Can unscheduled inpatient length of stay and hospital costs be reduced using 'flash' glucose monitoring?

ISRCTN ISRCTN11565460
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Vivien Coates
Scientific

Ulster University
Institute of Nursing and Health Research
Magee campus
Room G081
Derry
BT48 7JL
United Kingdom

Phone +44 (0)28 7012 4206
Email ve.coates@ulster.ac.uk

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet 40617_PIS_V1.4_08Oct19.pdf
Scientific titleInterreg diabetes centre for personalised medicine - unscheduled care in diabetes - study 2: inpatient study
Study objectivesCan 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) studiedDiabetes mellitus
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Flash Glucose Monitoring
Primary outcome measure1. 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 measuresLength of stay (LoS) measured using patient medical records at hospital discharge
Overall study start date14/10/2019
Completion date31/01/2022

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA minimum of 60 patients
Key inclusion criteriaPhase 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 criteriaPhase 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 enrolment19/10/2019
Date of final enrolment31/01/2022

Locations

Countries of recruitment

  • Ireland
  • Northern Ireland
  • Scotland
  • United Kingdom

Study participating centres

Raigmore Hospital
Old Perth Rd
Inverness
IV2 3UJ
United Kingdom
Altnagelvin Area Hospital
Glenshane Road
Derry
BT47 6SB
United Kingdom
Letterkenny University Hospital
Kilmacrennan Road
Letterkenny
F92 AE81
Ireland

Sponsor information

University of the Highlands and Islands
University/education

c/o Prof. Donna Heddle
UHI Executive Office
Ness Walk
Inverness
IV3 5SQ
Scotland
United Kingdom

Phone +44 (0)146327000
Email Donna.heddle@uhi.ac.uk
Website https://uhi.ac.uk
ROR logo "ROR" https://ror.org/02s08xt61
NHS Highland
Hospital/treatment centre

3099 Old Perth Rd
Inverness
IV2 3FF
Scotland
United Kingdom

Phone +44 (0)1463 704876
Email sandra.macrury@nhs.scot
Website https://www.nhshighland.scot.nhs.uk/
ROR logo "ROR" https://ror.org/010ypq317

Funders

Funder type

Government

Interreg
Government organisation / National government

No information available

Results and Publications

Intention to publish date31/05/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublications are planned for in high-impact peer-reviewed journals and through presentations at international and national healthcare and diabetes-related conferences.
IPD sharing planThe 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).