 0.34–0.63), and nocturnal hypoglycemia (IRR 0.27, 95% CI 0.09–0.86) were documented. HbA 1c and FPG decreased significantly by 0.45% (95% CI − 0.58 to − 0.31) and 0.90 mmol/L (95% CI − 1.21 to − 0.59], respectively, with no significant changes in basal insulin dose or body weight. Treatment satisfaction significantly improved in both diabetes types. Conclusion In Italian routine clinical practice, switching from other basal insulins to insulin degludec reduced the total episodes of hypoglycemia and improved glycemic control and treatment satisfaction in patients with T1DM and T2DM. Trial Registration ClinicalTrials.gov NCT02392117. Electronic Supplementary Material The online version of this article (10.1007/s13300-020-00936-5) contains supplementary material, which is available to authorized users.

ISPAD Clinical Practice Consensus Guidelines 2022: Ramadan and other religious fasting by young people with diabetes

“…92 Insulin degludec is approved for clinical use from the first year of age and is associated with lower rates of nocturnal hypoglycemia, T A B L E 1 List of commonly eaten food during the month of Ramadan more flexibility in timing of insulin administration and better quality of life compared to other basal insulins. [93][94][95] These advantages might be of utmost importance especially during fasting.…”

A review on generation of real-world evidence

“…The basic requirements for planning and design of research studies include accessibility, affordability, accuracy, advantage or appropriateness, attractiveness, appreciation or awareness, and acceptability [14]. Figure 1 shows the types of studies for RWE [12,[15][16][17][18][19][20][21][22].…”