Diabetes Mellitus Type 2, Hypertension
Conditions
Keywords
patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare
Brief 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.
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.
Interventions
DEVICEIntervention group
Sponsors
VTT Technical Research Centre of Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood pressure | 9 months |
| Change in Hba1c(for diabetes patients) | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieving the desired target range | 9 months | Target range for blood pressure is \<= 135/85 mmHg. Target range for glycohemoglobin is \<= 6.5%. |
| Adverse effects | 9 months | hypotension, RR \< 120/80 mmHg |
| Hypoglycemia | 9 months | p-glucose \< 3.5 mmol/l |
| Change in body weight | 9 months | — |
| Change in BMI | 9 months | — |
| Change in medication | 9 months | — |
| Change in FÍNSIK scores | 9 months | — |
Countries
Finland
Outcome results
None listed