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Completed

NCT Number: NCT01137058

Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.

To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.

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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, South Korea

About this study

Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.

Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.

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: 6.5%-11.0%
  • duration of diabetes: less than 30 years
  • BMI: 20-35

Exclusion criteria

  • systemic corticosteroid administered within previous 6 months
  • history of myocardial ischemia
  • Heart failure, NYHA Class II-IV
  • Thyroid disease with abnormal TFT
  • Anti-obesity drugs or slimming products within previous 3 months

Treatment and study plan

U-healthcare service

Device

Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.

Other names: U-healthcare group

SMBG group

Device

Glucose control with self monitoring of blood glucose.

Primary outcomes

  1. Target goal of HbA1c (< 7.0%) without hypoglycemia

    Time frame: 24 weeks

    Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia

Secondary outcomes

  1. quality of life

    Time frame: 24 weeks

  2. amount of exercise

    Time frame: 24 weeks

  3. Body mass index (BMI) changes

    Time frame: Body mass index

    Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2010
Registry last updated
May 28, 2014

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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