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Study of the effect of "Timesulin" cap with timer function for disposable insulin preparations

Study of the usefulness of "Timesulin", a replacement cap with a timer function for prefilled insulin preparations - SUTIPI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046008
Enrollment
100
Registered
2021-11-08
Start date
2021-11-08
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Diabetes Mellitus

Interventions

Check if you have forgotten to take insulin for 1-2 weeks after informed consent. Use Timesulin from 3rd to 8th week and check for forgetting to inject insulin for 6th-8th week

Sponsors

Diabetes Center, Tokyo Women's Medical Universitiy School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 20 years or older at the time of obtaining consent 2.Patients with a history of insulin self-injection for 1 year or more 3.Patients who inject more than once a day 4.Patients with the latest HbA1c of less than 10% 5.Patients who have forgotten to type at least once in the last 2 weeks 6.Patients who received sufficient explanation before participating in this study, and after sufficient understanding, obtained written consent by the patient himself / herself.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot self-inject 2. Patients who have changed their insulin prescription in the last 3 months 3. Patients who cannot fill out / record the questionnaire and injection record of this survey by themselves 4. Other patients who the principal investigator deems inappropriate as research subjects

Design outcomes

Primary

MeasureTime frame
Incidence rate of forgetting to inject insulin by patients after 8 weeks

Secondary

MeasureTime frame
1.HbA1c 2.Physical findings (BMI, weight, height) 3.QOL 4.Item survey on time constraints that can cause forgetting to type in the QOL questionnaire ITR-QOL 20 5.Timeslin usability and satisfaction survey

Countries

Japan

Contacts

Public ContactJunnosuke Miura

Tokyo Women's Medical Universitiy School of Medicine Diabetes and Metabolism

jmiura.dmc@twmu.ac.jp0333538111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026