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Completed

NCT Number: NCT00527254

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Primary Care Self Monitoring Blood Glucose Telemedicine

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Province of Malaga Health Department

Málaga, 29001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine System

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.

Primary outcomes

  1. HBA1c Glycosylated hemoglobin

    Time frame: 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

    Time frame: one year for every patient

Sponsors and collaborators

Lead sponsor

Province of Malaga Health Department

Other Gov

Collaborators

  • Roche Diabetes Care

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Sep 10, 2007
Registry last updated
Sep 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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