UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042183