UMIN-CTR Clinical Trial

Basic information
Public title	Effect of diabetes prevention program using Flash Glucose Monitoring
Acronym	Effect of diabetes prevention program using Flash Glucose Monitoring
Scientific Title	Effect of diabetes prevention program using Flash Glucose Monitoring
Scientific Title:Acronym	Effect of diabetes prevention program using Flash Glucose Monitoring
Region	Japan

Condition
Condition	prediabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study targets health checkups with impaired glucose tolerance or suspected glucose tolerance, and continues to provide intervention (health guidance) by public health nurses based on activity meters and dietary photographs. In addition, the Flash Glucose Monitoring system visualizes 24-hour continuous blood glucose fluctuations to scientifically determine whether the subject can promote and maintain behavior change and improve body weight, muscle mass, lipids, and metabolic control. This is an intervention study that aims to prove on a statistical basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the amount of change in each measurement timing(after the completion of health guidance, the next year's regular health checkup) of HbA1c between the FGM + health guidance group and the health guidance group
Key secondary outcomes	The following items will be compared before and after the intervention in both groups (FGM + health guidance group and health guidance group). Fasting blood glucose level, uric acid, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, renal function, insulin, body weight, BMI, blood pressure, body composition (muscle mass, fat mass), BDHQ. Comparison of 24-hour average blood glucose level and Time in range between night shift workers and non-night shift workers. Comparison of 24-hour mean blood glucose and Time in range before and after intervention in FGM + health guidance group.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	FGM + health guidance group (with FGM) This is a diabetes prevention program in which a public health nurse gives health guidance to a subject seven times in three months via a smartphone based on activity meters and daily meal photo data. In the FGM + health guidance group (with FGM ), health guidance will be provided using the results of FGM at the time of health guidance.
Interventions/Control_2	Health guidance group (without FGM) This is a diabetes prevention program in which a public health nurse gives health guidance to a subject seven times in three months via a smartphone based on activity meters and daily meal photo data.
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	1) Regular health checkups and health insurance union staff with HbA1c 5.6-6.4% in the 2020 regular health checkup results 2) Men and women over 20 years old (at the time of obtaining consent) 3) Subjects who have written consent to participate in this study 4) Those who can wear FGM 5) You must agree to the health management guidelines of Panasonic Health Insurance. 6) Those who meet all of the following diabetes prevention program participation requirements - Do not take any medication related to diabetes treatment -Do not take medication for diseases other than diabetes (if you are taking medication, diabetes prevention plan) Check with your doctor about your participation in the program) - You must have a contactable email address -Own a smartphone that can download apps (so-called feature phones / tablet devices cannot be substituted) -You must own a computer connected to the Internet at home (a tablet terminal cannot be used as a substitute).
Key exclusion criteria	1) Those judged by the doctor to be contraindicated in exercise therapy (NYHA 2nd degree or higher heart disease, etc.) 2) Pregnant or lactating women 3) Those who are equipped with other implantable medical devices such as pacemakers 4) When the doctor deems it inappropriate in terms of safety, etc.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name KEISUKE Middle name Last name KUNIEDA
Organization	Panasonic Health Insurance Organization,Health care center
Division name	Health care center
Zip code	570-8540
Address	moriguthishi sotojimamatthi 5-55
TEL	06-6992-7070
Email	keisuke.kunieda@jp.panasonic.com

Public contact
Name of contact person	1st name KEISUKE Middle name Last name KUNIEDA
Organization	Panasonic Health Insurance Organization,Health care center
Division name	Health care center
Zip code	570-8540
Address	moriguthishi sotojimamatthi 5-55
TEL	06-6992-7070
Homepage URL
Email	keisuke.kunieda@jp.panasonic.com

Sponsor
Institute	Panasonic Health Insurance Organization,Health care center
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Panasonic Health Insurance Organization,Matsushita Memorial Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Panasonic Health Insurance Organization,Health care center
Address	moriguthishi sotojimamatthi 5-55
Tel	06-6992-7070
Email	keisuke.kunieda@jp.panasonic.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 24 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	2020 Year 11 Month 17 Day
Date of IRB	2020 Year 11 Month 20 Day
Anticipated trial start date	2020 Year 11 Month 24 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 11 Month 21 Day
Last modified on	2020 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048494