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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00527254
Other study ID # TeleDiabecom 200501
Secondary ID
Status Completed
Phase N/A
First received September 7, 2007
Last updated September 7, 2007
Start date October 2003
Est. completion date June 2005

Study information

Verified date September 2007
Source Province of Malaga Health Department
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 328
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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 Design

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


Intervention

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.

Locations

Country Name City State
Spain Province of Malaga Health Department Málaga

Sponsors (2)

Lead Sponsor Collaborator
Province of Malaga Health Department Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBA1c Glycosylated hemoglobin one year for every patient
Secondary Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence one year for every patient
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