Type 2 Diabetes Type 2 Diabetes
Conditions
Interventions
The AI-powered dietary fiber intake support system for the intervention group consists of a smartphone app (iOS and Android) that delivered intervention features to promote dietary fiber intake and an
Diabetes Mellitus, Type 2
Sponsors
Waki Kayo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosed with T2D and attending the hospital/clinic for T2D treatment 2.HbA1c 7.5% and above 3.Own a smartphone with internet data connection and able to receive SMS (iphone or android) 4.Willing to take all meal photos with their smartphones, and log them on an app 5.Able to attend research appointments at designated times during the research period 6.18 or older in age 7.Fluent in spoken and written Japanese 8.In the contemplation, preparation, and action stage to increase dietary fiber intake according to Transtheoretical Model (TTM) of behavior change 9.Determined by the responsible investigator or co-investigator to have no cognitive impairment. 10.Determined by the responsible investigator or co-investigator to be capable of receiving dietary fiber intervention. 11.Has received a thorough explanation about participation in this study and has provided voluntary, written consent based on a complete understanding of the study.
Exclusion criteria
Exclusion criteria: 1. Age 76 years of age and older 2. Judged by physicians to be unsuitable candidate for dietary intervention 3. Changed T2D medication within the past 8 weeks 4. Currently participating in another clinical research program 5. Undergoing fiber-restricted diet as ordered by physicians 6. History of eating disorder 7. Currently taking fiber supplements 8. Patients with fluid restriction 9. Patients with Crohn's disease, ulcerative colitis, irritable bowel disease, irritable bowel syndrome, and intestinal obstruction 10. Have taken bowel surgery within the last 3 months 11. Have CKD stage 4 and above 12. Patients with hyperkalemia 13. Women who are currently pregnant or actively trying to conceive (are in the process of trying to conceive) 14. Patients whose smartphones are incompatible with the app (including smartphones with operating systems below Android 5.0 and iOS 14.0), either due to the inability to download or run it effectively 15. Any other reason determined by a physician that deems the patient unfit for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference (intervention group - control group) in dietary fiber change (from the time of run in to the end of the intervention period) will be evaluated. The change in dietary fiber from the time of run in and at the end of the intervention period will be calculated as [(average dietary fiber over week 11 and 12)-(average baseline dietary fiber during the run-in)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the following items, the difference in change will be calculated from the time consent was obtained to the end of the intervention period (12 weeks), and to the end of the observation period (24 weeks). 1.HbA1c (%) 2.Weight (kg) 3.BMI (kg/m2) 4.Systolic and diastolic blood pressure (mmHg) 5.eGFR (ml/min/1.73m2) 6.Fasting blood glucose (mg/dL) 7.LDL-C (mg/dL) 8.HDL-C (mg/dL) 9.Triglyceride (mg/dL) | — |
Contacts
Public ContactRyohei Nakada
The University of Tokyo Hospital
Outcome results
None listed