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Type 2 Diabetes MellitusPHRNCT03407222

Effect of Monitoring of Step Number on Diabetes

A study testing Text messages in people with Type 2 Diabetes Mellitus and Physical Activity, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 69 years
Conditions the study is for
Type 2 Diabetes Mellitus, Physical Activity
What is being tested?
Text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Korea
Study dates
1 Apr 2018to 30 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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

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.

Being tested
Text messages
Keywords
Type 2 Diabetes Mellitus, Physical Activity, Personal health record, Intervention
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text messagesOther

    Text messages which encourage the increment of daily step count

Study groups in NCT03407222
Study groupRoleWhat they receive
Intervention groupActive comparatorIntervention group receives weekly text messages which encourage the increment of daily step count
Receives: Other: Text messages
Control groupNo interventionControl group does not receive text message

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    change in daily step count after 12 weeks of intervention

    Measured: Week 12

Secondary outcomes (26)

  1. mean daily step count after 12 weeks of intervention

    mean daily step count after 12 weeks of intervention

    Measured: 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

    Measured: Week 12

  3. mean daily step count at Week 24

    mean daily step count at Week 24

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 24

  7. HbA1c levels

    HbA1c levels (%)

    Measured: Week 12

  8. HbA1c levels

    HbA1c levels (%)

    Measured: Week 24

  9. Fasting glucose levels

    Fasting glucose levels (mg/dL)

    Measured: Week 12

  10. Fasting glucose levels

    Fasting glucose levels (mg/dL)

    Measured: Week 24

  11. Body weight

    Body weight (kg)

    Measured: Week 12

  12. Body weight

    Body weight (kg)

    Measured: Week 24

  13. Blood pressure

    Blood pressure (mmHg)

    Measured: Week 12

  14. Blood pressure

    Blood pressure (mmHg)

    Measured: 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).

    Measured: 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).

    Measured: Week 24

  17. number of recordings on personal health record application

    number of recordings on personal health record application

    Measured: Week 12

  18. number of recordings on personal health record application

    number of recordings on personal health record application

    Measured: Week 24

  19. Total cholesterol

    Total cholesterol (mg/dL)

    Measured: Week 12

  20. Total cholesterol

    Total cholesterol (mg/dL)

    Measured: Week 24

  21. High-density lipoprotein cholesterol

    High-density lipoprotein cholesterol (mg/dL)

    Measured: Week 12

  22. High-density lipoprotein cholesterol

    High-density lipoprotein cholesterol (mg/dL)

    Measured: Week 24

  23. Triglycerides

    Triglycerides (mg/dL)

    Measured: Week 12

  24. Triglycerides

    Triglycerides (mg/dL)

    Measured: Week 24

  25. low-density lipoprotein cholesterol

    low-density lipoprotein cholesterol (mg/dL)

    Measured: Week 12

  26. low-density lipoprotein cholesterol

    low-density lipoprotein cholesterol (mg/dL)

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Apr 2018
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion30 Nov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Send text messages which encourage step-by-step increment of daily step count
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03407222
Sponsor's protocol ID
2017-12-052
Acronym
PHR
Status last verified
Mar 2019
First submitted
16 Jan 2018
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim G, Kim S, Lee YB, Jin SM, Hur KY, Kim JH. A randomized controlled trial of an app-based intervention on physical activity and glycemic control in people with type 2 diabetes. BMC Med. 2024 May 1;22(1):185. doi: 10.1186/s12916-024-03408-w.

    PubMed 38693528

Questions about this trial

What is this clinical trial studying?

A study testing Text messages in people with Type 2 Diabetes Mellitus and Physical Activity, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in daily step count after 12 weeks of intervention (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.

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