Diabetes Mellitus, Type 2 Clinical Trial
— RHCluster2GROfficial title:
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Greece | Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa | Larisa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
Regional Health Authority of Sterea & Thessaly | Alexander Technological Educational Institute, Thessaloniki, Greece, Cities Net SA, e-Trikala S.A., 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 |
Greece,
Jaana M, Paré G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. Review. — View Citation
Klonoff DC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical? Diabetes Care. 2003 May;26(5):1626-8. Review. — View Citation
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Primary | 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. | No |
Secondary | 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. | No | |
Secondary | Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ) | 12 months minimum- at the entry point of the intervention and the end. | No | |
Secondary | Nutrition habits assessed by validated questionnaire. | 12 months minimum- at the entry point of the intervention and the end. | No | |
Secondary | Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | at 2nd and at 12th month | No | |
Secondary | Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) | 12 months minimum | No |
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