Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000328774
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
22/02/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Flash glucose monitoring and telehealth Rapid Access Diabetes Service (RADS) compared to finger prick blood glucose checking and face to face appointments for adults with diabetes who are undergoing discharge from an acute care hospital.
Scientific title
Flash-RADS: Investigating the effect of flash glucose monitoring and telehealth Rapid Access Diabetes Service (RADS) compared to self monitoring blood glucose (SMBG) checking and face to face appointments on the glucose levels of adults with diabetes who are undergoing discharge from an acute care hospital.
Secondary ID [1] 303731 0
None
Universal Trial Number (UTN)
Trial acronym
Flash RADS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Diabetes 321171 0
Glucose instability 321173 0
Condition category
Condition code
Metabolic and Endocrine 318974 318974 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Freestyle Libre glucose monitoring (inserted into the upper arm) paired with Telehealth consultations in people with diabetes who are undergoing discharge from an acute care hospital. Each participant will be shown how to connect to video conferencing while they are in hospital and sent the link to their personal email address for a trial connection prior to discharge. All participants will be provided with training by a Diabetes Educator on insertion of the Libre sensor. The Freestyle Libre sensor will be worn for 2 weeks then changed to a new sensor. Participants will be asked to wear 2 sensors (for 1 month) during the study period. Participants will also be asked to scan the sensor prior to each main meal and before bed and record the BGLs in a diary. The glucose data will be downloaded at the end of each 2 week period.
The intervention will be conducted under the guidance of a Senior Endocrinologist with over 20 years experience in diabetes management.
Both study groups will have seven study visits over nine weeks at a teaching hospital providing tertiary level ambulatory diabetes care. Usual standard of care (outside of pandemic health directives) would be face to face visits. This study will provide information on the effectiveness of telehealth compared to standard care.
Study visits for participants randomised to Telehealth
Visit 1: Participants will be recruited prior to discharge from hospital.
Visit 2: On the day of discharge, a glucometer and an appointment for randomisation will be provided.
Visit 3: One week after discharge from hospital, participants be randomised at a face to face. If randomised to Freestyle Libre (Flash) and telehealth, participants will receive training on how to connect to videoconferencing for telehealth visits.
Visit 4 to 6: On three occasions at week 2, 3 and 5 after discharge, participants will be asked to connect for the telehealth reviews via videoconferencing. They will not attend in-person face to face appointments during this time. Telehealth consult duration will be 30-40 minutes. The consult will consist of glucose data review for the previous week, hypoglycaemia review and medication changes made as clinically indicated.
Glucose graphs will be reviewed to monitor for adherence to the scanning of the glucose sensor.
Visit 7: Seven weeks after discharge, the participant will attend a face to face end of study visit for BGL review.
Intervention code [1] 320043 0
Treatment: Devices
Intervention code [2] 320262 0
Treatment: Other
Comparator / control treatment
Group 2: Standard Self Measured Blood Glucose (SMBG) monitoring using the Optium Freestyle Neo glucometer plus blinded Freestyle Libre PRO with traditional face-to-face clinic visits,
Optium Neo: People treated with insulin are asked to monitor BGLs using a glucometer. The Optium Freestyle Neo will be used by participants to limit glucose differences caused by different meter technologies. Participants will be asked to check BGLs before each main meal and before bed and record the results in a diary.
Libre PRO: The Freestyle Libre PRO checks BGLs but participants are blinded to the results. The PRO sensor will be applied by the study coordinator at face to face visits.
Visits: Participants will attend five face to face study visits after discharge from hospital at week 1, 2, 3, 5 and 7. The study visits will range from 30-40 minutes duration. Face to face study visit will consist of glucose review for the previous week (both diary and Neo download), hypoglycaemia review and medication changes made as clinically indicated. Participants will see the study coordinator and Senior Endocrinologist at each study visit.
Control group
Active

