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NCT Number: NCT01891474

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

U-health care

Device

voice inception technique based U-healthcare service

Other names: U-health care group

Primary outcomes

  1. Changes of HbA1c

    Time frame: 24 weeks

  2. Glucose Variability assessed by 3 day SMBG

    Time frame: 24 weeks

Secondary outcomes

  1. Target goal of HbA1c (< 7.5%)

    Time frame: 24 Weeks

  2. Target goal of HbA1c (< 8.0%)

    Time frame: 24 Weeks

  3. Hypoglycemia

    Time frame: 24 Weeks

  4. Drug Compliance

    Time frame: 24 Weeks

  5. Self monitoring blood glucose compliance

    Time frame: 24 Weeks

  6. Weight change

    Time frame: 24 Weeks

  7. Quality of life assessed by SF36

    Time frame: 24 Weeks

  8. Diabetes Self-Care Activities

    Time frame: 24 Weeks

  9. Michigan Diabetes Knowledge Test

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2013
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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