UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055106 |
|---|---|
| Receipt number | R000062495 |
| Scientific Title | A multicenter, retrospective, observational study of the safety and efficacy of the patch pump MEDISAFE WITH |
| Date of disclosure of the study information | 2024/07/29 |
| Last modified on | 2025/01/17 16:48:37 |
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Basic information
Public title
A multicenter, retrospective, observational study of the safety and efficacy of the patch pump MEDISAFE WITH
Acronym
MW-Safety Study
Scientific Title
A multicenter, retrospective, observational study of the safety and efficacy of the patch pump MEDISAFE WITH
Scientific Title:Acronym
MW-Safety Study
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.type 1 diabetes
2.Patients who newly introduced Medisafe with from June 1, 2019 to June 30, 2023
Key exclusion criteria
Patients judged by the research director to be unsuitable as research subjects
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Junnosuke |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Women's Medical University School of Medicine
Division name
Division of Diabetology and Metabolism, Department of Internal Medicine
Zip code
1628666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
jmiura.dmc@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Junnosuke |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Women's Medical University School of Medicine
Division name
Division of Diabetology and Metabolism, Department of Internal Medicine
Zip code
1628666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
jmiura.dmc@twmu.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University ethics committee
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
kshien-manager.bm@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062495
