NCT00527254

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2007

First QC Date

September 7, 2007

Last Update Submit

September 7, 2007

Conditions

Type 2 DiabetesTelemedicineSelf Monitoring Blood GlucosePrimary Care

Outcome Measures

Primary Outcomes (1)

  • HBA1c Glycosylated hemoglobin

    one year for every patient

Secondary Outcomes (1)

  • Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence

    one year for every patient

Study Arms (2)

Control group

NO INTERVENTION

Telemedicine group

ACTIVE COMPARATOR
Device: Telemedicine system

Interventions

Telemedicine systemDEVICE

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.

Telemedicine group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Province of Malaga Health Department

Málaga, Málaga, 29001, Spain

Location

Related Publications (1)

  • 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.

    PMID: 19580356DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Maria Isabel Rodríguez Idígoras, Doctor

    Málaga Health Department (Junta de Andalucia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 10, 2007

Study Start

October 1, 2003

Study Completion

June 1, 2005

Last Updated

September 10, 2007

Record last verified: 2007-09

Locations

ES(1)