UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042516 |
|---|---|
| Receipt number | R000048494 |
| Scientific Title | Effect of diabetes prevention program using Flash Glucose Monitoring |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2020/12/29 14:09:32 |
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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
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
keisuke.kunieda@jp.panasonic.com
Sponsor or person
Institute
Panasonic Health Insurance Organization,Health care center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048494
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