Blood pressure and blood glucose telemonitoring in seniors

ISRCTN	ISRCTN31471852
DOI	https://doi.org/10.1186/ISRCTN31471852
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ScubyTel-825432
Sponsor	Community Health Centre Ljubljana
Funder	H2020 Health - Health programme (H2020-SC1) contract number 825432 - SCUBY

Submission date: 20/09/2021
Registration date: 05/10/2021
Last edited: 24/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Arterial hypertension (high blood pressure) and diabetes are a significant burden on the general health of the population. This study will examine whether the addition of smart technology in the form of telemonitoring (i.e. disease control at a distance) improves the management of these chronic conditions. The main aim is to find out whether blood pressure (BP) and blood glucose (BG) telemonitoring is better than standard care in the BP and BG reduction. The secondary aim is to evaluate whether BP and BG telemonitoring is a feasible method for patients and healthcare workers.

Who can participate?
Patients aged 65 years or over with arterial hypertension and type 2 diabetes

What does the study involve?
Participants will be randomly allocated to the telemedicine group or the control group. Participants in the telemedicine group will receive a telemedicine package which will include a smartphone, blood pressure and blood glucose monitor. They will take their blood pressure two times weekly and blood glucose once monthly. Data will be transmitted via smartphone to the telemonitoring platform. The telemedicine centre coordinator (physician) will examine transmitted values and indicate appropriate interventions (e.g., change in treatment, referral to GP, phone consultation). The control group will receive standard care only. The researchers will also sample blood for laboratory tests in both groups at the start of the study and after 12 months.

What are the possible benefits and risks of participating?
Patients in the telemedicine group will receive a telemedicine package. Measurement of blood pressure is a non-invasive and safe procedure. Blood glucose measurement may cause minimal pain in the fingers, dizziness, or inflammation at the measurement site. No significant side effects are expected.

Where is the study run from?
The Primary Healthcare Centre Ljubljana (Slovenia)

When is the study starting and how long is it expected to run for?
January 2021 to September 2023

Who is funding the study?
EU H2020 - Health programme (H2020-SC1)

Who is the main contact?
Prof. Antonija Poplas Susič
antonija.poplas-susic@zd-lj.si

Contact information

Dr Matic Mihevc
Scientific

Metelkova ulica 9
Ljubljana
1000
Slovenia

ORCID ID	0000-0003-4041-8682
Phone	+386 (0)40 520 247
Email	mihevc.matic@zd-tr.si

Prof Antonija Poplas Susič
Scientific

Metelkova ulica 9
Ljubljana
1000
Slovenia

ORCID ID	0000-0002-4328-3333
Phone	+386 (0)1 300 39 41
Email	antonija.poplas-susic@zd-lj.si

