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Status unknownNCT03407222PHRUpdated Mar 25, 2019

Effect of Monitoring of Step Number on Diabetes

An interventional study of Text messages in Type 2 Diabetes Mellitus and Physical Activity, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Physical Activity

Keywords

  • Type 2 Diabetes Mellitus
  • Physical Activity
  • Personal health record
  • Intervention
03

Who can participate

Ages eligible
20 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Intervention group

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

    Other: Text messages

  • No intervention
    Control group

    Control group does not receive text message

Interventions

  • OtherText messages

    Text messages which encourage the increment of daily step count

05

What researchers measure

Primary outcomes

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

    change in daily step count after 12 weeks of intervention

    Time frame: Week 12

Secondary outcomes

  1. mean daily step count after 12 weeks of intervention

    mean daily step count after 12 weeks of intervention

    Time frame: Week 12

  2. 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

    Time frame: Week 12

  3. mean daily step count at Week 24

    mean daily step count at Week 24

    Time frame: Week 24

  4. 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

    Time frame: Week 24

  5. the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia

    the proportion of patients whose HbA1c levels \<6.5% without severe hypoglycemia

    Time frame: Week 12

  6. the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia

    the proportion of patients whose HbA1c levels \<6.5% without severe hypoglycemia

    Time frame: Week 24

  7. HbA1c levels

    HbA1c levels (%)

    Time frame: Week 12

  8. HbA1c levels

    HbA1c levels (%)

    Time frame: Week 24

  9. Fasting glucose levels

    Fasting glucose levels (mg/dL)

    Time frame: Week 12

  10. Fasting glucose levels

    Fasting glucose levels (mg/dL)

    Time frame: Week 24

  11. Body weight

    Body weight (kg)

    Time frame: Week 12

  12. Body weight

    Body weight (kg)

    Time frame: Week 24

  13. Blood pressure

    Blood pressure (mmHg)

    Time frame: Week 12

  14. Blood pressure

    Blood pressure (mmHg)

    Time frame: Week 24

  15. 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).

    Time frame: Week 12

  16. 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).

    Time frame: Week 24

  17. number of recordings on personal health record application

    number of recordings on personal health record application

    Time frame: Week 12

  18. number of recordings on personal health record application

    number of recordings on personal health record application

    Time frame: Week 24

  19. Total cholesterol

    Total cholesterol (mg/dL)

    Time frame: Week 12

  20. Total cholesterol

    Total cholesterol (mg/dL)

    Time frame: Week 24

  21. High-density lipoprotein cholesterol

    High-density lipoprotein cholesterol (mg/dL)

    Time frame: Week 12

  22. High-density lipoprotein cholesterol

    High-density lipoprotein cholesterol (mg/dL)

    Time frame: Week 24

  23. Triglycerides

    Triglycerides (mg/dL)

    Time frame: Week 12

  24. Triglycerides

    Triglycerides (mg/dL)

    Time frame: Week 24

  25. low-density lipoprotein cholesterol

    low-density lipoprotein cholesterol (mg/dL)

    Time frame: Week 12

  26. low-density lipoprotein cholesterol

    low-density lipoprotein cholesterol (mg/dL)

    Time frame: Week 24

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407222
Lead sponsor
Samsung Medical Center
Responsible party
Jae Hyeon Kim (Professor, Samsung Medical Center) — Principal investigator
First posted
Jan 23, 2018
Start date
Apr 1, 2018
Primary completion
Sep 30, 2019 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
Mar 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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