UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037028 |
|---|---|
| Receipt number | 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 | 2022/01/06 11:16:28 |
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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
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
takagi.satoshi.dmc@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical university
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
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
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042183
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