Study information

Primary study design	Interventional
Study design	Multicentre randomized controlled study
Secondary study design	Randomised controlled trial
Participant information sheet	40451_PIS.pdf
Scientific title	Telemonitoring of patients with comorbid hypertension and type 2 diabetes mellitus: a multicentre randomised controlled pilot study
Study acronym	ScubyTel
Study objectives	The goals of the study are: 1. To evaluate the effect of blood pressure (BP) and blood glucose (BG) telemonitoring (TM) on BP and BG reduction in a group of patients with comorbid arterial hypertension (AH) and type 2 diabetes mellitus (T2DM) 2. To evaluate BP and BG TM's effect on mental health (depressive and anxiety symptoms) and other behavioural risk factors (daily activity, nutrition, alcohol consumption, smoking) 3. To evaluate the effect of BP and BG TM on quality of life 4. To evaluate the acceptability of BP and BG TM for patients and healthcare workers 5. To evaluate costs associated with the intervention and perform a cost-effectiveness analysis
Ethics approval(s)	Approved 24/05/2019, Slovenian National Medical Ethics Committee (Komisija Republike Slovenije za medicinsko etiko, Štefanova ulica 5, SI-1000 Ljubljana, Slovenia; +386 (0)1 478 69 06; kme.mz@gov.si), ref: 0120-219/2019/4
Health condition(s) or problem(s) studied	Prevention of cardiovascular disease in patients with diabetes and arterial hypertension
Intervention	The SCUBY telemedicine pilot study is a randomised controlled study comparing telemonitoring of blood pressure and blood glucose (intervention group) with a standard care (control group). This multicentre pilot study will run in three primary healthcare centres in Slovenia and will last for 12 months. It will include patients with hypertension and diabetes mellitus type 2 over 65 years of age who will be randomised in a 1:1 ratio to the experimental or control group. After consented to participate, patients will be randomised to either the intervention or control group. We will use a simple 1:1 randomisation. The first patient on the list will be randomised to the telemedicine group (intervention group). The second patient will be randomised to the standard care group (control group). If candidates drop out within the first week of the study, new patients will be sought. These will be randomised according to the previous randomisation list of patients. If the last patient on the list was randomised to the telemedicine group, the next patient will be randomised to the control group and vice versa. Patients in the intervention group will receive a telemedicine package (blood glucose monitor, blood pressure monitor, smartphone) and take blood pressure twice weekly and blood glucose once monthly according to the protocol. Data will be transmitted via smartphone to the telemonitoring platform, where the telemedicine centre coordinator (physician) will examine transmitted values and indicate appropriate interventions (e.g., change in protocol regimen, referral to GP, phone consultation). The control group will receive standard care only.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Not provided at time of registration
Primary outcome measure(s)	1. Systolic blood pressure measured with standardised BP monitors at baseline, 6 months, and 12 months 2. Glycated haemoglobin assessed with laboratory testing at baseline and 12 months.
Key secondary outcome measure(s)	1. Diastolic blood pressure measured with standardised BP monitors at baseline, 6 months, and 12 months 2. Lipid profile assessed with laboratory testing at baseline and 12 months 3. Glomerular filtration rate assessed with laboratory testing at baseline and 12 months 4. Body mass index assessed with standardised scales at baseline and 12 months 5. Appraisal of diabetes measured with the Appraisal of Diabetes scale at baseline and 12 months 6. Depressive symptoms measured with the Patient Health Questionnaire-9 at baseline and 12 months 7. Anxiety symptoms measured with the General Anxiety Disorder-7 questionnaire at baseline and 12 months
Completion date	01/09/2023

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	65 Years
Sex	All
Target sample size at registration	120
Total final enrolment	128
Key inclusion criteria	1. ≥65 years of age 2. AH and T2DM 3. Diagnosis of AH and T2DM for at least 1 year 4. Capability of smartphone use
Key exclusion criteria	1. <65 years of age 2. T2DM on insulin treatment 3. Type 1 diabetes or gestational diabetes 4. Cognitive impairment
Date of first enrolment	15/03/2021
Date of final enrolment	01/06/2022

Locations

Countries of recruitment

Slovenia

Study participating centres

Zdravstveni dom Ljubljana

Metelkova ulica 9
Ljubljana
1000
Slovenia

Zdravstveni dom Trebnje

Goliev trg 9
Trebnje
8210
Slovenia

Zdravstveni dom Slovenj Gradec

Partizanska pot 16
Slovenj Gradec
2380
Slovenia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from the principal investigator Prof. Antonija Poplas Susič (antonija.poplas-susic@zd-lj.si) (e.g., for meta-analyses).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/05/2024	24/10/2024	Yes	No
Results article		01/03/2024	24/10/2024	Yes	No
Protocol article		28/09/2022	07/03/2023	Yes	No
Dataset			24/10/2024	No	No
Participant information sheet			22/09/2021	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	see section 2.13	28/09/2022	07/03/2023	No	No

Additional files

40451_PIS.pdf: Participant information sheet

Editorial Notes

24/10/2024: The following changes were made to the trial record:
1. The total final enrolment was changed from 120 to 128.
2. Publication reference added.
3. Link to dataset added.
16/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2023 to 01/09/2023.
2. The total final enrolment was added.
07/03/2023: Publication reference added.
22/09/2021: Trial's existence confirmed by the Slovenian National Medical Ethics Committee.