Effect of Monitoring of Step Number on Diabetes (PHR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Text messages

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Intervention; Type 2 Diabetes Mellitus; Personal health record
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017-12-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No