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CompletedNCT01547156Updated Mar 10, 2016

Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

An interventional study of Intervention group in Diabetes Mellitus Type 2 and Hypertension, sponsored by VTT Technical Research Centre of Finland. Completed at 1 site in Finland. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-10.

Sponsored by VTT Technical Research Centre of Finland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus Type 2
  • Hypertension

Keywords

  • patient decision support
  • telemonitoring
  • self-management
  • remote patient monitoring
  • active assistance technology
  • selfcare
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 56 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

VTT Technical Research Centre of Finland is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • No intervention
    Control group

    Control group received usual care

  • Experimental
    Telemonitoring group

    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.

    Device: Intervention group

Interventions

  • DeviceIntervention group
06

What researchers measure

Primary outcomes

  1. Change in blood pressure

    Time frame: 9 months

  2. Change in Hba1c(for diabetes patients)

    Time frame: 9 months

Secondary outcomes

  1. Achieving the desired target range

    Target range for blood pressure is \<= 135/85 mmHg. Target range for glycohemoglobin is \<= 6.5%.

    Time frame: 9 months

  2. Adverse effects

    hypotension, RR \< 120/80 mmHg

    Time frame: 9 months

  3. Hypoglycemia

    p-glucose \< 3.5 mmol/l

    Time frame: 9 months

  4. Change in body weight

    Time frame: 9 months

  5. Change in BMI

    Time frame: 9 months

  6. Change in medication

    Time frame: 9 months

  7. Change in FÍNSIK scores

    Time frame: 9 months

07

Study locations

1 site
  • Sipoo Health Care Centre
    Sipoo, Finland
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01547156
Lead sponsor
VTT Technical Research Centre of Finland
Responsible party
Sponsor
First posted
Mar 7, 2012
Start date
May 2011
Primary completion
Mar 2012
Completion
Jun 2012
Last update
Mar 10, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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