Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 7:57 AM
Study NCT ID:
NCT01345435
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Sponsor:
CHANGHEE LEE
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Smart-DM
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: