Clinical trial NCT01891474: Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of HbA1c
timeFrame: 24 weeks
measure: Glucose Variability assessed by 3 day SMBG
timeFrame: 24 weeks
Secondary outcomes:
measure: Target goal of HbA1c (< 7.5%)
timeFrame: 24 Weeks
measure: Target goal of HbA1c (< 8.0%)
timeFrame: 24 Weeks
measure: Hypoglycemia
timeFrame: 24 Weeks
measure: Drug Compliance
timeFrame: 24 Weeks
measure: Self monitoring blood glucose compliance
timeFrame: 24 Weeks
measure: Weight change
timeFrame: 24 Weeks
measure: Quality of life assessed by SF36
timeFrame: 24 Weeks
measure: Diabetes Self-Care Activities
timeFrame: 24 Weeks
measure: Michigan Diabetes Knowledge Test
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.