Effect of Monitoring of Step Number on Diabetes (PHR)

Samsung Medical Center

Status

Unknown

Conditions

Physical Activity

Type 2 Diabetes Mellitus

Treatments

Other: Text messages

Study type

Interventional

Funder types

Other

Identifiers

NCT03407222

2017-12-052

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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