History of Changes for Study: NCT03407222

Effect of Monitoring of Step Number on Diabetes (PHR)

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Study Record Versions

Version	Submitted Date	Changes
1	January 16, 2018	None (earliest Version on record)
2	February 20, 2018	Outcome Measures, Study Status, Study Description and Study Design
3	January 4, 2019	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	March 21, 2019	Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Eligibility, Study Design and Study Description

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	2017-12-052
Brief Title:	Effect of Monitoring of Step Number on Diabetes (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
Secondary IDs:

Study Status


Record Verification:	January 2019
Overall Status:	Recruiting
Study Start:	April 1, 2018
Primary Completion:	December 30, 2018 [Anticipated]
Study Completion:	October 30, 2019 [Anticipated]

First Submitted:	January 16, 2018
First Submitted that Met QC Criteria:	January 16, 2018
First Posted:	January 23, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	January 4, 2019
Last Update Posted:	January 8, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Samsung Medical Center
Responsible Party:	Principal Investigator Investigator: Jae Hyeon Kim Official Title: Professor Affiliation: Samsung Medical Center
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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 intevention 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.

Conditions


Conditions:	Type 2 Diabetes Mellitus Physical Activity
Keywords:	Type 2 Diabetes Mellitus Physical Activity Personal health record Intervention

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Send text messages which encourage step-by-step increment of daily step count
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	200 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Intervention group Intervention group receives weekly text messages which encourage the increment of daily step count	Text messages Text messages which encourage the increment of daily step count
No Intervention: Control group Control group does not receive text message

Outcome Measures


Primary Outcome Measures:
1.	change in daily step count after 12 weeks of intervention [ Time Frame: Week 12 ] change in daily step count after 12 weeks of intervention
Secondary Outcome Measures:
1.	mean daily step count after 12 weeks of intervention [ Time Frame: Week 12 ] mean daily step count after 12 weeks of intervention
2.	the proportion of patients who reach participant-day during the 12 weeks of intervention [ Time Frame: 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
3.	mean daily step count at Week 24 [ Time Frame: Week 24 ] mean daily step count at Week 24
4.	the proportion of patients who reach participant-day during the Week 13-24 [ Time Frame: Week 24 ] the proportion of patients who reach participant-day during the Week 13-24
5.	the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia [ Time Frame: Week 12 ] the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
6.	the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia [ Time Frame: Week 24 ] the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
7.	HbA1c levels [ Time Frame: Week 12 ] HbA1c levels (%)
8.	HbA1c levels [ Time Frame: Week 24 ] HbA1c levels (%)
9.	Fasting glucose levels [ Time Frame: Week 12 ] Fasting glucose levels (mg/dL)
10.	Fasting glucose levels [ Time Frame: Week 24 ] Fasting glucose levels (mg/dL)
11.	Body weight [ Time Frame: Week 12 ] Body weight (kg)
12.	Body weight [ Time Frame: Week 24 ] Body weight (kg)
13.	Blood pressure [ Time Frame: Week 12 ] Blood pressure (mmHg)
14.	Blood pressure [ Time Frame: Week 24 ] Blood pressure (mmHg)
15.	IPAQ (international physica activity questionnaire) score [ Time Frame: Week 12 ] IPAQ (international physica 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).
16.	IPAQ (international physica activity questionnaire) score [ Time Frame: Week 24 ] IPAQ (international physica 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).
17.	number of recordings on personal health record application [ Time Frame: Week 12 ] number of recordings on personal health record application
18.	number of recordings on personal health record application [ Time Frame: Week 24 ] number of recordings on personal health record application
19.	Total cholesterol [ Time Frame: Week 12 ] Total cholesterol (mg/dL)
20.	Total cholesterol [ Time Frame: Week 24 ] Total cholesterol (mg/dL)
21.	High-density lipoprotein cholesterol [ Time Frame: Week 12 ] High-density lipoprotein cholesterol (mg/dL)
22.	High-density lipoprotein cholesterol [ Time Frame: Week 24 ] High-density lipoprotein cholesterol (mg/dL)
23.	Triglycerides [ Time Frame: Week 12 ] Triglycerides (mg/dL)
24.	Triglycerides [ Time Frame: Week 24 ] Triglycerides (mg/dL)
25.	low-density lipoprotein cholesterol [ Time Frame: Week 12 ] low-density lipoprotein cholesterol (mg/dL)
26.	low-density lipoprotein cholesterol [ Time Frame: Week 24 ] low-density lipoprotein cholesterol (mg/dL)

Eligibility


Minimum Age:	20 Years
Maximum Age:	69 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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 Patietns 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

Contacts/Locations


Central Contact Person:	Jae Hyeon Kim, MD PhD Telephone: 82-2-3410-1580 Email: jaehyeonmd.kim@samsung.com
Central Contact Backup:	Gyuri Kim, MD PhD Telephone: 82-2-3410-1580 Email: gyuri5.kim@samsung.com
Locations:	Korea, Republic of
	Samsung Medical Center [Recruiting] Seoul, Korea, Republic of, 135-710 Contact:Contact: Jae Hyeon Kim, M.D.,Ph. D 82-2-3410-1580 jaehyeonmd.kim@samsung.com

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: