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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037028
Receipt No. R000042183
Scientific Title Trial of blood glucose control and QOL change by sensor augmented pump (SAP) therapy and low glucose suspend (LGS)
Date of disclosure of the study information 2019/06/14
Last modified on 2019/06/15

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Basic information
Public title Trial of blood glucose control and QOL change by sensor augmented pump (SAP) therapy and low glucose suspend (LGS)
Acronym Trial of blood glucose control and QOL change by SAP
Scientific Title Trial of blood glucose control and QOL change by sensor augmented pump (SAP) therapy and low glucose suspend (LGS)
Scientific Title:Acronym Trial of blood glucose control and QOL change by SAP
Region
Japan

Condition
Condition Type 1 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether SAP therapy and LGS are useful for improving glycemic control and QOL of type 1 diabetes patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in glycemic control
Key secondary outcomes QOL, body weight, BMI, insulin dose, frequency of SMBG, hypoglycemia, severe hypoglycemia, and LGS function

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatient or outpatient Patients of Diabetology and Metabolism, Tokyo Women's Medical University Hospital.
20 years old or older at the time of obtaining consent
Diagnosed with type 1 diabetes and start SAP newly.
Obtained written informed consent.
Key exclusion criteria Undergoing hemodialysis
Severe renal failure (eGFR less than 30 ml/min/1.73m2)
Pregnant or potential patients
Patients who the research director judged as inappropriate as subjects.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Babazono
Organization Tokyo Women's Medical university
Division name Diabetology and Metabolism
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL 03-3353-8111
Email babazono.dmc@twmu.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Takagi
Organization Tokyo Women's Medical university
Division name Diabetology and Metabolism
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email takagi.satoshi.dmc@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical university
Institute
Department

Funding Source
Organization Tokyo Women's Medical university
Organization
Division
Category of Funding Organization Self funding
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
Address 8-1 Kawada-cho, Shinjuku, Tokyo, Japan
Tel 0333538111
Email none@none

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
2019 Year 06 Month 14 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 07 Day
Date of IRB
2018 Year 12 Month 07 Day
Anticipated trial start date
2018 Year 12 Month 08 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Inpatients or outpatients who meet the criteria in our department

Management information
Registered date
2019 Year 06 Month 11 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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