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

Phase 3

Recruiting

• Conditions: Diabetes Type 2

• Registration Number: JPRN-jRCT2032220603
• Lead Sponsor: Waki Kayo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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 <=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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified