Can unscheduled inpatient length of stay and hospital costs be reduced using 'flash' glucose monitoring?
ISRCTN | ISRCTN11565460 |
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DOI | https://doi.org/10.1186/ISRCTN11565460 |
IRAS number | 266868 |
Secondary identifying numbers | V2.6 15/04/2021, IRAS 266868 |
- Submission date
- 02/11/2021
- Registration date
- 10/11/2021
- Last edited
- 10/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a serious condition where the blood glucose (sugar) level is too high. Research shows that people with diabetes are significantly more likely to be admitted to hospital than people without diabetes and stay in hospital on average twice as long. This study is seeking to test an intervention to improve glucose monitoring for people with diabetes who have been admitted to hospital.
Who can participate?
Adults (aged 18 years and older) currently admitted to hospital with a diagnosis of diabetes
What does the study involve?
Participants will be randomly allocated into either the intervention or non-intervention group. Participants in the intervention group will wear a Flash Glucose Monitoring device for the duration of their stay in hospital. Flash Glucose Monitoring devices include small sensors worn just under the skin that measure glucose (sugar) levels continuously throughout the day and night and can be checked by simply scanning a monitor over the sensor. Participants' treatment will not be affected or changed but they are asked to check their glucose levels using the monitor to scan the sensor every 2 hours as well as having the usual fingerprick testing carried out in the ward. When they are discharged, they will be given the choice to take home the Flash Glucose Monitoring device for the remaining time left on the sensor (up to a maximum of 2 weeks).
Participants in the non-intervention group will receive routine care for their diabetes while they are in hospital and/or are discharged home as normal when they leave the hospital. All participants will fill out a short questionnaire and the researcher will collect information about their glucose monitoring and diabetes treatment from their notes.
What are the possible benefits and risks of participating?
Participants in the intervention group will have the opportunity to experience the use of technology to monitor their diabetes whilst they are in hospital, and the take-home intervention group could experience the use of this at home following their discharge also. All participants will be given the opportunity to confidentially and anonymously share their experiences and opinions on inpatient diabetes management at their participating hospital. The researchers do not consider there to be any serious risks in taking part. Participants may feel slight discomfort when the sensor is first applied and/or mild skin irritation from the adhesive. Taking part will have no bearing on their health or medical treatment.
Where is the study run from?
Ulster University (UK)
When is the study starting and how long is it expected to run for?
October 2019 to January 2022
Who is funding the study?
Interreg European Regional Development Fund
Who is the main contact?
Kathleen Michelle Friel
friel-k5@ulster.ac.uk
Contact information
Scientific
Ulster University
Institute of Nursing and Health Research
Magee campus
Room G081
Derry
BT48 7JL
United Kingdom
Phone | +44 (0)28 7012 4206 |
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ve.coates@ulster.ac.uk |
Study information
Study design | Randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | 40617_PIS_V1.4_08Oct19.pdf |
Scientific title | Interreg diabetes centre for personalised medicine - unscheduled care in diabetes - study 2: inpatient study |
Study objectives | Can unscheduled inpatient length of stay and hospital costs be reduced using ‘Flash’ glucose monitoring? |
Ethics approval(s) | Approved 14/10/2019, North of Scotland Research Ethics Committee (1) (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; nosres@nhs.net), REC ref: 19/NS/0161 |
Health condition(s) or problem(s) studied | Diabetes mellitus |
Intervention | This is a descriptive developmental mixed-methods study using both qualitative and quantitative approaches with two phases: Phase 2, Part B: pilot study – use of Flash Glucose Monitoring where participants will be randomised into either the active use of Flash Glucose Monitoring or the non-intervention group using individual sequential randomisation. Intervention arm: Participants in the intervention group will be provided with a Freestyle Libre Flash Glucose Monitoring sensor and asked to self-apply the sensor with guidance from the research nurse. Patients will be advised to scan the sensors every 2 hours during waking hours with at least one scan between 10 pm and midnight and 6-8 am. Routine capillary testing will continue to be carried out as per hospital protocol at least four times daily. All measurements will be recorded on the bedside glucose monitoring chart along with a note of any action or intervention based on the glucose result. During the inpatient stay for patients and ward staff to enhance decision making the full dataset of values will be downloaded by the researcher or research nurse daily from the monitor to ‘Libre