NCT03407222

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

January 16, 2018

Last Update Submit

March 21, 2019

Conditions

Type 2 Diabetes MellitusPhysical Activity

Keywords

Type 2 Diabetes MellitusPhysical ActivityPersonal health recordIntervention

Outcome Measures

Primary Outcomes (1)

  • change in daily step count after 12 weeks of intervention

    change in daily step count after 12 weeks of intervention

    Week 12

Secondary Outcomes (26)

  • mean daily step count after 12 weeks of intervention

    Week 12

  • the proportion of patients who reach participant-day during the 12 weeks of intervention

    Week 12

  • mean daily step count at Week 24

    Week 24

  • the proportion of patients who reach participant-day during the Week 13-24

    Week 24

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

    Week 12

  • +21 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Other: Text messages

Control group

NO INTERVENTION

Control group does not receive text message

Interventions

Text messagesOTHER

Text messages which encourage the increment of daily step count

Intervention group

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 38693528DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Send text messages which encourage step-by-step increment of daily step count
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

April 1, 2018

Primary Completion

September 30, 2019

Study Completion

November 30, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)