Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece (RHCluster2GR)

February 16, 2015 updated by: Georgios Koukoulis, Regional Health Authority of Sterea & Thessaly

Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larisa, Thessaly, Greece, 41110
        • Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual care
Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes.
EXPERIMENTAL: Telemonitoring of diabetes 2 patients
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.
Procedure: Telemonitoring of patients with diabetes type 2
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time Frame: 12 months minimum- at the entry point of the intervention and the end.
12 months minimum- at the entry point of the intervention and the end.
HbA1c levels
Time Frame: 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)
12 months minimum - at the entry point and every 3 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Health Authority of Sterea & Thessaly

Collaborators

University of Thessaly
Alexander Technological Educational Institute, Thessaloniki, Greece
Institute of Communications and Computer Systems, Athens, Greece
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
Institute of Biomedical Research & Technology, Larissa, Greece
University of Macedonia, Thessaloniki, Greece
e-Trikala S.A.
Cities Net SA

Investigators

  • Principal Investigator: Georgios Koukoulis, MD, PhD, Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (ESTIMATE)

December 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR2015
  • EC Grant Agreement 250487 (Other Grant/Funding Number: European Commission CIP/PSP-ICT Grant Agreement 250487)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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