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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527254
• Other study ID #: TeleDiabecom 200501
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Primary Care
• Self Monitoring Blood Glucose
• Telemedicine
• Type 2 Diabetes

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