A multicenter, retrospective, observational study of the safety and efficacy of the patch pump MEDISAFE WITH

A multicenter, retrospective, observational study of the safety and efficacy of the patch pump MEDISAFE WITH - MW-Safety Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055106

Enrollment

125

Registered

2024-07-29

Start date

2024-07-01

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

Type 1 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.type 1 diabetes 2.Patients who newly introduced Medisafe with from June 1, 2019 to June 30, 2023

Exclusion criteria

Exclusion criteria: Patients judged by the research director to be unsuitable as research subjects

Design outcomes

Primary

Measure	Time frame
1. Frequency of diabetic ketoacidosis occurrence within 26 weeks of MediSafe With introduction. 2. Frequency of severe hypoglycemia within 26 weeks of MediSafe With introduction.	—

Secondary

Measure	Time frame
1.Frequency of diabetic ketoacidosis occurrence within 13 weeks of MediSafe With introduction 2.Frequency of severe hypoglycemia within 13 weeks of MediSafe With introduction 3.Changes in HbA1c from the time of MediSafe With introduction to 26 weeks later 4.Changes in basal insulin dose and bolus insulin dose from the time of MediSafe With introduction to 26 weeks later 5.Changes in weight from the time of MediSafe With introduction to 26 weeks later 6.Frequency of adverse events 7.Frequency of contact dermatitis 8.Frequency of serious adverse events 9.Frequency of adverse events related to the study device 10.Frequency of malfunctions of the study device 11.Reasons for discontinuation and HbA1c values at the time of discontinuation in cases where MediSafe With was stopped during the observation period, and whether another insulin pump was used after discontinuation 12.Use of intermittently scanned continuous glucose monitoring (isCGM) during the observation period 13.Use of real-time continuous glucose monitoring (rtCGM) and manufacturer names during the observation period	—

Measure

Time frame

1.Frequency of diabetic ketoacidosis occurrence within 13 weeks of MediSafe With introduction 2.Frequency of severe hypoglycemia within 13 weeks of MediSafe With introduction 3.Changes in HbA1c from the time of MediSafe With introduction to 26 weeks later 4.Changes in basal insulin dose and bolus insulin dose from the time of MediSafe With introduction to 26 weeks later 5.Changes in weight from the time of MediSafe With introduction to 26 weeks later 6.Frequency of adverse events 7.Frequency of contact dermatitis 8.Frequency of serious adverse events 9.Frequency of adverse events related to the study device 10.Frequency of malfunctions of the study device 11.Reasons for discontinuation and HbA1c values at the time of discontinuation in cases where MediSafe With was stopped during the observation period, and whether another insulin pump was used after discontinuation 12.Use of intermittently scanned continuous glucose monitoring (isCGM) during the observation period 13.Use of real-time continuous glucose monitoring (rtCGM) and manufacturer names during the observation period

—

Countries

Japan

Contacts

Public ContactJunnosuke Miura

Tokyo Women's Medical University School of Medicine Division of Diabetology and Metabolism, Department of Internal Medicine

jmiura.dmc@twmu.ac.jp03-3353-8111

Outcome results