Patient real-world handling of protein medications

ISRCTN	ISRCTN17179811
DOI	https://doi.org/10.1186/ISRCTN17179811
IRAS number	331245
Secondary identifying numbers	2-062-23, IRAS 331245

Submission date: 22/09/2023
Registration date: 26/09/2023
Last edited: 23/06/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of this study is to understand better what happens to people’s medicines once patients have collected them from a pharmacy or they have been delivered to the patient at home. The researchers are particularly interested in what happens to a group of medicines called protein medicines which are used to treat a wide number of health conditions (for example insulin in diabetes, some treatments for inflammatory conditions, skin conditions and other health problems). They are interested in protein medicines in particular because these medicines may be more prone to being affected by how and where they are stored and how they are transported. Using a credit-card-sized smart label containing sensors, which will be attached to medication packaging, this study will investigate how much light and moisture the medicine is exposed to as well as what temperature, movements and vibrations it experiences during normal storage and handling by patients.

Who can participate?
Adults aged 18 years and over who are currently prescribed protein medications for administration outside a healthcare setting

What does the study involve?
Participants will be given an activated smart label to attach to their protein drug packaging. This will record movement, humidity, temperature and light until the patient uses the drug. The label will then be returned to the study team where the data will be extracted and analysed.

What are the possible benefits and risks of participating?
There are no risks to taking part. Benefits will be for future users of the medication in the form of better education on protein drug handling for patients and healthcare providers.

Where is the study run from?
MEMO Research, University of Dundee based in Ninewells Hospital and Medical School, Dundee (UK)

When is the study starting and how long is it expected to run for?
February 2023 to June 2025

Who is funding the study?
Innovative Medicines Initiative (Belgium)

Who is the main contact?
Prof. Isla Mackenzie, memo-info@dundee.ac.uk

Contact information

Prof Isla Mackenzie
Principal Investigator

MEMO Research
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

ORCID ID	0000-0002-3680-7127
Phone	+44 (0)1382 383119
Email	memo-info@dundee.ac.uk

Study information

Study design	Single-centre questionnaire and observational study
Primary study design	Observational
Secondary study design	Questionnaire
Study setting(s)	Home, Hospital
Study type	Other
Participant information sheet	44311_PIS_V1_25Jul23.pdf
Scientific title	Patient real-world handling of protein medications – a smart label study
Study objectives	The aim is to gain information about how protein medications are handled by patients during collection, storage and use at home. This will improve our understanding of environmental stressors such as temperature, shock, humidity and light that protein medications may be exposed to during normal transport, storage and use by patients. Data will be collected by attaching smart labels with sensors that monitor light, humidity, temperature and accelerometry to patients’ medication packets. Patients will also be asked to complete a short diary to record any events that may occur such as inadvertent exposure to high or low temperatures, or dropping of medication.
Ethics approval(s)	Approved 19/09/2023, East Midlands - Nottingham 2 Research Ethics Committee (Health Research Authority, Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8169, +44 (0)207 104 8278, +44 (0)208 104 8051; nottingham2.rec@hra.nhs.uk), ref: 23/EM/0207
Health condition(s) or problem(s) studied	Cardiovascular disease, diabetes, rheumatology and gastroenterology
Intervention	The study will involve collecting data on environmental stressors using a participant diary and smart labels attached to medication packaging over a period of around 1 month.
Intervention type	Other
Primary outcome measure	Medication movement, humidity, temperature and light exposure measured using smart label sensors following medication collection for a period of up to 1 month
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	20/02/2023
Completion date	30/06/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	Both
Target number of participants	20
Total final enrolment	12
Key inclusion criteria	1. Adults >=18 years old currently prescribed protein medications for administration outwith a healthcare setting 2. Able to give informed consent
Key exclusion criteria	1. Patients requiring administration of their medication in a hospital setting 2. Patients prescribed protein medications that are administered at intervals of greater than fortnightly
Date of first enrolment	02/10/2023
Date of final enrolment	30/04/2025

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Ninewells Hospital

Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee
University/education

TASC, Ninewells Hospital and Medical School
Dundee
DD1 9SY
Scotland
United Kingdom

Phone	+44 (0)1382 383900
Email	tascgovernance@dundee.ac.uk
Website	http://www.dundee.ac.uk/
"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Research organisation

Innovative Medicines Initiative
Private sector organisation / Other non-profit organizations

Alternative name(s): The Innovative Medicines Initiative, Europe's Innovative Medicines Initiative, EU Innovative Medicines Initiative, IMI
Location: Belgium

Results and Publications

Intention to publish date	31/07/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in peer-reviewed journal and presentation at scientific conference
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1	25/07/2023	25/09/2023	No	Yes
Participant information sheet	version 2	18/09/2023	23/06/2025	No	Yes

Additional files

44311_PIS_V1_25Jul23.pdf
ISRCTN17179811_PIS_V2_18Sept2023.pdf

Editorial Notes

23/06/2026: Participant information sheet version 2.0 uploaded.
13/05/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 31/05/2025 to 30/04/2025.
10/09/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2024 to 31/05/2025.
2. The overall end date was changed from 31/10/2024 to 30/06/2025.
3. The intention to publish date was changed from 31/12/2024 to 31/07/2025.
4. The plain English summary was updated to reflect these changes.
08/03/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/03/2024 to 30/09/2024.
2. The overall study end date was changed from 31/07/2024 to 31/10/2024.
18/12/2023: The recruitment end date was changed from 31/12/2023 to 31/03/2024.
25/09/2023: Study's existence confirmed by the East Midlands - Nottingham 2 Research Ethics Committee.