Effect of Monitoring of Step Number on Diabetes

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Physical Activity
• Interventions: Other: Text messages

• Registration Number: NCT03407222
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-23
• Study Start: 2018-04-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25
• Primary Completion: 2019-09-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Text messages	Intervention group receives weekly text messages which encourage the increment of daily step count

Primary Outcome Measures

Name	Time	Method
change in daily step count after 12 weeks of intervention	Week 12	change in daily step count after 12 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia	Week 24	the proportion of patients whose HbA1c levels \<6.5% without severe hypoglycemia
High-density lipoprotein cholesterol	Week 24	High-density lipoprotein cholesterol (mg/dL)
HbA1c levels	Week 24	HbA1c levels (%)
Fasting glucose levels	Week 24	Fasting glucose levels (mg/dL)
IPAQ (international physical activity questionnaire) score	Week 24	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).
low-density lipoprotein cholesterol	Week 24	low-density lipoprotein cholesterol (mg/dL)
mean daily step count after 12 weeks of intervention	Week 12	mean daily step count after 12 weeks of intervention
Body weight	Week 24	Body weight (kg)
Blood pressure	Week 24	Blood pressure (mmHg)
Triglycerides	Week 24	Triglycerides (mg/dL)
the proportion of patients who reach participant-day during the 12 weeks of intervention	Week 12	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
mean daily step count at Week 24	Week 24	mean daily step count at Week 24
the proportion of patients who reach participant-day during the Week 13-24	Week 24	the proportion of patients who reach participant-day during the Week 13-24
number of recordings on personal health record application	Week 24	number of recordings on personal health record application
Total cholesterol	Week 24	Total cholesterol (mg/dL)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of