Trials / Completed
CompletedNCT01498367
Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece
Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Regional Health Authority of Sterea & Thessaly · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.
Detailed description
The present study aims to examine the clinical and financial effects and the patients' perception and satisfaction of home telemedicine support system for diabetes management versus standard (usual) care. In the intervention group the patients will be provided with a blood glucose meter and a mobile phone and their data will be transferred via the mobile to the regional database and will be assessed by the allocated care team. Appropriate counseling on treatment and symptoms or problems related to diabetes will also be provided. Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the exercise habits will be assessed by the use of questionnaires. In addition the patients' satisfaction from the use of the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service compared with the usual care from the health and social perspective. The effect of the tele-health service in the organization structure of the outpatient hospital department will be evaluated with a qualitative study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Telemonitoring of patients with diabetes type 2 | Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-12-01
- Completion
- 2014-01-01
- First posted
- 2011-12-23
- Last updated
- 2015-02-18
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT01498367. Inclusion in this directory is not an endorsement.