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

NCT ID: NCT00527254

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Telemedicine Self Monitoring Blood Glucose Primary Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Telemedicine group

Group Type ACTIVE_COMPARATOR

Telemedicine system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diabetes Care

INDUSTRY

Sponsor Role collaborator

Province of Malaga Health Department

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Maria Isabel Rodríguez Idígoras, Doctor

Role: PRINCIPAL_INVESTIGATOR

Málaga Health Department (Junta de Andalucia)

Locations

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Province of Malaga Health Department

Málaga, Málaga, Spain

Site Status

Countries

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Spain

References

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Rodriguez-Idigoras MI, Sepulveda-Munoz J, Sanchez-Garrido-Escudero R, Martinez-Gonzalez JL, Escolar-Castello JL, Paniagua-Gomez IM, Bernal-Lopez R, Fuentes-Simon MV, Garofano-Serrano D. Telemedicine influence on the follow-up of type 2 diabetes patients. Diabetes Technol Ther. 2009 Jul;11(7):431-7. doi: 10.1089/dia.2008.0114.

Reference Type DERIVED
PMID: 19580356 (View on PubMed)

Other Identifiers

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TeleDiabecom 200501

Identifier Type: -

Identifier Source: org_study_id