Type 2 DiabetesNCT02451631
The Mobile Diabetes Mgmt. Study With Type 2 Diabetes
A study testing Traditional care with paper and Health-on G App. + Physician Web in people with Type 2 Diabetes, run by Healthconnect at 3 sites in South Korea.
Trial summary
A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Traditional care with paper and Health-on G App. + Physician Web
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Apr 2015to Mar 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-80 years of age
- Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
- in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
- HbA1c between 7.0% and 10.0%
- ability to understand and use smartphone application
Who cannot join
- type 1 diabetes or patients using insulin pump
- severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary \& peripheral artery within recent 6 months)
- uncontrolled hypertension
- pregnant woman, fertile woman who will not use contraception
- unable to use application during treatment
- taking medication which can affect on glucose level
Show all 9Show fewer
- alcohol abuse or dependency
- over 2.5 times from the upper limit of liver enzyme level
- DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Kyunggi-do
Soo Lim, MD.PhD, limsoo@snu.ac.kr
Soo Lim, MD.PhD.
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Min Kyong Moon, MD.PhD., mkmoon@snu.ac.kr
Min Kyong Moon, MD.PhD
- Recruiting
Seoul National University Hospital
Seoul
Young Min Cho, MD. PhD., ymchomd@snu.ac.kr
Yong Min Cho, MD. PhD
About this study
Official title: A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service in Patients With Type 2 Diabetes Mellitus
A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus
Read the detailed description
The Mobile Diabetes Intervention Study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. The investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of HbA1c over 6 month.
- Conditions
- Type 2 Diabetes
- Being tested
- Traditional care with paper, Health-on G App. + Physician Web
- Keywords
- Mobile Application, Diabetes management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional care with paperOther
Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.
Health-on G App. + Physician WebDevice
Patients use their smart-phone or receive rental phone, and download Health-On G application. Algorithm-based personalized feedback are provided when patients' data are linked to Health-On G Application. Patient self-monitoring blood glucose data from glucometer are transferred to App. automatically by bluetooth, or input manually, check medication regimen, input food intake and exercise, and step counts are linked by Activity tracker. Personalized feedback are instantly provided based on data. Entered data are also connected to web-based physician portal. Physician web portal is provided, where they're able to review their patient's all data. Health-On G is defined as a U-Healthcare medical device consisting of gateway and decision support system.
| Study group | Role | What they receive |
|---|---|---|
| Traditional care | Active comparator | Traditional care with paper(SMBG) and healthcare staff advice in office Receives: Other: Traditional care with paper |
| Health-On G App.+ Physician web portal | Experimental | Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data Receives: Device: Health-on G App. + Physician Web |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%)
Measured: Change from baseline to 24 weeks
Secondary outcomes (4)
Change in HbA1c (%)
Measured: Change from baseline to 12 weeks
Change in SDSCA(Summary of Diabetes Self-Care Activities)
Measured: from baseline to 24 weeks
Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
Measured: from baseline to 24weeks
Change in FBG(Fasting Blood Glucose)
Measured: from baseline to 12weeks and 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthconnect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Young Min Cho, MD.PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451631
- Sponsor's protocol ID
- SB02
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, Kim SY, Yoo SY, Jung HS, Park KS, Ryu JO, Jang HC. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011 Feb;34(2):308-13. doi: 10.2337/dc10-1447.
PubMed 21270188Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.
PubMed 14747232Kim EK, Cho YM. Response to Comment on Kim et al. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care 2019;42:3-9. Diabetes Care. 2019 Jul;42(7):e126. doi: 10.2337/dci19-0021. No abstract available.
PubMed 31221711Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, Jang HC, Park KS, Cho YM. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care. 2019 Jan;42(1):3-9. doi: 10.2337/dc17-2197. Epub 2018 Oct 30.
PubMed 30377185
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02451631
- Acronym / sponsor ID
- SB02
- Conditions
- Type 2 Diabetes
- Keywords
- Mobile Application, Diabetes management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- HealthconnectIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 22 May 2015 (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.
A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus
Detailed description
The Mobile Diabetes Intervention Study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. The investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of HbA1c over 6 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional care | Active comparator | Other: Traditional care with paperTraditional care with paper(SMBG) and healthcare staff advice in office |
| Health-On G App.+ Physician web portal | Experimental | Device: Health-on G App. + Physician WebPatient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20-80 years of age
- Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
- in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
- HbA1c between 7.0% and 10.0%
- ability to understand and use smartphone application
Key exclusion criteria (9 listed)
- type 1 diabetes or patients using insulin pump
- severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary \& peripheral artery within recent 6 months)
- uncontrolled hypertension
- pregnant woman, fertile woman who will not use contraception
- unable to use application during treatment
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 |
|---|---|---|
| Traditional care with paperHealthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper. | Other | Traditional care |
| Health-on G App. + Physician WebPatients use their smart-phone or receive rental phone, and download Health-On G application. Algorithm-based personalized feedback are provided when patients' data are linked to Health-On G Application. Patient self-monitoring blood glucose data from glucometer are transferred to App. automatically by bluetooth, or input manually, check medication regimen, input food intake and exercise, and step counts are linked by Activity tracker. Personalized feedback are instantly provided based on data. Entered data are also connected to web-based physician portal. Physician web portal is provided, where they're able to review their patient's all data. Health-On G is defined as a U-Healthcare medical device consisting of gateway and decision support system. | Device | Health-On G App.+ Physician web portal |
Primary outcome
Change in HbA1c (%)
Time frame: Change from baseline to 24 weeks
4 secondary outcomes
Change in HbA1c (%)
Time frame: Change from baseline to 12 weeks
Change in SDSCA(Summary of Diabetes Self-Care Activities)
Time frame: from baseline to 24 weeks
Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
Time frame: from baseline to 24weeks
Change in FBG(Fasting Blood Glucose)
Time frame: from baseline to 12weeks and 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Background: PubMed 21270188Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, Kim SY, Yoo SY, Jung HS, Park KS, Ryu JO, Jang HC. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011 Feb;34(2):308-13. doi: 10.2337/dc10-1447.
- Background: PubMed 14747232Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.
- Derived from this study: PubMed 31221711Kim EK, Cho YM. Response to Comment on Kim et al. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care 2019;42:3-9. Diabetes Care. 2019 Jul;42(7):e126. doi: 10.2337/dci19-0021. No abstract available.
- Derived from this study: PubMed 30377185Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, Jang HC, Park KS, Cho YM. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care. 2019 Jan;42(1):3-9. doi: 10.2337/dc17-2197. Epub 2018 Oct 30.
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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.
Young Min Cho, MD.PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional care with paper and Health-on G App. + Physician Web in people with Type 2 Diabetes, run by Healthconnect at 3 sites 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 5 inclusion and 9 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Hye Kyung, Hwang (82-2-6292-3426, hkhwang@hconnect.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (%) (time frame: Change from baseline to 24 weeks). 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 NCT02451631, which also lists 4 linked publications.
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 22 May 2015.