Efficacy of in-used insulin pen kept at 37 Celsius for 21 days on mean daily glucose measured by continuous glucose monitoring compare with the effect of newly used insulin pen, the equivalence trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210611002

Enrollment

Registered

2021-06-11

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose lowering effect, assessed by continuous glucose monitoring, in insulin-treated type 2 diabetes patients Mean daily glucose, continuous glucose monitoring, in-use basal insulin pen, temperature, insulin stability

Interventions

in-use insulin pen group: insulin glargine pens were opened and stored in an incubator (37 C) for 21 days before the study periods new insulin pen: Unopened insulin glargine pens were kept in a refrig

Experimental Drug,Active Comparator Drug

In-use insulin pen,New insulin pen

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. type 2 diabetes mellitus (T2DM), 2. taking a stable dose of insulin glargine for at least 3 months, 3. had a glycated hemoglobin (HbA1C) level less than 8%.

Exclusion criteria

Exclusion criteria: 1. HbA1C higher than 8%, 2. use of other insulin apart from insulin glargine, 3. history of severe hypoglycemia within 1 month, 4. recent ischemic stroke or acute myocardial infarction (MI) within 6 months, 5. estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2, 6. psychiatric problems, 7. receiving a drug that affects plasma glucose, such as thiazide, glucocorticoid, or oral contraceptive pill, 8. taken drugs or consumed foods that potentially affect the level of interstitial glucose as measured by CGM, such as paracetamol, atenolol, albuterol, lisinopril, and red wine.

Design outcomes

Primary

Measure	Time frame
mean glucose level obtained from CGM the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring,glucose variability represented by standard deviation (SD), mean amplitude of glycemic excursion (MAGE) the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring,percentage of time in range (TIR), time above range (TAR), and time below range (TBR) the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring	—

Measure

Time frame

mean glucose level obtained from CGM the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring,glucose variability represented by standard deviation (SD), mean amplitude of glycemic excursion (MAGE) the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring,percentage of time in range (TIR), time above range (TAR), and time below range (TBR) the first (days 1-7) and second (days 22-28) phase of the study period continuous glucose monitoring

—

Secondary

Measure	Time frame
Insulin quantification at the end of the study ultra high-performance liquid chromatography (UHPLC)	—

Countries

Thailand

Contacts

Public ContactApiradee Sriwjitkamol

Faculty of Medicine Siriraj Hospital

apiradee.sri@mahidol.ac.th024197799

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026