view’ software and printed out in the ward for patients and staff to view. The researcher will download the full dataset at the end of the 2-week period and note any changes the patient has made to therapy if the sensor is used following discharge from the ward. All participants in the intervention group will be given the option to take the Flash Glucose Monitoring device to use at home for up to 2 weeks, if less than 2 weeks use as an inpatient, following their discharge from hospital. Control arm: Participants in the usual care group will receive standard POC capillary blood glucose testing according to hospital protocols. All participants’ case notes will be reviewed to collect the frequency of tests, the blood glucose readings and whether any intervention was needed. Phase 2, Part C: pilot study – evaluation interviews consisting of both patients who were enrolled into, and healthcare professionals (HCPs) who were involved in the delivery of, the pilot study Part B. Evaluation interviews will be carried out with participants from both study arms following their consent to participate in an interview. |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Flash Glucose Monitoring |
Primary outcome measure | 1. Clinical decision making (changes made to therapy) measured using patient medical records at 4 hourly intervals 2. Patient safety measured using patient medical records at 4 hourly intervals |
Secondary outcome measures | Length of stay (LoS) measured using patient medical records at hospital discharge |
Overall study start date | 14/10/2019 |
Completion date | 31/01/2022 |
Eligibility
Participant type(s) | Mixed |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | A minimum of 60 patients |
Key inclusion criteria | Phase 2, Part B: pilot study – use of Flash Glucose Monitoring: 1. Adults (aged 18 years and older) 2. Diagnosed with diabetes 3. Admitted to hospital wards defined in phase 1 4. Able to read and understand the participant information sheet (PIS) 5. Able to give written informed consent Phase 2, Part C: pilot study - evaluation interviews: 1. Patients or HCPs that have participated in phase 2, part B 2. Able to read and understand the participant information sheet (PIS) 3. Able to give written informed consent |
Key exclusion criteria | Phase 2, Part B: pilot study - use of flash glucose monitoring: 1. Children or young people (aged younger than 18 years) 2. Not diagnosed with diabetes 3. Admitted to hospital wards not defined in phase 1 4. Pregnancy or gestational diabetes 5. Significant intercurrent illness and/or terminal diagnosis 6. Have a condition and/or treatment known to affect variability of blood glucose, such as on kidney dialysis 7. Already using a Flash Glucose Monitoring or continuous monitoring device 8. Unable to read and understand the participant information sheet (PIS) 9. Unable to give written informed consent Phase 2, Part C: pilot study - evaluation interviews: 1. Ongoing significant co-morbid illness 2. Unable to read and understand the participant information sheet |
Date of first enrolment | 19/10/2019 |
Date of final enrolment | 31/01/2022 |
Locations
Countries of recruitment
- Ireland
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Inverness
IV2 3UJ
United Kingdom
Derry
BT47 6SB
United Kingdom
Letterkenny
F92 AE81
Ireland
Sponsor information
University/education
c/o Prof. Donna Heddle
UHI Executive Office
Ness Walk
Inverness
IV3 5SQ
Scotland
United Kingdom
Phone | +44 (0)146327000 |
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Donna.heddle@uhi.ac.uk | |
Website | https://uhi.ac.uk |
https://ror.org/02s08xt61 |
Hospital/treatment centre
3099 Old Perth Rd
Inverness
IV2 3FF
Scotland
United Kingdom
Phone | +44 (0)1463 704876 |
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sandra.macrury@nhs.scot | |
Website | https://www.nhshighland.scot.nhs.uk/ |
https://ror.org/010ypq317 |
Funders
Funder type
Government
Government organisation / National government
No information available
Results and Publications
Intention to publish date | 31/05/2022 |
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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 | Publications are planned for in high-impact peer-reviewed journals and through presentations at international and national healthcare and diabetes-related conferences. |
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 | Evaluative interview version 1.4 |
08/10/2019 | 03/11/2021 | No | Yes |
Participant information sheet | Intervention study version 1.5 |
08/10/2019 | 03/11/2021 | No | Yes |
Protocol file | version 2.6 | 15/04/2021 | 03/11/2021 | No | No |
Results article | 28/11/2021 | 10/05/2022 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |
Additional files
- 40617_PIS_V1.5_08Oct19.pdf
- Intervention study
- 40617_PIS_V1.4_08Oct19.pdf
- Evaluative interview
- 40617_PROTOCOL_V.2.6_15Apr21.pdf
Editorial Notes
10/05/2022: Publication reference added.
14/01/2022: Sponsor contact details updated.
12/01/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2021 to 31/01/2022.
2. The intention to publish date was changed from 01/05/2022 to 31/05/2022.
10/01/2022: Sponsor contact details updated.
03/11/2021: Trial's existence confirmed by North of Scotland Research Ethics Committee (1).