PMID- 33011923
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201112
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 11
IP  - 12
DP  - 2020 Dec
TI  - 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.
PG  - 2909-2920
LID - 10.1007/s13300-020-00936-5 [doi]
AB  - 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.
FAU - Fadini, Gian Paolo
AU  - Fadini GP
AUID- ORCID: 0000-0002-6510-2097
AD  - Department of Medicine, University of Padova, Padua, Italy. 
      gianpaolo.fadini@unipd.it.
FAU - Giordano, Carla
AU  - Giordano C
AD  - Section of Endocrinology, Diabetology and Metabolism, Biomedical Department of 
      Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, 
      Italy.
FAU - Salvi, Laura
AU  - Salvi L
AD  - Novo Nordisk Spa, Rome, Italy.
FAU - Nicolucci, Antonio
AU  - Nicolucci A
AD  - The Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, 
      Italy.
CN  - REFLECT Italian Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT02392117
PT  - Journal Article
DEP - 20201003
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC7644665
OTO - NOTNLM
OT  - Hypoglycemia
OT  - Insulin degludec
OT  - Treatment satisfaction
OT  - Type 1 diabetes
OT  - Type 2 diabetes
EDAT- 2020/10/05 06:00
MHDA- 2020/10/05 06:01
PMCR- 2020/10/03
CRDT- 2020/10/04 20:34
PHST- 2020/07/27 00:00 [received]
PHST- 2020/09/19 00:00 [accepted]
PHST- 2020/10/05 06:00 [pubmed]
PHST- 2020/10/05 06:01 [medline]
PHST- 2020/10/04 20:34 [entrez]
PHST- 2020/10/03 00:00 [pmc-release]
AID - 10.1007/s13300-020-00936-5 [pii]
AID - 936 [pii]
AID - 10.1007/s13300-020-00936-5 [doi]
PST - ppublish
SO  - Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 
      2020 Oct 3.