Effect of Monitoring of Step Number on Diabetes

Study Overview
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Brief Summary
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In this study, investigators measured the number of steps, blood pressure, blood glucose, and weight in daily life through the smartphone personal health record application for patients with type 2 diabetes. The efficacy of text message intervention, which encourages an increase in the number of steps per week for 12 weeks, on an increase in the number of daily steps and changes in glucose levels, weight, and blood pressure will be investigated. Also, the durability of intervention will be checked after 12 weeks of intervention ending.

Detailed Description
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This clinical study is a single institution, randomized, prospective study and monitors the average daily number of steps per week using a smartphone personal health record application developed by Samsung Medical Center for patients with type 2 diabetes. The study subjects were divided into five groups such as 1) basal activity (<2500 steps/day), 2) limited activity (2500-4999 steps/day), 3) low activity (5000-7499 steps/day), 4) somewhat active (7500-9999 steps/day), 5) active (10000-12499 steps/day), 6) highly active (≥12500 steps/day)according to the average number of steps per day. During the 12-week period, the intervention group receives the text messages that encourage step-by-step increments every week, and the control group does not receive text messages. The effect of 12-week step monitoring and education on the change in daily step count will be analyzed. Also, the effect of change in daily step count on glucose level, body weight, and blood pressure will be studied.

Official Title
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Effect of Monitoring and Education of Step Number Assessed by Smartphone Application on Blood Glucose, Weight and Blood Pressure in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus, Physical Activity

Intervention / Treatment
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* Other: Text messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 diabetes aged 20-69 years Patients with a HbA1c of less than 8.5% measured during screening (may be replaced by a test value within 3 months of screening visit ) Patients who have not been prescribed diabetic medication for the past 4 weeks or who have taken more than one oral hypoglycemic agent for more than 12 weeks at a certain dose BMI ≥ 23 kg/m2 Available for use Samsung Galaxy S4 or later Android smartphone and wireless internet Patients who voluntarily agreed to participate in this clinical study Exclusion Criteria: Diabetes other than type 2 diabetes, including type 1 diabetes, gestational diabetes Patients who are taking insulin or GLP-1 agonist other than oral hypoglycemic agent Patients with uncontrolled chronic liver disease Patients with acute kidney injury Patients with psychological disorder Patients who are taking weight lowering agent Patients with alcohol or drug addiction within the last 3 Patients who are taking systemic steroid Patients who are breastfeeding or pregnant Patients who did not voluntarily agree to the study Patients who are unsuitable for participation in clinical research

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Send text messages which encourage step-by-step increment of daily step count
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Intervention group receives weekly text messages which encourage the increment of daily step count | Other: Text messages<br>* Text messages which encourage the increment of daily step count<br>|
| No Intervention: Control group<br>Control group does not receive text message | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in daily step count after 12 weeks of intervention | change in daily step count after 12 weeks of intervention | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean daily step count after 12 weeks of intervention | mean daily step count after 12 weeks of intervention | Week 12 | 
| the proportion of patients who reach participant-day during the 12 weeks of intervention | the proportion of patients who reach participant-day during the 12 weeks of intervention The participant-day means the day the participant reach thier upper group of daily step count | Week 12 | 
| mean daily step count at Week 24 | mean daily step count at Week 24 | Week 24 | 
| the proportion of patients who reach participant-day during the Week 13-24 | the proportion of patients who reach participant-day during the Week 13-24 | Week 24 | 
| the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | Week 12 | 
| the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | Week 24 | 
| HbA1c levels | HbA1c levels (%) | Week 12 | 
| HbA1c levels | HbA1c levels (%) | Week 24 | 
| Fasting glucose levels | Fasting glucose levels (mg/dL) | Week 12 | 
| Fasting glucose levels | Fasting glucose levels (mg/dL) | Week 24 | 
| Body weight | Body weight (kg) | Week 12 | 
| Body weight | Body weight (kg) | Week 24 | 
| Blood pressure | Blood pressure (mmHg) | Week 12 | 
| Blood pressure | Blood pressure (mmHg) | Week 24 | 
| IPAQ (international physical activity questionnaire) score | IPAQ (international physical activity questionnaire) score are consisted of 7 questions regarding frequency of exercise, intensity of exercise, and duration of exercise. Using its automatic report, the results can be calculated as weekly physical activity level (low, intermediate, high). | Week 12 | 
| IPAQ (international physical activity questionnaire) score | IPAQ (international physical activity questionnaire) score are consisted of 7 questions regarding frequency of exercise, intensity of exercise, and duration of exercise. Using its automatic report, the results can be calculated as weekly physical activity level (low, intermediate, high). | Week 24 | 
| number of recordings on personal health record application | number of recordings on personal health record application | Week 12 | 
| number of recordings on personal health record application | number of recordings on personal health record application | Week 24 | 
| Total cholesterol | Total cholesterol (mg/dL) | Week 12 | 
| Total cholesterol | Total cholesterol (mg/dL) | Week 24 | 
| High-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mg/dL) | Week 12 | 
| High-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mg/dL) | Week 24 | 
| Triglycerides | Triglycerides (mg/dL) | Week 12 | 
| Triglycerides | Triglycerides (mg/dL) | Week 24 | 
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (mg/dL) | Week 12 | 
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (mg/dL) | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Physical Activity, Personal health record, Intervention