Healthy Adult and Glucose intolerance
Conditions
Interventions
This study provides advice on eating behavior but does not involve interventions such as therapeutic drugs.
Sponsors
Keio University School of Medicine Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of data collected by CGM and wearable devices over the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| -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 | — |
Countries
Japan
Contacts
Public ContactShotaro Kinoshita
Keio University School of Medicine Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Outcome results
None listed