Diabetes Type 2
Conditions
Interventions
Device: DKD-ET
The intervention consists of an mHealth-based exercise support system (DKD-ET) that includes an mHealth app, an administrative screen used by a medical professional (either a physician
Sponsors
Waki Kayo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study is targeting people with type 2 diabetes who are able to do exercise, leading to the following inclusion criteria. Patients who meet all of the criteria are eligible for the experiment. 1. Diagnosed with type 2 diabetes (Diabetes mellitus that is thought to have developed as a result of insufficient insulin action due to environmental factors added to a genetic predisposition to insulin secretion and insulin resistance based on the history of present illness, without positive results for autoantibodies such as GAD, IAA, ICA, and IA-2 antibodies in the medical record) 2. In the contemplation, preparation, or action stages of the transtheoretical model (determined by a brief questionnaire at the provisional registration (V0)) 3. HbA1c >= 7.5% and HbA1c = 18 at V0 6. BP = 45mL/min/1.73m2 confirmed at examination at least once in the 12 weeks before V0 or at V0 8. Urine albumin creatinine ratio = 22kg/m2 at V0 10. No incidences in the 12 weeks before V0 of severe hypoglycemic attacks where assistance by others was required 11.No symptoms of a possible hypoglycemic attack (including palpitations, tremors, dizziness, light-headedness, anxiousness, loss of consciousness, sweating, pale face, tachycardia, headache, drowsiness, blurred vision, convulsion) observed in the 12 weeks before V0 12. Able to attend consultations at a specified time during the trial 13. Fully informed about participation in this study, and have given free and voluntary written consent based on a thorough understanding of the study
Exclusion criteria
Exclusion criteria: Patients who are unable to do exercise or do not need to do more exercise are not eligible for the present study, leading to the following exclusion criteria. Patients who meet at least one of the exclusion criteria are excluded from the experiment. 1. In the precontemplation or maintenance stages of the transtheoretical model at V0 2. Walked an average of >= 10,000 steps a day in the four weeks before V0 (must be verifiable by pedometer, etc.) 3. Using a pacemaker 4. Using continuous glucose monitoring (but do not exclude if self-monitoring of blood glucose or intermittently scanned-continuous glucose monitoring was conducted eight weeks or more before V0) 5. Diagnosed with hyperthyroidism and have received treatment other than thyroid hormone replacement in the year before V0 6. Diagnosed with a moderate to severe heart condition that requires exercise restriction as assessed by a physician 7. Require exercise treatment restrictions as assessed by a physician at V0, decision made with reference to "Cases in which exercise therapy should be prohibited or restricted" in the Guidelines for Diabetes Treatment (Japan Diabetes Society, 2022-2023) 8. Hb < 10g/dL at V0 9. Serum albumin <= 3.0g/dL at V0 10. Diagnosed with preproliferative retinopathy or retinopathy of a later stage within the year before V0 11. Cannot undergo exercise treatment 12. Pregnancy, including any possibility of or intention of pregnancy 13. Participation in other trials at the time of registration (V2) 14. Impaired cognitive function as determined by the investigator or sub investigator 15. Any other reason that the patient is classified as unfit for participation by the investigator or sub investigator (a record must be kept of the reason the patient was determined to be inappropriate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group differences in the change of HbA1c value, both between baseline (V2) and the end of week 12 (V5), and between baseline (V2) and the end of the intervention period or week 24 (V8). If a participant withdraws from the study before V5 or V8, the change in HbA1c value between V2 and the point of discontinuation will be compared instead. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy Endpoints 1-1)About HbA1c 1)Pre- and post-comparisons between the screening period (registration at V2) and week 12 (V5) or earlier discontinuation in each group, pre- and post-comparisons between the screening period (registration at V2) and week 24 (V8) or earlier discontinuation, and pre- and post-comparisons between the screening period (registration at V2) and week 36 (V9) or earlier discontinuation in each group. 2)Comparison of the change between the two groups from the screening period (registration at V2) to week 12 (V5) or earlier discontinuation, and from the screening period (registration at V2) to week 36 (V9) or earlier discontinuation. 3)Comparison between the two groups of the percentage of participants with HbA1c <7% at Week 12 (V5) or earlier discontinuation, the percentage with <7% at Week 24 (V8) or earlier discontinuation, and the percentage with <7% at Week 36 (V9) or earlier discontinuation. 1-2)Other Efficacy Endpoints For the following variables, comparison between the two groups of the change from the screening period (provisional registration at V0) to week 24 (V8) or earlier discontinuation, and the change from the screening period (provisional registration at V0) to week 12 (V5) or earlier discontinuation. For 2) to 16), comparison between the two groups of the change from the screening period (provisional registration at V0) to week 36 (V9) or earlier at the time of discontinuation. For 1), the screening period (baseline step count at V1), not the screening period (V0 at obtaining consent), will be used as the ex-ante value of change, and pre- and post- comparisons will be made to evaluate the transition. For 17), the pre-value of change will be used after the start of the intervention (V2-V3) instead of during the screening period (provisional registration at V0), and for 2), a pre- and post-comparison will be conducted only in the intervention group. For (18), the values at week 24 (V8) or earlier discontinuation will be ev | — |
Contacts
Public ContactMasayuki Kanezaki
The University of Tokyo Hospital
Outcome results
None listed