PMID- 34130445
OWN - NLM
STAT- MEDLINE
DCOM- 20220308
LR  - 20220308
IS  - 2233-6087 (Electronic)
IS  - 2233-6079 (Print)
IS  - 2233-6079 (Linking)
VI  - 46
IP  - 1
DP  - 2022 Jan
TI  - Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL 
      in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION 
      Study): A Randomized Controlled Trial.
PG  - 71-80
LID - 10.4093/dmj.2020.0274 [doi]
AB  - BACKGROUND: To compare the efficacy and safety of two insulin self-titration 
      algorithms, Implementing New Strategies with Insulin Glargine for Hyperglycemia 
      Treatment (INSIGHT) and EDITION, for insulin glargine 300 units/mL (Gla-300) in 
      Korean individuals with uncontrolled type 2 diabetes mellitus (T2DM). METHODS: In 
      a 12-week, randomized, open-label trial, individuals with uncontrolled T2DM 
      requiring basal insulin were randomized to either the INSIGHT (adjusted by 1 
      unit/day) or EDITION (adjusted by 3 units/week) algorithm to achieve a fasting 
      self-monitoring of blood glucose (SMBG) in the range of 4.4 to 5.6 mmol/L. The 
      primary outcome was the proportion of individuals achieving a fasting SMBG </=5.6 
      mmol/L without noct urnal hypoglycemia at week 12. RESULTS: Of 129 individuals 
      (age, 64.1+/-9.5 years; 66 [51.2%] women), 65 and 64 were randomized to the INSIGHT 
      and EDITION algorithms, respectively. The primary outcome of achievement was 
      comparable between the two groups (24.6% vs. 23.4%, P=0.876). Compared with the 
      EDITION group, the INSIGHT group had a greater reduction in 7-point SMBG but a 
      similar decrease in fasting plasma glucose and glycosylated hemoglobin. The 
      increment of total daily insulin dose was significantly higher in the INSIGHT 
      group than in the EDITION group (between-group difference: 5.8+/-2.7 units/day, 
      P=0.033). However, body weight was significantly increased only in the EDITION 
      group (0.6+/-2.4 kg, P=0.038). There was no difference in the occurrence of 
      hypoglycemia between the two groups. Patient satisfaction was significantly 
      increased in the INSIGHT group (P=0.014). CONCLUSION: The self-titration of 
      Gla-300 using the INSIGHT algorithm was effective and safe compared with that 
      using the EDITION algorithm in Korean individuals with uncontrolled T2DM 
      (ClinicalTrials.gov number: NCT03406663).
FAU - Bae, Jae Hyun
AU  - Bae JH
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
AD  - Department of Internal Medicine, Korea University Anam Hospital, Korea University 
      College of Medicine, Seoul, Korea.
FAU - Ahn, Chang Ho
AU  - Ahn CH
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Korea.
FAU - Yang, Ye Seul
AU  - Yang YS
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
AD  - Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Uijeongbu, Korea.
FAU - Moon, Sun Joon
AU  - Moon SJ
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
AD  - Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan 
      University School of Medicine, Seoul, Korea.
FAU - Kwak, Soo Heon
AU  - Kwak SH
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Jung, Hye Seung
AU  - Jung HS
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Park, Kyong Soo
AU  - Park KS
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Cho, Young Min
AU  - Cho YM
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT03406663
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210616
PL  - Korea (South)
TA  - Diabetes Metab J
JT  - Diabetes & metabolism journal
JID - 101556588
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Aged
MH  - Algorithms
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Insulin Glargine/adverse effects
MH  - Middle Aged
MH  - Republic of Korea/epidemiology
PMC - PMC8831820
OTO - NOTNLM
OT  - Algorithms
OT  - Blood glucose self-monitoring
OT  - Diabetes mellitus, type 2
OT  - Hypoglycemia
OT  - Insulin glargine
OT  - Patient satisfaction
OT  - Pragmatic clinical trial
COIS- CONFLICTS OF INTEREST No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2021/06/17 06:00
MHDA- 2022/03/09 06:00
PMCR- 2022/01/01
CRDT- 2021/06/16 03:37
PHST- 2020/11/24 00:00 [received]
PHST- 2021/02/04 00:00 [accepted]
PHST- 2021/06/17 06:00 [pubmed]
PHST- 2022/03/09 06:00 [medline]
PHST- 2021/06/16 03:37 [entrez]
PHST- 2022/01/01 00:00 [pmc-release]
AID - dmj.2020.0274 [pii]
AID - dmj-2020-0274 [pii]
AID - 10.4093/dmj.2020.0274 [doi]
PST - ppublish
SO  - Diabetes Metab J. 2022 Jan;46(1):71-80. doi: 10.4093/dmj.2020.0274. Epub 2021 Jun 
      16.