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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Province of Malaga Health Department
ClinicalTrials.gov Identifier:
NCT00527254
First received: September 7, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 7, 2007
September 7, 2007
October 2003
Not Provided
HBA1c Glycosylated hemoglobin [ Time Frame: one year for every patient ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient
Not Provided

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Type 2 Diabetes
  • Telemedicine
  • Self Monitoring Blood Glucose
  • Primary Care
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.
  • No Intervention: Control group
  • Active Comparator: Telemedicine group
    Intervention: Device: Telemedicine system
Rodríguez-Idígoras MI, Sepúlveda-Muñoz J, Sánchez-Garrido-Escudero R, Martínez-González JL, Escolar-Castelló JL, Paniagua-Gómez IM, Bernal-López R, Fuentes-Simón MV, Garófano-Serrano D. Telemedicine influence on the follow-up of type 2 diabetes patients. Diabetes Technol Ther. 2009 Jul;11(7):431-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
June 2005
Not Provided

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00527254
TeleDiabecom 200501
No
Not Provided
Province of Malaga Health Department
Hoffmann-La Roche
Principal Investigator: Maria Isabel Rodríguez Idígoras, Doctor Málaga Health Department (Junta de Andalucia)
Province of Malaga Health Department
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP