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Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01891474
Enrollment
70
Registered
2013-07-03
Start date
2013-08-31
Completion date
2015-03-31
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief 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. 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.

Interventions

DEVICEU-health care

voice inception technique based U-healthcare service

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes * age: 60 \ 85 yrs * HbA1c: 7.0%-11.0% * Basal insulin or premixed insulin user

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Changes of HbA1c24 weeks
Glucose Variability assessed by 3 day SMBG24 weeks

Secondary

MeasureTime frame
Hypoglycemia24 Weeks
Drug Compliance24 Weeks
Self monitoring blood glucose compliance24 Weeks
Target goal of HbA1c (< 7.5%)24 Weeks
Quality of life assessed by SF3624 Weeks
Diabetes Self-Care Activities24 Weeks
Michigan Diabetes Knowledge Test24 Weeks
Weight change24 Weeks
Target goal of HbA1c (< 8.0%)24 Weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026