Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the Public National Primary Care System.

Detailed Description
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The UKPDS study in type 2 diabetes and the DCCT in type 1, showed that intensive blood glucose control and the following HBA1c decrease were associated with a decrease of diabetic complications. Introducing telecontrol elements in the real time follow up of the patients, should help to know continuously patient blood glucose profile and add if necessary immediately therapeutical variations, to maintain HbA1c levels as low as possible. The study compares type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit with the extra support of a real time teleassistance system with type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit.

Conditions
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Type 2 Diabetes, Telemedicine, Self Monitoring Blood Glucose, Primary Care

Intervention / Treatment
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* Device: Telemedicine system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 Diabetes on SMBG al least 6 months before age superior of 30 years controlled in province of Málaga Primary Care Units Exclusion Criteria: having diabetic complications or other diseases that could make difficult to use the telemedicine system patients who need a carer not passing the initial training (low cultural level) living in an area without mobile phone coverage

Ages Eligible for Study
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Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Active Comparator: Telemedicine group<br> | Device: Telemedicine system<br>* Possibility of sending the SMBG values of the patients to a web page via phone mobile sms messages. The HCP had a password access to this web page to check the blood glucose values of the patients and if necessary send to them sms messages with recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1c Glycosylated hemoglobin |  | one year for every patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence |  | one year for every patient |