Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Telemedicine
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.
Interventions
PROCEDURETelemonitoring of patients with diabetes type 2
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
Sponsors
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
e-Trikala S.A.
Cities Net SA
Institute of Biomedical Research & Technology, Larissa, Greece
Institute of Communications and Computer Systems, Athens, Greece
Alexander Technological Educational Institute, Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Regional Health Authority of Sterea & Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
| Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) | 12 months minimum |
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | at 2nd and at 12th month |
| Physical activity measured by the International Physical Activity Questionnaire (IPAQ) | 12 months minimum- at the entry point of the intervention and the end. |
Countries
Greece
Outcome results
None listed