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Effect of Monitoring of Step Number on Diabetes (PHR)

Primary Purpose

Type 2 Diabetes Mellitus, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Text messages
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Physical Activity, Personal health record, Intervention

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Control group does not receive text message

Outcomes

Primary Outcome Measures

change in daily step count after 12 weeks of intervention
change in daily step count after 12 weeks of intervention

Secondary Outcome Measures

mean daily step count after 12 weeks of intervention
mean daily step count after 12 weeks of intervention
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
mean daily step count at Week 24
mean daily step count at 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
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
HbA1c levels
HbA1c levels (%)
HbA1c levels
HbA1c levels (%)
Fasting glucose levels
Fasting glucose levels (mg/dL)
Fasting glucose levels
Fasting glucose levels (mg/dL)
Body weight
Body weight (kg)
Body weight
Body weight (kg)
Blood pressure
Blood pressure (mmHg)
Blood pressure
Blood pressure (mmHg)
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).
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).
number of recordings on personal health record application
number of recordings on personal health record application
number of recordings on personal health record application
number of recordings on personal health record application
Total cholesterol
Total cholesterol (mg/dL)
Total cholesterol
Total cholesterol (mg/dL)
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mg/dL)
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mg/dL)
Triglycerides
Triglycerides (mg/dL)
Triglycerides
Triglycerides (mg/dL)
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol (mg/dL)
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol (mg/dL)

Full Information

First Posted
January 16, 2018
Last Updated
March 21, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03407222
Brief Title
Effect of Monitoring of Step Number on Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Physical Activity
Keywords
Type 2 Diabetes Mellitus, Physical Activity, Personal health record, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Send text messages which encourage step-by-step increment of daily step count
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Intervention group receives weekly text messages which encourage the increment of daily step count
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group does not receive text message
Intervention Type
Other
Intervention Name(s)
Text messages
Intervention Description
Text messages which encourage the increment of daily step count
Primary Outcome Measure Information:
Title
change in daily step count after 12 weeks of intervention
Description
change in daily step count after 12 weeks of intervention
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
mean daily step count after 12 weeks of intervention
Description
mean daily step count after 12 weeks of intervention
Time Frame
Week 12
Title
the proportion of patients who reach participant-day during the 12 weeks of intervention
Description
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
Time Frame
Week 12
Title
mean daily step count at Week 24
Description
mean daily step count at Week 24
Time Frame
Week 24
Title
the proportion of patients who reach participant-day during the Week 13-24
Description
the proportion of patients who reach participant-day during the Week 13-24
Time Frame
Week 24
Title
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
Description
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
Time Frame
Week 12
Title
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
Description
the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
Time Frame
Week 24
Title
HbA1c levels
Description
HbA1c levels (%)
Time Frame
Week 12
Title
HbA1c levels
Description
HbA1c levels (%)
Time Frame
Week 24
Title
Fasting glucose levels
Description
Fasting glucose levels (mg/dL)
Time Frame
Week 12
Title
Fasting glucose levels
Description
Fasting glucose levels (mg/dL)
Time Frame
Week 24
Title
Body weight
Description
Body weight (kg)
Time Frame
Week 12
Title
Body weight
Description
Body weight (kg)
Time Frame
Week 24
Title
Blood pressure
Description
Blood pressure (mmHg)
Time Frame
Week 12
Title
Blood pressure
Description
Blood pressure (mmHg)
Time Frame
Week 24
Title
IPAQ (international physical activity questionnaire) score
Description
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).
Time Frame
Week 12
Title
IPAQ (international physical activity questionnaire) score
Description
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).
Time Frame
Week 24
Title
number of recordings on personal health record application
Description
number of recordings on personal health record application
Time Frame
Week 12
Title
number of recordings on personal health record application
Description
number of recordings on personal health record application
Time Frame
Week 24
Title
Total cholesterol
Description
Total cholesterol (mg/dL)
Time Frame
Week 12
Title
Total cholesterol
Description
Total cholesterol (mg/dL)
Time Frame
Week 24
Title
High-density lipoprotein cholesterol
Description
High-density lipoprotein cholesterol (mg/dL)
Time Frame
Week 12
Title
High-density lipoprotein cholesterol
Description
High-density lipoprotein cholesterol (mg/dL)
Time Frame
Week 24
Title
Triglycerides
Description
Triglycerides (mg/dL)
Time Frame
Week 12
Title
Triglycerides
Description
Triglycerides (mg/dL)
Time Frame
Week 24
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol (mg/dL)
Time Frame
Week 12
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol (mg/dL)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Monitoring of Step Number on Diabetes

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