Effect of Monitoring of Step Number on Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— PHR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03407222
• Other study ID #: 2017-12-052
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Physical Activity
• Type 2 Diabetes Mellitus

Intervention

Other:
• Text messages
Text messages which encourage the increment of daily step count

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in daily step count after 12 weeks of intervention	change in daily step count after 12 weeks of intervention	Week 12
Secondary	mean daily step count after 12 weeks of intervention	mean daily step count after 12 weeks of intervention	Week 12
Secondary	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
Secondary	mean daily step count at Week 24	mean daily step count at Week 24	Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	HbA1c levels	HbA1c levels (%)	Week 12
Secondary	HbA1c levels	HbA1c levels (%)	Week 24
Secondary	Fasting glucose levels	Fasting glucose levels (mg/dL)	Week 12
Secondary	Fasting glucose levels	Fasting glucose levels (mg/dL)	Week 24
Secondary	Body weight	Body weight (kg)	Week 12
Secondary	Body weight	Body weight (kg)	Week 24
Secondary	Blood pressure	Blood pressure (mmHg)	Week 12
Secondary	Blood pressure	Blood pressure (mmHg)	Week 24
Secondary	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
Secondary	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
Secondary	number of recordings on personal health record application	number of recordings on personal health record application	Week 12
Secondary	number of recordings on personal health record application	number of recordings on personal health record application	Week 24
Secondary	Total cholesterol	Total cholesterol (mg/dL)	Week 12
Secondary	Total cholesterol	Total cholesterol (mg/dL)	Week 24
Secondary	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol (mg/dL)	Week 12
Secondary	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol (mg/dL)	Week 24
Secondary	Triglycerides	Triglycerides (mg/dL)	Week 12
Secondary	Triglycerides	Triglycerides (mg/dL)	Week 24
Secondary	low-density lipoprotein cholesterol	low-density lipoprotein cholesterol (mg/dL)	Week 12
Secondary	low-density lipoprotein cholesterol	low-density lipoprotein cholesterol (mg/dL)	Week 24