Diabetes Mellitus, Type 2RHCluster2GRNCT01498367
Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece
A study testing Telemonitoring of patients with diabetes type 2 in people with Diabetes Mellitus, Type 2, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.
Trial summary
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Telemonitoring of patients with diabetes type 2
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 Diabetes
- HbA1c > 53 mmol/mol (7.0 % according to NGSP)
- Capability to use the devices provided
- Being cognitively able to participate
- Capability of filling in questionnaires in german or greek language
- Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site
Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
Larissa, Thessaly, 41110
About this study
Official title: Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.
Read the detailed description
The present study aims to examine the clinical and financial effects and the patients' perception and satisfaction of home telemedicine support system for diabetes management versus standard (usual) care. In the intervention group the patients will be provided with a blood glucose meter and a mobile phone and their data will be transferred via the mobile to the regional database and will be assessed by the allocated care team. Appropriate counseling on treatment and symptoms or problems related to diabetes will also be provided.
Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the exercise habits will be assessed by the use of questionnaires. In addition the patients' satisfaction from the use of the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service compared with the usual care from the health and social perspective. The effect of the tele-health service in the organization structure of the outpatient hospital department will be evaluated with a qualitative study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Telemonitoring of patients with diabetes type 2
- Keywords
- Diabetes Mellitus, Type 2, Telemedicine
- 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.
Telemonitoring of patients with diabetes type 2Procedure or surgery
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes. |
| Telemonitoring of diabetes 2 patients | Experimental | Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported. Receives: Procedure: Telemonitoring of patients with diabetes type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Measured: 12 months minimum- at the entry point of the intervention and the end.
HbA1c levels
Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)
Measured: 12 months minimum - at the entry point and every 3 months.
Secondary outcomes (5)
Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
Measured: 12 months minimum- at the entry point of the intervention and the end.
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
Measured: 12 months minimum- at the entry point of the intervention and the end.
Nutrition habits assessed by validated questionnaire.
Measured: 12 months minimum- at the entry point of the intervention and the end.
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Measured: at 2nd and at 12th month
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
Measured: 12 months minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Health Authority of Sterea & Thessaly
- Sponsor type
- Other government
- Collaborators
- Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
- Responsible party
- Principal investigator, Georgios Koukoulis, Regional Health Authority of Sterea & Thessaly
- Investigators
- Georgios Koukoulis, MD, PhD, Principal investigator, Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498367
- Sponsor's protocol ID
- FR2015
- Other IDs
- EC Grant Agreement 250487
- Acronym
- RHCluster2GR
- Status last verified
- Feb 2015
- First submitted
- 21 Dec 2011
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.
PubMed 19531058Klonoff DC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical? Diabetes Care. 2003 May;26(5):1626-8. doi: 10.2337/diacare.26.5.1626. No abstract available.
PubMed 12716831Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.
PubMed 17378871
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece
- ClinicalTrials.gov ID
- NCT01498367
- Acronym / sponsor ID
- RHCluster2GR / FR2015
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Regional Health Authority of Sterea & ThessalyOther government
- Collaborators
- Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Dec 2011 (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.
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.
Detailed description
The present study aims to examine the clinical and financial effects and the patients' perception and satisfaction of home telemedicine support system for diabetes management versus standard (usual) care. In the intervention group the patients will be provided with a blood glucose meter and a mobile phone and their data will be transferred via the mobile to the regional database and will be assessed by the allocated care team. Appropriate counseling on treatment and symptoms or problems related to diabetes will also be provided.
Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the exercise habits will be assessed by the use of questionnaires. In addition the patients' satisfaction from the use of the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service compared with the usual care from the health and social perspective. The effect of the tele-health service in the organization structure of the outpatient hospital department will be evaluated with a qualitative study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes. |
| Telemonitoring of diabetes 2 patients | Experimental | Procedure: Telemonitoring of patients with diabetes type 2Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 Diabetes
- HbA1c > 53 mmol/mol (7.0 % according to NGSP)
- Capability to use the devices provided
- Being cognitively able to participate
- Capability of filling in questionnaires in german or greek language
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Telemonitoring of patients with diabetes type 2Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter | Procedure or surgery | Telemonitoring of diabetes 2 patients |
Primary outcome
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time frame: 12 months minimum- at the entry point of the intervention and the end.
HbA1c levels
Time frame: 12 months minimum - at the entry point and every 3 months.
Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)
5 secondary outcomes
Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Nutrition habits assessed by validated questionnaire.
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time frame: at 2nd and at 12th month
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
Time frame: 12 months minimum
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 18 Feb 2015.
- Background: PubMed 19531058Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.
- Background: PubMed 12716831Klonoff DC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical? Diabetes Care. 2003 May;26(5):1626-8. doi: 10.2337/diacare.26.5.1626. No abstract available.
- Background: PubMed 17378871Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.
- "The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community"Link provided by the sponsor.
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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.
Georgios Koukoulis, MD, PhD principal investigator
Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring of patients with diabetes type 2 in people with Diabetes Mellitus, Type 2, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.
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 6 inclusion and 1 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 18 Feb 2015. 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 Greece. 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?
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire (time frame: 12 months minimum- at the entry point of the intervention and the end.). The study lists 2 primary outcomes in all. 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 NCT01498367, which also lists 3 linked publications.
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 18 Feb 2015.