PMID- 29504812
OWN - NLM
STAT- MEDLINE
DCOM- 20190916
LR  - 20190916
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 34
IP  - 6
DP  - 2018 Jun
TI  - Comparative usability study of the dulaglutide single-use pen versus the insulin 
      degludec FlexTouch((R)) among self-injection-naive patients with type 2 diabetes 
      mellitus in Japan.
PG  - 1117-1124
LID - 10.1080/03007995.2018.1448260 [doi]
AB  - OBJECTIVE: This study assessed training time with the dulaglutide single-use pen 
      (SUP) and the insulin degludec disposable prefilled pen (FlexTouch((R))) in 
      self-injection-naive patients with type 2 diabetes mellitus (T2DM) in Japan. 
      METHODS: This multi-center, open-label, comparative, crossover study measured 
      training time with the dulaglutide SUP vs FlexTouch((R)). Participants learned how 
      to use both devices in a randomly assigned order. Healthcare providers (HCP) 
      conducted the training. The primary end-point was the time required to train 
      self-injection-naive T2DM participants to self-inject correctly using each 
      device. Secondary end-points included performance measures, such as success and 
      error rates, patient perceptions related to ease-of-use, and factors associated 
      with training time and performance. RESULTS: Overall, 48 participants were 
      randomized and completed the study. The mean training time to achieve correct 
      administration was significantly shorter with the dulaglutide SUP vs FlexTouch((R)) 
      (7.4 min vs 19.7 min, p < .001). The proportions of participants who successfully 
      completed the mock injection without error were similar for both devices. 
      Ninety-two percent (44/48) of participants reported that the dulaglutide SUP was 
      easier to use than FlexTouch((R)). CONCLUSIONS: In this study, participants 
      required a shorter training time to achieve correct administration with the 
      dulaglutide SUP, and had a higher preference for the dulaglutide SUP, when 
      compared to FlexTouch((R)). These data suggest that the dulaglutide SUP is 
      easy-to-use, which may decrease the burden on HCPs to train diabetic patients how 
      to administer injection therapy and reduce patient injection hurdles, such as 
      needle fear.
FAU - Asakura, Toshinari
AU  - Asakura T
AD  - a Faculty of Pharmaceutical Sciences , Niigata University of Pharmacy and Applied 
      Life Sciences , Niigata city , Niigata , Japan.
FAU - Suzuki, Shuichi
AU  - Suzuki S
AD  - b Eli Lilly Japan, K.K. , Chuo-Ku, Kobe , Japan.
FAU - Aranishi, Toshihiko
AU  - Aranishi T
AUID- ORCID: 0000-0001-8862-9468
AD  - b Eli Lilly Japan, K.K. , Chuo-Ku, Kobe , Japan.
FAU - Cai, Zhihong
AU  - Cai Z
AD  - b Eli Lilly Japan, K.K. , Chuo-Ku, Kobe , Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180312
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Immunoglobulin Fc Fragments)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 54Q18076QB (insulin degludec)
RN  - 62340-29-8 (Glucagon-Like Peptides)
RN  - WTT295HSY5 (dulaglutide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - *Diabetes Mellitus, Type 2/blood/drug therapy
MH  - Female
MH  - Glucagon-Like Peptides/administration & dosage/adverse effects/*analogs & 
      derivatives
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - *Immunoglobulin Fc Fragments/administration & dosage/adverse effects
MH  - Injections/instrumentation/methods/psychology
MH  - *Insulin Infusion Systems/psychology/statistics & numerical data
MH  - *Insulin, Long-Acting/administration & dosage/adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Patient Outcome Assessment
MH  - Patient Preference/*statistics & numerical data
MH  - *Recombinant Fusion Proteins/administration & dosage/adverse effects
MH  - Self Administration/methods/psychology
OTO - NOTNLM
OT  - Diabetes mellitus
OT  - Dulaglutide
OT  - Injections
OT  - Insulin degludec
OT  - Self-administration
OT  - type 2
EDAT- 2018/03/06 06:00
MHDA- 2019/09/17 06:00
CRDT- 2018/03/06 06:00
PHST- 2018/03/06 06:00 [pubmed]
PHST- 2019/09/17 06:00 [medline]
PHST- 2018/03/06 06:00 [entrez]
AID - 10.1080/03007995.2018.1448260 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2018 Jun;34(6):1117-1124. doi: 10.1080/03007995.2018.1448260. 
      Epub 2018 Mar 12.