UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046858 |
|---|---|
| Receipt number | R000053392 |
| Scientific Title | Exploring the impact of nutrition advice on blood sugar and psychological status using Continuous Glucose Monitoring (CGM) and wearable devices: A feasibility study |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2025/02/19 13:21:58 |
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Basic information
Public title
Exploring the impact of nutrition advice on blood sugar and psychological status using Continuous Glucose Monitoring (CGM) and wearable devices: A feasibility study
Acronym
Exploring the impact of nutrition advice on blood sugar and psychological status using Continuous Glucose Monitoring (CGM) and wearable devices: A feasibility study
Scientific Title
Exploring the impact of nutrition advice on blood sugar and psychological status using Continuous Glucose Monitoring (CGM) and wearable devices: A feasibility study
Scientific Title:Acronym
Exploring the impact of nutrition advice on blood sugar and psychological status using Continuous Glucose Monitoring (CGM) and wearable devices: A feasibility study
Region
| Japan |
Condition
Condition
Healthy Adult and Glucose intolerance
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study exploratively examines the relationship between blood glucose variability, activities of daily living obtained from wearable devices and psychological state obtained from questionnaires. Also, the extent to which the intervention effect of advice about eating behavior influences these outcomes is verified.
Basic objectives2
Others
Basic objectives -Others
This study is conducted with a limited number of subjects as a feasibility study for subsequent studies of a larger scale.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of data collected by CGM and wearable devices over the study period.
Key secondary outcomes
-Brief-type self-administered diet history questionnaire (BDHQ) and dietary behavior questionnaire
-Perceived Stress Scale (Perceived Stress Scale) as a questionnaire on stress
-Satisfaction With Life Scale (SWLS), Scale of Positive and Negative Experience (SPANE-J : Japanese version), Flourishing Scale (FS-J: Japanese version) as a questionnaire on well-being
-Epworth Sleepiness Scale (ESS : Japanese version) as a questionnaire on sleepiness
-Visual Analogue Scale (VAS) to assess sleepiness, mood, and energy
-Calculate the following as blood glucose level variation (A)
Coefficient of Variation (CV)
-Other indices of blood glucose variation (A), postprandial blood glucose (B), and postprandial hypoglycemia (C) will be calculated as follows:
(A) Mean Amplitude of Glycemic Excursions (MAGE), Time In Range (TIR)
(B) Area Under the Curve (AUC)
(C) Area Over the Curve (AOC)
-Exploratory endpoints: The following will be calculated as other indices of blood glucose variability (A) and postprandial blood glucose (B)
(A) Number of glucose spikes (B) Estimated HbA1c
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study provides advice on eating behavior but does not involve interventions such as therapeutic drugs.
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
1)Individuals with HbA1c values of greater than or equal to 5.8 and less than 6.5 at the most recent physical examination within the past year or healthy individuals with no evidence of glucose intolerance
2)Those who are at least 20 years old at the time of obtaining consent
3)Individuals who own and use a smartphone that can be used with an application for completing data
Key exclusion criteria
1) Individuals who have been diagnosed with diabetes in the past and are undergoing treatment
2) Patients with comorbidities that may affect the measurement results of the wristband wearable device, such as paralysis of the upper limbs.
3) Other patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kashiwagi |
Organization
Keio University School of Medicine/Keio University Hospital
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, Minato-ku, Tokyo
TEL
03-5363-3447
kashiwagi.z2@keio.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Kinoshita |
Organization
Keio University School of Medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, Minato-ku, Tokyo, 106-0032
TEL
03-5786-0006
Homepage URL
shotaro.kinoshita@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Institute
Department
Personal name
Funding Source
Organization
Research funds of Keio University School of Medicine, Hills Joint Research Laboratory for Future Preventive Medicine and Wellness (provided by Mori Building Co., Ltd.)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
Shinanomachi35, Shinjuku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
| 2022 | Year | 02 | Month | 21 | 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
40
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
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053392
