Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
- Conditions
- Type 2 Diabetes
- Interventions
- Procedure: Telemonitoring groupProcedure: Telemonitoring & TelemedicineOther: SMBG
- Registration Number
- NCT01345435
- Lead Sponsor
- CHANGHEE LEE
- Brief Summary
A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.
- Detailed Description
1. Objectives : To evaluate superiority in the Hemoglobin A1C -lowering effect of Smart Care Service compared to the conventional treatment in patients with type 2 diabetes.
2. Test and control group
* Control group : The subject group who is receiving any conventional treatment (hospital visit).
* Test groups
* Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
* Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony
3. Target Subject: Type II diabetes patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
- More than 20 years of age and under 60 years of age
- Patients who are able to receive outpatient treatment with type II diabetes mellitus.
- If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
- Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
- Patients who are able to understand the purpose of this trial and to read and write.
- Patients who are able to use the Smart Care PC for this study.
- Patients who have wired/wireless internet access at home.
- Patients who participate voluntarily and sign the informed consent.
- Patients with type I diabetes mellitus
- Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
- Patients who take medicines which can significantly affect glycemic control.
- Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
- Patients currently being hospitalized or planning to hospitalize during the study period.
- Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
- Pregnant or lactating women.
- Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
- Patients with uncontrolled chronic lung disease.
- Patients with known history of alcoholism, mental illness, or drug dependency.
- Patients who have cognitive disorder or psychiatric problems
- Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
- Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring group Telemonitoring group * A Smart Care PC, blood glucose meter and body composition analyzer will be provided * transmitting the results to the Smart Care Server via Smart Care PC * At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management Telemonitoring & Telemedicine group Telemonitoring & Telemedicine * A Smart Care PC, blood glucose meter and body composition analyzer will be provided * transmitting the results to the Smart Care Server via Smart Care PC * At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management * taking telemedicine through video telephone instead of visiting hospital Control group SMBG * Blood glucose meter and body composition analyzer will be provided * Self-monitoring Blood Glucose (SMBG)
- Primary Outcome Measures
Name Time Method Changes in Hemoglobin A1c 0 and 24 weeks Changes in Hemoglobin A1c from baseline to 24 weeks visit.
Reduce Hemoglobin A1c after study
- Secondary Outcome Measures
Name Time Method Changes in lipid profile 0 and 24 weeks Changes in lipid profile from baseline to 24 weeks visit
Maintains normal lipid profileMedication compliance up to 24 weeks * Patients diary will be recorded and medication compliance will be calculated by calculating the number of days administered Insulin or Oral Hypoglycemic Agents during the study
* Drugs compliance = the number of days administered antihypertensive drugs / participated period in this study \* 100%Changes in FBS (Fasting blood sugar) 0 and 24 weeks Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit
Maintains FBS within the normal rangeSMBG(Self-monitoring of blood glucose) compliance up to 24 weeks measurement of Self-monitoring of blood glucose
Percentage of subjects who achieved goal Hemoglobin A1c 0 and 24 weeks Goal Hemoglobin A1c \<7%
Assessment of patients' satisfaction 24 weeks Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable
Changes in body mass index (BMI) 0 and 24 weeks Reduction of body mass index
- BMI=Body weight (kg)/Height2(m)Changes in body weight 0 and 24 weeks Reduce body weight from baseline to 24 weeks visit
Trial Locations
- Locations (4)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Yonsei University Health System
🇰🇷Seoul, Korea, Republic of