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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Telemedicine; Self Monitoring Blood Glucose; Primary Care
• Interventions: Device: Telemedicine system

• Registration Number: NCT00527254
• Lead Sponsor: Province of Malaga Health Department

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-06
• Status Verified: 2007-09
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Last Update Submitted: 2007-09-07
• Study First Posted: 2007-09-10
• Last Update Posted: 2007-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine group	Telemedicine system	-

Primary Outcome Measures

Name	Time	Method
HBA1c Glycosylated hemoglobin	one year for every patient

Secondary Outcome Measures

Name	Time	Method
Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence	one year for every patient

Trial Locations

Locations (1)

Province of Malaga Health Department; 🇪🇸 Málaga, Spain