Diabetes Mellitus Type 2NCT01547156
Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
A study testing Intervention group in people with Diabetes Mellitus Type 2 and Hypertension, run by VTT Technical Research Centre of Finland at 1 site in Finland.
Trial summary
Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Hypertension
- What is being tested?
- Intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFinland
- Study dates
- May 2011to Jun 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
- For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
- Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
- use of diabetes medication
Who cannot join
- Patients who decline to participate
- Patients specifically excluded by the health centre physician
- Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
- Pregnancy
- Patients with a life expectance of less than one year
- Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.
- Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Sipoo a Randomized Controlled Trial
Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.
Read the detailed description
Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Being tested
- Intervention group
- Keywords
- patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group received usual care |
| Telemonitoring group | Experimental | Intervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices. Receives: Device: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: 9 months
Change in Hba1c(for diabetes patients)
Measured: 9 months
Secondary outcomes (7)
Achieving the desired target range
Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.
Measured: 9 months
Adverse effects
hypotension, RR < 120/80 mmHg
Measured: 9 months
Hypoglycemia
p-glucose < 3.5 mmol/l
Measured: 9 months
Change in body weight
Measured: 9 months
Change in BMI
Measured: 9 months
Change in medication
Measured: 9 months
Change in FÍNSIK scores
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTT Technical Research Centre of Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547156
- Sponsor's protocol ID
- MobileSipoo
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2012
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Sipoo a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01547156
- Acronym / sponsor ID
- MobileSipoo
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Keywords
- patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VTT Technical Research Centre of FinlandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Mar 2012 (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.
Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.
Detailed description
Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group received usual care |
| Telemonitoring group | Experimental | Device: Intervention groupIntervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
- For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
- Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
- use of diabetes medication
Key exclusion criteria (7 listed)
- Patients who decline to participate
- Patients specifically excluded by the health centre physician
- Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
- Pregnancy
- Patients with a life expectance of less than one year
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 |
|---|---|---|
| Intervention group | Device | Telemonitoring group |
Primary outcome
Change in blood pressure
Time frame: 9 months
Change in Hba1c(for diabetes patients)
Time frame: 9 months
7 secondary outcomes
Achieving the desired target range
Time frame: 9 months
Adverse effects
Time frame: 9 months
Hypoglycemia
Time frame: 9 months
Change in body weight
Time frame: 9 months
Change in BMI
Time frame: 9 months
Change in medication
Time frame: 9 months
Change in FÍNSIK scores
Time frame: 9 months
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 Mar 2016.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Diabetes Mellitus Type 2 and Hypertension, run by VTT Technical Research Centre of Finland at 1 site in Finland.
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 7 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 Mar 2016. 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 Finland. 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?
Change in blood pressure (time frame: 9 months). 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?
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 Mar 2016.