Type 2 DiabetesNCT00527254
Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient
A study testing Telemedicine system in people with Type 2 Diabetes and Telemedicine, run by Province of Malaga Health Department at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes, Telemedicine, Self Monitoring Blood Glucose
- What is being tested?
- Telemedicine system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2003to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Telemedicine system
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Telemedicine group | Active comparator | Not described Receives: Device: Telemedicine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBA1c Glycosylated hemoglobin
Measured: 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
Measured: one year for every patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Province of Malaga Health Department
- Sponsor type
- Other government
- Collaborators
- Roche Diabetes Care
- Investigators
- Maria Isabel Rodríguez Idígoras, Doctor, Principal investigator, Málaga Health Department (Junta de Andalucia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527254
- Sponsor's protocol ID
- TeleDiabecom 200501
- Status last verified
- Sep 2007
- First submitted
- 7 Sep 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19580356
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient
- ClinicalTrials.gov ID
- NCT00527254
- Acronym / sponsor ID
- TeleDiabecom 200501
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Province of Malaga Health DepartmentOther government
- Collaborators
- Roche Diabetes Care
- Study start
- Oct 2003
- Study completion
- Jun 2005 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Telemedicine group | Active comparator | Device: Telemedicine system |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine systemPossibility 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. | Device | Telemedicine group |
Primary outcome
HBA1c Glycosylated hemoglobin
Time frame: one year for every patient
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
- Derived from this study: PubMed 19580356Rodriguez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Isabel Rodríguez Idígoras, Doctor principal investigator
Málaga Health Department (Junta de Andalucia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine system in people with Type 2 Diabetes and Telemedicine, run by Province of Malaga Health Department at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBA1c Glycosylated hemoglobin (time frame: one year for every patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2007.