NCT03033407

Brief Summary

The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2014

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

January 18, 2017

Last Update Submit

January 24, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • glycated hemoglobin levels

    at 6 months

Secondary Outcomes (6)

  • change in glycated hemoglobin levels within each group

    between baseline and 6 months

  • change in body mass index within each group

    between baseline and 6 months

  • change in low-density lipoprotein cholesterol within each group

    between baseline and 6 months

  • change in high-density lipoprotein cholesterol within each group

    between baseline and 6 months

  • change in triglyceride within each group

    between baseline and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention-Maintenance group

EXPERIMENTAL

Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. This study was divided into two phases. In six-month phase 1 study, the participants in I-M group received tailored mobile coaching. And during the second half six-month phase 2 study, they could receive only regular information messages without individualized coaching.

Other: Tailored mobile coaching messages

Control-Intervention group

ACTIVE COMPARATOR

Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. In six-month phase 1 study, the participants in Control-Intervention group maintained usual care for diabetes. During the second half six-month phase 2 study, they received tailored mobile coaching.

Other: Tailored mobile coaching messages

Interventions

Tailored mobile coaching messagesOTHER

Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.

Control-Intervention groupIntervention-Maintenance group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean policyholders with type 2 diabetes;
  • Aged ≥ 19 years;
  • Smartphone users;
  • Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.

You may not qualify if:

  • Currently had serious concomitant disease other than diabetes;
  • Had admission histories due to malignancy, myocardial infarction, cerebral infarction, or organ transplantation;
  • Pregnant or had plan for pregnancy within 6 months;
  • Planned for attending other clinical;
  • Illiteracy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lee MK, Lee DY, Ahn HY, Park CY. A Novel User Utility Score for Diabetes Management Using Tailored Mobile Coaching: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 24;9(2):e17573. doi: 10.2196/17573.

    PMID: 33625363DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It was open label study.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 26, 2017

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share