PMID- 36585035
OWN - NLM
STAT- MEDLINE
DCOM- 20230103
LR  - 20230111
IS  - 2052-4897 (Electronic)
IS  - 2052-4897 (Linking)
VI  - 10
IP  - 6
DP  - 2022 Dec
TI  - The Effect of high temperature on the stability of basal insulin in a pen: a 
      randomized controlled, crossover, equivalence trial.
LID - 10.1136/bmjdrc-2022-003105 [doi]
LID - e003105
AB  - INTRODUCTION: Insulin is an essential medicine in the management of diabetes. 
      When stored at high temperatures(HTs), its efficacy could rapidly decline. 
      Therefore, appropriate storage of in-use insulin is necessary to achieve its 
      maximum therapeutic effects. However, the ambient temperature in tropical 
      countries is normally relatively high. This study aimed to compare the efficacies 
      of basal insulin in a pen previously kept at 37 degrees C for 21 days and basal insulin 
      in a refrigerated pen (2 degrees C-8 degrees C). Continuous glucose monitoring (CGM) was used to 
      evaluate daily mean glucose levels (MGLs). RESEARCH DESIGN AND METHODS: This 
      randomized controlled, crossover, equivalence trial recruited adults with type 2 
      diabetes mellitus and glycated hemoglobin levels <8% who had used insulin 
      glargine for >3 months. Subjects were randomized for sequential use of 
      refrigerated basal insulin followed by basal insulin kept at HT, with a 2-week 
      washout between phases. The HT insulin pens were stored in a 37 degrees C incubator for 
      21 days before use, while the refrigerated insulin pens were stored at 2 degrees C-8 degrees C. 
      Study patients received 7-day CGM. The primary outcome was the difference in the 
      groups' MGLs. The secondary outcome parameters were glucose variability 
      represented by the standard deviation (SD), mean amplitude of glycemic excursion 
      (MAGE), and percentage of time in range (TIR). The remaining quantity of insulin 
      was evaluated by ultrahigh-performance liquid chromatography (UHPLC) assay. 
      RESULTS: Forty patients completed the study. The MGLwas 158.7+/-30.5 mg/dL and 
      157.0+/-40.9 mg/dL in the HT and refrigerated insulin pen groups, respectively 
      (p=0.72). The groups had no significant differences in MAGE(7day), SD, percentage 
      of TIR, carryover period, or treatment effects (all p>0.05). There was also no 
      significant difference in the remaining quantity of insulin evaluated by UHPLC 
      (p=0.97). CONCLUSIONS: HT basal insulin pens retain their potency and have 
      biological activity comparable to that of refrigerated pens.Trial registration 
      number TCTR20210611002.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Kongmalai, Tanawan
AU  - Kongmalai T
AUID- ORCID: 0000-0002-1192-9267
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Faculty of 
      Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
FAU - Orarachin, Patima
AU  - Orarachin P
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Faculty of 
      Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
FAU - Dechates, Bothamai
AU  - Dechates B
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Faculty of 
      Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
FAU - Chanphibun, Pornnapa
AU  - Chanphibun P
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Faculty of 
      Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
FAU - Junnu, Sarawut
AU  - Junnu S
AD  - Department of Biochemistry, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Srisawat, Chatchawan
AU  - Srisawat C
AD  - Department of Biochemistry, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
AD  - Siriraj Metabolomics and Phenomics Center, Faculty of Medicine Siriraj Hospital, 
      Mahidol University, Bangkok, Thailand.
FAU - Sriwijitkamol, Apiradee
AU  - Sriwijitkamol A
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Faculty of 
      Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand 
      apiradee.sri@mahidol.ac.th.
LA  - eng
SI  - TCTR/TCTR20210611002
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - BMJ Open Diabetes Res Care
JT  - BMJ open diabetes research & care
JID - 101641391
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Insulin)
RN  - 0 (Insulin, Regular, Human)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Hypoglycemic Agents/therapeutic use
MH  - Temperature
MH  - Insulin, Long-Acting/therapeutic use
MH  - Blood Glucose Self-Monitoring
MH  - Blood Glucose/analysis
MH  - Glycated Hemoglobin
MH  - Insulin/therapeutic use
MH  - Insulin, Regular, Human
PMC - PMC9809263
OTO - NOTNLM
OT  - Continuous Glucose Monitoring
OT  - Diabetes Mellitus, Type 2
OT  - Insulin
OT  - Patient Education as Topic
COIS- Competing interests: None declared.
EDAT- 2022/12/31 06:00
MHDA- 2023/01/04 06:00
PMCR- 2022/12/30
CRDT- 2022/12/30 20:53
PHST- 2022/08/30 00:00 [received]
PHST- 2022/12/12 00:00 [accepted]
PHST- 2022/12/30 20:53 [entrez]
PHST- 2022/12/31 06:00 [pubmed]
PHST- 2023/01/04 06:00 [medline]
PHST- 2022/12/30 00:00 [pmc-release]
AID - 10/6/e003105 [pii]
AID - bmjdrc-2022-003105 [pii]
AID - 10.1136/bmjdrc-2022-003105 [doi]
PST - ppublish
SO  - BMJ Open Diabetes Res Care. 2022 Dec;10(6):e003105. doi: 
      10.1136/bmjdrc-2022-003105.