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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00527254
Enrollment
328
Registered
2007-09-10
Start date
2003-10-31
Completion date
2005-06-30
Last updated
2007-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed 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.

Interventions

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.

Sponsors

Roche Diabetes Care
CollaboratorINDUSTRY
Province of Malaga Health Department
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HBA1c Glycosylated hemoglobinone year for every patient

Secondary

MeasureTime frame
Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherenceone year for every patient

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026