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

Primary Purpose

Type 2 Diabetes, Telemedicine, Self Monitoring Blood Glucose

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine system
Sponsored by
Province of Malaga Health Department
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Province of Malaga Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Telemedicine group

Arm Description

Outcomes

Primary Outcome Measures

HBA1c Glycosylated hemoglobin

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2007
Last Updated
September 7, 2007
Sponsor
Province of Malaga Health Department
Collaborators
Roche Diagnostics Spain (Diabetes Care)
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1. Study Identification

Unique Protocol Identification Number
NCT00527254
Brief Title
Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Province of Malaga Health Department
Collaborators
Roche Diagnostics Spain (Diabetes Care)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Telemedicine, Self Monitoring Blood Glucose, Primary Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
Telemedicine group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Telemedicine system
Intervention Description
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 Outcome Measure Information:
Title
HBA1c Glycosylated hemoglobin
Time Frame
one year for every patient
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Isabel Rodríguez Idígoras, Doctor
Organizational Affiliation
Málaga Health Department (Junta de Andalucia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Province of Malaga Health Department
City
Málaga
ZIP/Postal Code
29001
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19580356
Citation
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.
Results Reference
derived

Learn more about this trial

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

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