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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Telemonitoring of patients with diabetes type 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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<br>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<br>* Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter<br>|

What is the study measuring?
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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 |  | 12 months minimum- at the entry point of the intervention and the end. | 
| HbA1c levels | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Nutrition habits assessed by validated questionnaire. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Telemedicine