PMID- 26886441
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160322
LR  - 20220408
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 7
IP  - 1
DP  - 2016 Mar
TI  - Hypoglycemia Event Rates: A Comparison Between Real-World Data and Randomized 
      Controlled Trial Populations in Insulin-Treated Diabetes.
PG  - 45-60
LID - 10.1007/s13300-016-0157-z [doi]
AB  - INTRODUCTION: Hypoglycemia is the most common adverse effect of diabetes therapy, 
      particularly insulin treatment. Hypoglycemia is associated with considerable 
      clinical and economic burden, and may be under-reported. The aim of this study 
      was to com pare the frequency of hypoglycemic events reported in real-world 
      settings with those reported in clinical trials. METHODS: We conducted a 
      structured literature review in PubMed to identify hypoglycemic event rates in 
      patients with type 1 diabetes mellitus (T1DM) and insulin-treated type 2 diabetes 
      mellitus (T2DM) from real-world data (RWD) and randomized controlled trials 
      (RCTs). The search was restricted to English language, full-text publications 
      from 2010 onwards, reporting on treatment of T1DM or T2DM with basal only, 
      basal-bolus, or premix insulin. RESULTS: The final dataset included 30 studies 
      (11 RWD studies and 19 RCTs). Six studies (RWD, n = 2; RCT, n = 4) reported 
      hypoglycemia event rates in people with T1DM. For all reported categories of 
      hypoglycemia (severe, non-severe, and nocturnal), rates were consistently higher 
      in RWD studies compared with RCTs. Twenty-five studies (RWD, n = 10; RCT, n = 15) 
      reported hypoglycemia event rates in people with insulin-treated T2DM. For T2DM 
      basal-oral therapy; the highest rates were observed in RWD studies, although 
      there was an overlap with RCT rates. For basal-bolus therapy, there was 
      considerable between-study variability but higher rates of severe and non-severe 
      hypoglycemia were generally observed in RWD studies. For T2DM premix insulin, 
      reported rates of hypoglycemia in RWD studies and RCTs were similar. CONCLUSION: 
      We found that higher rates of hypoglycemia are observed in real-world settings 
      compared with clinical trial settings, although there is a large degree of 
      overlap. Due to the inherent constraints of RCTs, they are likely to 
      underestimate the burden of hypoglycemia in clinical practice. Further, 
      high-quality RWD are needed to determine a more accurate incidence of 
      hypoglycemia in clinical practice.
FAU - Elliott, Lisa
AU  - Elliott L
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Fidler, Carrie
AU  - Fidler C
AD  - DRG Abacus, 6 Talisman Business Centre, Bicester, Oxfordshire, UK. 
      cfidler@teamdrg.com.
FAU - Ditchfield, Andrea
AU  - Ditchfield A
AD  - DRG Abacus, 6 Talisman Business Centre, Bicester, Oxfordshire, UK.
FAU - Stissing, Trine
AU  - Stissing T
AD  - Novo Nordisk A/S, Soborg, Denmark.
LA  - eng
PT  - Journal Article
DEP - 20160217
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4801820
OTO - NOTNLM
OT  - Clinical trial data
OT  - Diabetes mellitus
OT  - Hypoglycemia
OT  - Hypoglycemia event rates
OT  - Insulin
OT  - Nocturnal hypoglycemia
OT  - Real world data
OT  - Severe hypoglycemia
EDAT- 2016/02/18 06:00
MHDA- 2016/02/18 06:01
PMCR- 2016/02/17
CRDT- 2016/02/18 06:00
PHST- 2015/12/22 00:00 [received]
PHST- 2016/02/18 06:00 [entrez]
PHST- 2016/02/18 06:00 [pubmed]
PHST- 2016/02/18 06:01 [medline]
PHST- 2016/02/17 00:00 [pmc-release]
AID - 10.1007/s13300-016-0157-z [pii]
AID - 157 [pii]
AID - 10.1007/s13300-016-0157-z [doi]
PST - ppublish
SO  - Diabetes Ther. 2016 Mar;7(1):45-60. doi: 10.1007/s13300-016-0157-z. Epub 2016 Feb 
      17.