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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: Control group
Active Comparator: Telemedicine group 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 by Province of Malaga Health Department

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013