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

September 7, 2007 updated by: Province of Malaga Health Department
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29001
        • Province of Malaga Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBA1c Glycosylated hemoglobin
Time Frame: one year for every patient
one year for every patient

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year for every patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Province of Malaga Health Department

Collaborators

Roche Diagnostics Spain (Diabetes Care)

Investigators

  • Principal Investigator: Maria Isabel Rodríguez Idígoras, Doctor, Málaga Health Department (Junta de Andalucia)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (ESTIMATE)

September 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 7, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TeleDiabecom 200501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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