An SCT-based digital intervention among type 2 diabetes mellitus patients: an open-label randomized controlled trial

JRCT ID: jRCT2032220603

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes Type 2
• Date of first enrollment: 17/03/2023
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 or a clinical research coordinator overseen by a physician), and a data server. After randomization, the intervention group will watch a video concerning lifestyle modifications, self-management of diabetes, and the effect of exercise on glycemic control. The intervention group will attend consultations with physicians once every four weeks, for 24 weeks. During the consultations, the physicians will provide support regarding usage of the app and lifestyle counselling using a standardized manual. In addition, the physicians will assist the intervention group in using the app to set step goals, define the actions needed to achieve the goals, and identify barriers to behavioral change.
Device: Control Mobile Application
The control consists of a control app for patients to record their daily step count, body weight, and blood pressure. After randomization, the control group will watch the same video as the intervention group, a video concerning lifestyle modifications, self-management of diabetes, and the effect of exercise on glycemic control. The control group will attend consultations with physicians once every four weeks, for 24 weeks, just as the intervention group does. During the consultations, the physicians will provide support regarding usage of the app and lifestyle counselling using a standardized manual, just as is done with the intervention group, but without assisting the group in using the app to set step goals, define the actions needed to achieve the goals, or identify barriers to behavioral change, as the control app does not support these features.

Outcome(s)

• Primary Outcome: 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 Outcome

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 evaluated, and this will be performed only in the intervention group. 19) will be evaluated at the screening period (provisional registration at V0).
1)Daily step count
2)FBG (mg/dL) (more than 5h after a meal)
3)eGFR (L/min/1.73m2)
4)BMI (kg/m2)
5)Systolic and diastolic BP (mmHg)
6)HDL (mg/dL), LDL (mg/dL), TG (mg/dL)
7)Concomitant medication intake (type of medication, daily dosage or weekly dosage for weekly formulation), diabetes medication intake (either increased, unchanged or reduced), and introduction of new medications to treat diabetes, hypertension or dyslipidemia
8)Locomotive syndrome (assessed using Locomo 25)
9)Diabetes self-care (assessed using each subscale score of The Summary of Diabetes Self-Care Activities Measure (SDSCA) Japanese version (Daitoku, 2006) (general diet, special diet, exercise, blood glucose self-monitoring, medication management, foot care))
10)Self-management behavior related to physical activity (assessed using each subscale score and frequency of implementation of each item of the Evaluation scale for self-management behavior related to physical activity of type 2 diabetic patients (ES-SMBPA-2D) (Nakawatase, 2007))
11)Self-regulation of physical activity (assessed using the Japanese version of the Physical Activity Self-Regulation scale (PASR-12)
12)Changes in walking self-efficacy
1)Self-efficacy of achieving targeted daily steps (based on Fukushima, 2011)
2)Self-efficacy of dealing with barriers in achieving targeted daily steps (assessed using Self-Efficacy Scale of Walking Behavior (Nakayama, 2002))
13)Changes in self-efficacy in all health promoting behavior (assessed using the positivity of coping behavior toward disease subscale scores on the Self-Efficacy Scale for Health Behavior (Kim, 1996)
14)Diabetes related emotional distress (assessed using PAID)
15)Changes in diabetes-dependent Quality of Life (assessed using ADDQoL)
16)Walking duration
17)App usage (only for the intervention group)
1) recording rate of BW, step count, BP
2) goal achievement rate (number of days target achieved / number of days in the period of use x 100 (%)), goal increment rate (number of times target increased / number of days target set x 100 (%)), goal reduction rate (number of times target decreased / number of days target set x 100 (%)), average implementation of coping planning strategies or challenges per day (average number of coping planning strategies or challenges implemented per day throughout period of use), barrier identification
18) System feasibility and usability (only for the intervention group)
19) Health Literacy (HLS-14)
2. Safety Endpoints
Frequency of subjective hypoglycemia and contact of the doctor (hypertension) during the study period, frequency of pain occurrence or worsening, and other adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <=10% at the provisional registration (V0)
4. No change in antidiabetic medication (including insulin and GLP-1 receptor agonists) during the eight weeks before V0
5. Age >= 18 at V0
6. BP < 180/110 mmHg at V0
7. eGFR of >= 45mL/min/1.73m2 confirmed at examination at least once in the 12 weeks before V0 or at V0
8. Urine albumin creatinine ratio < 300mg/gCr on at least one occasion in the past year (52 weeks) or at V0
9. BMI >= 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

Exclude 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)

Related Information

• Primary Sponsor: Waki Kayo
• Source(s) of Monetary Support: Raxi co., ltd.