Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient - Full Text View

Sponsors and Collaborators:	Province of Malaga Health Department Hoffmann-La Roche
Information provided by:	Province of Malaga Health Department
ClinicalTrials.gov Identifier:	NCT00527254

Purpose

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.

Condition	Intervention
Type 2 Diabetes Telemedicine Self Monitoring Blood Glucose Primary Care	Device: Telemedicine system

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Province of Malaga Health Department:

Primary Outcome Measures:

HBA1c Glycosylated hemoglobin [ Time Frame: one year for every patient ]

Secondary Outcome Measures:

Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence [ Time Frame: one year for every patient ]

Enrollment:	328
Study Start Date:	October 2003
Study Completion Date:	June 2005

Arms	Assigned Interventions
Control group: No Intervention
Telemedicine group: Active Comparator	Device: Telemedicine system 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.

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527254

Locations

Spain
Province of Malaga Health Department
Málaga, Spain, 29001

Sponsors and Collaborators

Province of Malaga Health Department

Hoffmann-La Roche

Investigators

Principal Investigator:

Maria Isabel Rodríguez Idígoras, Doctor

Málaga Health Department (Junta de Andalucia)

More Information

No publications provided

Study ID Numbers:	TeleDiabecom 200501
Study First Received:	September 7, 2007
Last Updated:	September 7, 2007
ClinicalTrials.gov Identifier:	NCT00527254 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009