PMID- 36378018
OWN - NLM
STAT- MEDLINE
DCOM- 20221216
LR  - 20230124
IS  - 1744-7593 (Electronic)
IS  - 1742-5247 (Linking)
VI  - 19
IP  - 12
DP  - 2022 Dec
TI  - Needle-free injection of basal insulin improves fasting glucose variability as 
      assessed by continuous glucose monitoring in T2DM: a prospective randomized 
      multicenter open-label crossover study.
PG  - 1725-1734
LID - 10.1080/17425247.2022.2147504 [doi]
AB  - BACKGROUND: Fasting glucose variability (FGV) extensively promotes the onset and 
      development of diabetic complications. This study aimed to evaluate the FGV in 
      type 2 diabetes mellitus (T2DM) patients administered basal insulin using a 
      needle-free insulin injector (NFII). RESEARCH DESIGN AND METHODS: This was a 
      prospective randomized multicenter open-label crossover study. We randomly 
      assigned 48 T2DM patients to receive basal insulin by NFII or conventional 
      insulin pen (CIP) for 7-14 days and were then crossed over after washout. We 
      conducted continuous glucose monitoring to investigate the FGV, our primary 
      outcome was a composite parameter of the FGV with a fasting blood glucose target 
      between 4.4 and 6.1 mmol/L. RESULTS: The coefficient of variation for sensor 
      glucose at 6 a.m. with CIP was 11.67 (8.70,14.81)% vs. 9.48 (6.48,12.24)% with 
      NFII (p = 0.003), and the coefficient of variation for mean sensor glucose at 5-6 
      a.m. with CIP was 12.70 (9.17,16.56)% vs. 9.23 (7.01,11.98)% with NFII (p 
      < 0.001). The overall basal insulin dosage with CIP injection was 18.00 (16.00, 
      20.00) IU vs. 16.00 (12.00, 19.00) IU during NFII (p < 0.003). CONCLUSION: 
      Compared with CIP, the use of the NFII to inject basal insulin improved FGV in 
      T2DM. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn Identifier is 
      ChiCTR2000034674.
FAU - Sun, Fei
AU  - Sun F
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Gao, Bin
AU  - Gao B
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Yang, Aili
AU  - Yang A
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Ren, Lijun
AU  - Ren L
AD  - Department of Endocrinology, Xi'an International Medical Center Hospital, Xi'an 
      710100, P.R. China.
FAU - Xing, Ying
AU  - Xing Y
AD  - Department of Endocrinology, Xi'an Daxing Hospital, Xi'an 710000, P.R. China.
FAU - Ma, Kaiyan
AU  - Ma K
AD  - Department of Endocrinology, Shangluo Central Hospital, Shangluo 726000, Shaanxi, 
      P.R. China.
FAU - Tian, Li
AU  - Tian L
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Li, Simin
AU  - Li S
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Heng, Chunni
AU  - Heng C
AD  - Department of Endocrinology, Tangdu Hospital, Air Force Medical University, Xi'an 
      710038, P.R. China.
FAU - Liu, Hao
AU  - Liu H
AD  - The Key Laboratory of Biomedical Information Engineering of Ministry of 
      Education, School of Life Science and Technology, Xi'an Jiaotong University, 
      Xi'an 710049, P.R. China.
AD  - Bioinspired Engineering and Biomechanics Center (BEBC), Xi'an Jiaotong 
      University, Xi'an 710049, P.R. China.
FAU - Zhou, Jie
AU  - Zhou J
AD  - Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical 
      University, Xi'an 710032, P.R. China.
FAU - Ji, Qiuhe
AU  - Ji Q
AUID- ORCID: 0000-0002-4008-2974
AD  - Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical 
      University, Xi'an 710032, P.R. China.
LA  - eng
SI  - ChiCTR/ChiCTR2000034674
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20221117
PL  - England
TA  - Expert Opin Drug Deliv
JT  - Expert opinion on drug delivery
JID - 101228421
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - IY9XDZ35W2 (Glucose)
RN  - 0 (Insulin)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Blood Glucose
MH  - Hypoglycemic Agents/therapeutic use
MH  - Cross-Over Studies
MH  - Blood Glucose Self-Monitoring
MH  - Glucose
MH  - Prospective Studies
MH  - Insulin/therapeutic use
MH  - Fasting
OTO - NOTNLM
OT  - basal insulin
OT  - continuous glucose monitoring
OT  - fasting glucose variability
OT  - needle-free insulin injection
OT  - type 2 diabetes mellitus
EDAT- 2022/11/16 06:00
MHDA- 2022/12/17 06:00
CRDT- 2022/11/15 09:42
PHST- 2022/11/16 06:00 [pubmed]
PHST- 2022/12/17 06:00 [medline]
PHST- 2022/11/15 09:42 [entrez]
AID - 10.1080/17425247.2022.2147504 [doi]
PST - ppublish
SO  - Expert Opin Drug Deliv. 2022 Dec;19(12):1725-1734. doi: 
      10.1080/17425247.2022.2147504. Epub 2022 Nov 17.