Clinical trial NCT03407222: Effect of Monitoring of Step Number on Diabetes
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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Physical Activity
Keywords: Type 2 Diabetes Mellitus
Physical Activity
Personal health record
Intervention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Send text messages which encourage step-by-step increment of daily step count
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in daily step count after 12 weeks of intervention
timeFrame: Week 12
Secondary outcomes:
measure: mean daily step count after 12 weeks of intervention
timeFrame: Week 12
measure: the proportion of patients who reach participant-day during the 12 weeks of intervention
timeFrame: Week 12
measure: mean daily step count at Week 24
timeFrame: Week 24
measure: the proportion of patients who reach participant-day during the Week 13-24
timeFrame: Week 24
measure: the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
timeFrame: Week 12
measure: the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia
timeFrame: Week 24
measure: HbA1c levels
timeFrame: Week 12
measure: HbA1c levels
timeFrame: Week 24
measure: Fasting glucose levels
timeFrame: Week 12
measure: Fasting glucose levels
timeFrame: Week 24
measure: Body weight
timeFrame: Week 12
measure: Body weight
timeFrame: Week 24
measure: Blood pressure
timeFrame: Week 12
measure: Blood pressure
timeFrame: Week 24
measure: IPAQ (international physical activity questionnaire) score
timeFrame: Week 12
measure: IPAQ (international physical activity questionnaire) score
timeFrame: Week 24
measure: number of recordings on personal health record application
timeFrame: Week 12
measure: number of recordings on personal health record application
timeFrame: Week 24
measure: Total cholesterol
timeFrame: Week 12
measure: Total cholesterol
timeFrame: Week 24
measure: High-density lipoprotein cholesterol
timeFrame: Week 12
measure: High-density lipoprotein cholesterol
timeFrame: Week 24
measure: Triglycerides
timeFrame: Week 12
measure: Triglycerides
timeFrame: Week 24
measure: low-density lipoprotein cholesterol
timeFrame: Week 12
measure: low-density lipoprotein cholesterol
timeFrame: Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: