UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Acronym	Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Scientific Title	Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Scientific Title:Acronym	Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time In Range at 1W, 2W, 3W, and 4W.
Key secondary outcomes	The items below are evaluated at 1W, 2W, 3W, and 4W. 1)Standard deviation of blood glucose level 2)Percentage of time above Time In Range and percentage of time below Time In Range 3)Estimated HbA1c 4)Average blood glucose level 5)Number of low glucose events 6)Number of spikes 7)Number of scans by reader The item below is evaluated at 1W, 4W, and 8W. 8)Behavioral change The item below is evaluated at 1W and 4W. 9)BMI The item below is evaluated by pictures. 10)Change of meal contents

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Measuring blood glucose level by freestyle libre at 1W, 2W, 3W, and 4W, provision of messages between 1W and 4W and doctor reports after 1W and 4W by app.
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1)HbA1c was 5.6% -6.9% in the results of medical examinations for the last 2 years. 2)Diagnosed as hypertension and dyslipidemia but not diabetes 3)Consent was obtained from the subject participated in the preliminary briefing session of this study 4)Understand the purpose of research and use Libre properly 5)Daily use of smartphone
Key exclusion criteria	1)Diagnosed as diabetes 2)Having severe kidney disease, liver disease, heart disease, malignant tumor, etc. 3)May be pregnant or within 1 year after childbirth 4)Researchers judge that the participation in the research is inappropriate 5)Consent was obtained from the proxy
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Fujita
Organization	SOMPO Health Support Inc.
Division name	Information system Department
Zip code	101-0063
Address	Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
TEL	0352098500
Email	jfujita46@sompo-hs.co.jp

Public contact
Name of contact person	1st name Hiromasa Middle name Last name Ida
Organization	SOMPO Health Support Inc.
Division name	Business Planning & Development Department
Zip code	101-0063
Address	Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
TEL	0352098523
Homepage URL
Email	hida89@sompo-hs.co.jp

Sponsor
Institute	SOMPO Health Support Inc.
Institute
Department

Funding Source
Organization	Sompo Holdings, Inc,
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	Yamate Hifuka Clinic IRB
Address	ST Shibuya Building, Dougenzaka 1-15-14, Shibuya-ku, Tokyo
Tel	0364169032
Email	yamate@clinic-irb.com

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	2020 Year 11 Month 26 Day

Related information
URL releasing protocol	Unpublished due to the protocol including the intellectual property rights
Publication of results	Unpublished

Result
URL related to results and publications	Working in progress
Number of participants that the trial has enrolled	50
Results	Significant differences were found in the endpoints.
Results date posted	2020 Year 11 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy adults
Participant flow	50 participants completed and 50 subjects were incorporated into the analyses
Adverse events	Mild inflammation on the site where Libre sensor was attached to one subject was occurred.
Outcome measures	Blood glucose level and behavior change
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 12 Month 23 Day
Date of IRB	2020 Year 01 Month 15 Day
Anticipated trial start date	2020 Year 02 Month 06 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 26 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048583