Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Procedure: Telemonitoring of patients with diabetes type 2

• Registration Number: NCT01498367
• Lead Sponsor: Regional Health Authority of Sterea & Thessaly

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Diagnosis of type 2 Diabetes
• HbA1c > 53 mmol/mol (7.0 % according to NGSP)
• Capability to use the devices provided
• Being cognitively able to participate
• Capability of filling in questionnaires in german or greek language
• Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring of diabetes 2 patients	Telemonitoring of patients with diabetes type 2	Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported.

Primary Outcome Measures

Name	Time	Method
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire	12 months minimum- at the entry point of the intervention and the end.
HbA1c levels	12 months minimum - at the entry point and every 3 months.	Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)

Secondary Outcome Measures

Name	Time	Method
Nutrition habits assessed by validated questionnaire.	12 months minimum- at the entry point of the intervention and the end.
Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"	12 months minimum- at the entry point of the intervention and the end.
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)	12 months minimum- at the entry point of the intervention and the end.
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire	at 2nd and at 12th month
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)	12 months minimum

Trial Locations

Locations (1)

Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa; 🇬🇷 Larisa, Thessaly, Greece