Clinical trial NCT01345435: Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: telemonitoring
usual care
telemedicine
telehealth
home care
Health Care Quality
Access
Evaluation
Lead sponsor: LG Electronics Inc.
Sponsor class: INDUSTRY
Collaborators: name: LG Electronics Inc.
name: Purdue University
First posted: 2011-05-02
Enrollment: 417
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

1. More than 20 years of age and under 60 years of age
2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.
3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
5. Patients who are able to understand the purpose of this trial and to read and write.
6. Patients who are able to use the Smart Care PC for this study.
7. Patients who have wired/wireless internet access at home.
8. Patients who participate voluntarily and sign the informed consent.

Exclusion Criteria:

1. Patients with type I diabetes mellitus
2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
3. Patients who take medicines which can significantly affect glycemic control.
4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
5. Patients currently being hospitalized or planning to hospitalize during the study period.
6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
7. Pregnant or lactating women.
8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
9. Patients with uncontrolled chronic lung disease.
10. Patients with known history of alcoholism, mental illness, or drug dependency.
11. Patients who have cognitive disorder or psychiatric problems
12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
13. 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.

Primary outcomes:
measure: Changes in Hemoglobin A1c
timeFrame: 0 and 24 weeks
Secondary outcomes:
measure: Changes in FBS (Fasting blood sugar)
timeFrame: 0 and 24 weeks
measure: Changes in lipid profile
timeFrame: 0 and 24 weeks
measure: Percentage of subjects who achieved goal Hemoglobin A1c
timeFrame: 0 and 24 weeks
measure: Changes in body mass index (BMI)
timeFrame: 0 and 24 weeks
measure: SMBG(Self-monitoring of blood glucose) compliance
timeFrame: up to 24 weeks
measure: Changes in body weight
timeFrame: 0 and 24 weeks
measure: Assessment of patients' satisfaction
timeFrame: 24 weeks
measure: Medication compliance
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
Study officials:
affiliation: Kyungpook National University Hospital
name: In Kyu Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: