The Effect of high temperature on the stability of basal insulin in a pen: a randomized controlled, crossover, equivalence trial.
Continuous Glucose Monitoring
Diabetes Mellitus, Type 2
Insulin
Patient Education as Topic
Journal
BMJ open diabetes research & care
ISSN: 2052-4897
Titre abrégé: BMJ Open Diabetes Res Care
Pays: England
ID NLM: 101641391
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
received:
30
08
2022
accepted:
12
12
2022
entrez:
30
12
2022
pubmed:
31
12
2022
medline:
4
1
2023
Statut:
ppublish
Résumé
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°C for 21 days and basal insulin in a refrigerated pen (2°C-8°C). Continuous glucose monitoring (CGM) was used to evaluate daily mean glucose levels (MGLs). 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°C incubator for 21 days before use, while the refrigerated insulin pens were stored at 2°C-8°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. 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 HT basal insulin pens retain their potency and have biological activity comparable to that of refrigerated pens.
Identifiants
pubmed: 36585035
pii: 10/6/e003105
doi: 10.1136/bmjdrc-2022-003105
pmc: PMC9809263
pii:
doi:
Substances chimiques
Hypoglycemic Agents
0
Insulin, Long-Acting
0
Blood Glucose
0
Glycated Hemoglobin
0
Insulin
0
Insulin, Regular, Human
0
Banques de données
TCTR
['TCTR20210611002']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 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.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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