Diabetes MellitusNCT03033407
A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System
A study testing Tailored mobile coaching messages in people with Diabetes Mellitus, run by Kangbuk Samsung Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Tailored mobile coaching messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean policyholders with type 2 diabetes;
- Aged ≥ 19 years;
- Smartphone users;
- Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.
Who cannot join
- 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.
About this study
Official title: A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of the S-Diabetes Care Program Based on Ubiquitous Healthcare System in Patients With Type 2 Diabetes
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.
Read the detailed description
The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering the fact that complications of diabetes result in greater expenditure and reduced productivity is a socioeconomic concern, adequate glycemic control is important not only as individual health problem but also as challenge to healthcare systems worldwide. To support patients' behavior change efforts, including healthy lifestyle choices, disease self-management, and prevention of diabetes complication, multifaceted professional interventions are needed. Ubiquitous healthcare based on information and communication technology is one of these approaches.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Tailored mobile coaching messages
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Tailored mobile coaching messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin levels
Measured: at 6 months
Secondary outcomes (6)
change in glycated hemoglobin levels within each group
Measured: between baseline and 6 months
change in body mass index within each group
Measured: between baseline and 6 months
change in low-density lipoprotein cholesterol within each group
Measured: between baseline and 6 months
change in high-density lipoprotein cholesterol within each group
Measured: between baseline and 6 months
change in triglyceride within each group
Measured: between baseline and 6 months
change in blood pressure within each group
Measured: between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol-Young Park, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033407
- Sponsor's protocol ID
- KBSMC 2014-09-021
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 33625363
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of the S-Diabetes Care Program Based on Ubiquitous Healthcare System in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03033407
- Acronym / sponsor ID
- KBSMC 2014-09-021
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering the fact that complications of diabetes result in greater expenditure and reduced productivity is a socioeconomic concern, adequate glycemic control is important not only as individual health problem but also as challenge to healthcare systems worldwide. To support patients' behavior change efforts, including healthy lifestyle choices, disease self-management, and prevention of diabetes complication, multifaceted professional interventions are needed. Ubiquitous healthcare based on information and communication technology is one of these approaches.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Maintenance group | Experimental | Other: Tailored mobile coaching messagesIntervention 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. |
| Control-Intervention group | Active comparator | Other: Tailored mobile coaching messagesIntervention 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Korean policyholders with type 2 diabetes;
- Aged ≥ 19 years;
- Smartphone users;
- Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored mobile coaching messagesIntervention 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. | Other | Control-Intervention group, Intervention-Maintenance group |
Primary outcome
glycated hemoglobin levels
Time frame: at 6 months
6 secondary outcomes
change in glycated hemoglobin levels within each group
Time frame: between baseline and 6 months
change in body mass index within each group
Time frame: between baseline and 6 months
change in low-density lipoprotein cholesterol within each group
Time frame: between baseline and 6 months
change in high-density lipoprotein cholesterol within each group
Time frame: between baseline and 6 months
change in triglyceride within each group
Time frame: between baseline and 6 months
change in blood pressure within each group
Time frame: between baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 33625363Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored mobile coaching messages in people with Diabetes Mellitus, run by Kangbuk Samsung Hospital.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glycated hemoglobin levels (time frame: at 6 months). 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 NCT03033407, 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 26 Jan 2017.