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Completed

NCT Number: NCT01498367

Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring of patients with diabetes type 2

Procedure

Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. Nutrition habits assessed by validated questionnaire.

    Time frame: 12 months minimum- at the entry point of the intervention and the end.

  4. Patients' Acceptance-Satisfaction measured by the WSD Questionnaire

    Time frame: at 2nd and at 12th month

  5. Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

    Time frame: 12 months minimum

Sponsors and collaborators

Lead sponsor

Regional Health Authority of Sterea & Thessaly

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: RHCluster2GR

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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