DiabetesNCT01891474
Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
A study testing U-health care in people with Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- U-health care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Mar 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- age: 60 ~ 85 yrs
- HbA1c: 7.0%-11.0%
- Basal insulin or premixed insulin user
Who cannot join
- Type 1 diabetes
- short acting insulin or insulin pump user
- systemic corticosteroid administered within previous 6 months
- history of myocardial ischemia
- Heart failure, New York Heart Association (NYHA) Class II-IV
- Thyroid disease with abnormal thyroid function test
- Anti-obesity drugs or slimming products within previous 3 months
- severe liver or kidney disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: An Open, Parallel-group, Randomized, Interventional Study to Compare the Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices.
To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).
Read the detailed description
Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. Nowadays, various methods are tried to find the most effective and easiest way for supplying U-health care.
Here, researchers are going to investigate the efficacy and safety of voice inception technique based U-healthcare service.
- Conditions
- Diabetes
- Being tested
- U-health care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-health careDevice
Also called U-health care group
voice inception technique based U-healthcare service
| Study group | Role | What they receive |
|---|---|---|
| U-health care | Experimental | voice inception technique based U-healthcare service Receives: Device: U-health care |
| control | No intervention | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of HbA1c
Measured: 24 weeks
Glucose Variability assessed by 3 day SMBG
Measured: 24 weeks
Secondary outcomes (9)
Target goal of HbA1c (< 7.5%)
Measured: 24 Weeks
Target goal of HbA1c (< 8.0%)
Measured: 24 Weeks
Hypoglycemia
Measured: 24 Weeks
Drug Compliance
Measured: 24 Weeks
Self monitoring blood glucose compliance
Measured: 24 Weeks
Weight change
Measured: 24 Weeks
Quality of life assessed by SF36
Measured: 24 Weeks
Diabetes Self-Care Activities
Measured: 24 Weeks
Michigan Diabetes Knowledge Test
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionMar 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 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, MPH, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891474
- Sponsor's protocol ID
- SNUBH_Uhealth2
- Status last verified
- Oct 2015
- First submitted
- 28 Jun 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KM, Park KS, Lee HJ, Lee YH, Bae JS, Lee YJ, Choi SH, Jang HC, Lim S. Efficacy of a New Medical Information system, Ubiquitous Healthcare Service with Voice Inception Technique in Elderly Diabetic Patients. Sci Rep. 2015 Dec 11;5:18214. doi: 10.1038/srep18214.
PubMed 26658492
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Parallel-group, Randomized, Interventional Study to Compare the Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01891474
- Acronym / sponsor ID
- SNUBH_Uhealth2
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Jul 2013 (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.
Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices.
To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).
Detailed description
Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. Nowadays, various methods are tried to find the most effective and easiest way for supplying U-health care.
Here, researchers are going to investigate the efficacy and safety of voice inception technique based U-healthcare service.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U-health care | Experimental | Device: U-health carevoice inception technique based U-healthcare service |
| control | No intervention | –conventional treatment |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- age: 60 ~ 85 yrs
- HbA1c: 7.0%-11.0%
- Basal insulin or premixed insulin user
Key exclusion criteria (8 listed)
- Type 1 diabetes
- short acting insulin or insulin pump user
- systemic corticosteroid administered within previous 6 months
- history of myocardial ischemia
- Heart failure, New York Heart Association (NYHA) Class II-IV
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 |
|---|---|---|
| U-health careAlso: U-health care groupvoice inception technique based U-healthcare service | Device | U-health care |
Primary outcome
Changes of HbA1c
Time frame: 24 weeks
Glucose Variability assessed by 3 day SMBG
Time frame: 24 weeks
9 secondary outcomes
Target goal of HbA1c (< 7.5%)
Time frame: 24 Weeks
Target goal of HbA1c (< 8.0%)
Time frame: 24 Weeks
Hypoglycemia
Time frame: 24 Weeks
Drug Compliance
Time frame: 24 Weeks
Self monitoring blood glucose compliance
Time frame: 24 Weeks
Weight change
Time frame: 24 Weeks
Quality of life assessed by SF36
Time frame: 24 Weeks
Diabetes Self-Care Activities
Time frame: 24 Weeks
Michigan Diabetes Knowledge Test
Time frame: 24 Weeks
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 27 Oct 2015.
- Derived from this study: PubMed 26658492Kim KM, Park KS, Lee HJ, Lee YH, Bae JS, Lee YJ, Choi SH, Jang HC, Lim S. Efficacy of a New Medical Information system, Ubiquitous Healthcare Service with Voice Inception Technique in Elderly Diabetic Patients. Sci Rep. 2015 Dec 11;5:18214. doi: 10.1038/srep18214.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Soo Lim, MD, MPH, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-health care in people with Diabetes, run by Seoul National University Bundang Hospital 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 4 inclusion and 8 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 27 Oct 2015. 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?
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?
Changes of HbA1c (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01891474, 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 27 Oct 2015.