Outcomes
Primary outcome [1] 326886 0
Change in Time In Range of glucose levels assessed by Senior Endocrinologist.
Both Freestyle Libre (unblinded) and Freestyle Libre PRO (blinded) record time in range and these graphs will be the basis for between group comparison.
Timepoint [1] 326886 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [1] 393000 0
Change in estimated HbA1c (eHbA1c) assessed by Senior Endocrinologist from the data generated from the Freestyle Libre reports,
Timepoint [1] 393000 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [2] 393001 0
Standardised, department devised questionnaires of patient satisfaction and acceptability assessed by Senior Endocrinologist
Timepoint [2] 393001 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [3] 394183 0
Time in hypoglycaemia assessed by Senior Endocrinologist from the data generated from the Freestyle Libre reports,
Timepoint [3] 394183 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [4] 394184 0
Low Blood Glucose Level (LBGL) assessed by Senior Endocrinologist from the data generated from the Freestyle Libre reports,
Timepoint [4] 394184 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [5] 394185 0
Glucose CV assessed by Senior Endocrinologist from the data generated from the Freestyle Libre reports,
Timepoint [5] 394185 0
Baseline, 5 weeks after discharge and 7 weeks after discharge (final study visit).
Secondary outcome [6] 394186 0
Standardised, department devised questionnaires clinician satisfaction and acceptability assessed by Senior Endocrinologist
Timepoint [6] 394186 0
5 weeks after discharge (visit 4)

Eligibility
Key inclusion criteria
1. Either type 1 or type 2 diabetes.
2. Inpatients with glucose instability in hospital defined as:
a. Glucose readings over 15.0mmol/L on at least two separate occasions, and/or
b. A glucose reading under 4.0mmol/L on at least one occasion.
3. Require insulin therapy and follow-up at the RPAH Diabetes Centre RADS clinic after discharge.
4. Over 18 years of age.
5. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those who cannot use the Flash technology after having received training.
2. Those not able or willing to use telehealth.
3. People with severe hypoglycaemia in the last 3 months.
4. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
5. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements.
6. Participants requiring X-ray, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high frequency electrical heat (diathermy) treatment during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
20/06/2022
Date of last participant enrolment
Anticipated
5/04/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18943 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 33452 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308138 0
Commercial sector/Industry
Name [1] 308138 0
Abbott Diabetes Care
Country [1] 308138 0
United States of America
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Diabetes Centre
Royal Prince Alfred Hospital
Level 6 West Wing
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 308901 0
None
Name [1] 308901 0
Address [1] 308901 0
Country [1] 308901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308124 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 308124 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
RPA Medical Centre
Suite 306
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 308124 0
Australia
Date submitted for ethics approval [1] 308124 0
15/01/2021
Approval date [1] 308124 0
23/04/2021
Ethics approval number [1] 308124 0
X21-0009

Summary
Brief summary
Group One: Freestyle Libre blood glucose sensors and consults using telehealth
Group Two: Freestyle Libre PRO combined with Freestyle Optium Neo blood glucose finger prick monitoring and face to face study visits.

Aim: To compare Flash Libre glucose monitoring paired with Telehealth consultations versus standard SMBG monitoring with face-to-face clinic visits in people with diabetes who are undergoing discharge from hospital.

Hypothesis: That, in at least 60 people with type 1 and type 2 diabetes who are being discharged from Royal Prince Alfred Hospital (RPAH) on insulin treatment, those randomised to the Freestyle Libre (Flash) will have favourable effect on glucose levels (time in range (TIR), estimated HbA1c (eHbA1c), hypoglycaemia frequency and glucose variability) compared to the traditional finger prick BGL group over a seven week period after discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109622 0
Dr Ted Wu
Address 109622 0
Diabetes Centre
Royal Prince Alfred Hospital
Level 6 West Wing
Missenden Road
Camperdown NSW 2050
Country 109622 0
Australia
Phone 109622 0
+61 0295155888
Fax 109622 0
Email 109622 0
ted.wu@health.nsw.gov.au
Contact person for public queries
Name 109623 0
Ms Amanda Gauld
Address 109623 0
Diabetes Centre
Royal Prince Alfred Hospital
Level 6 West Wing
Missenden Road
Camperdown NSW 2050
Country 109623 0
Australia
Phone 109623 0
+61 0295155888
Fax 109623 0
Email 109623 0
amanda.gauld@health.nsw.gov.au
Contact person for scientific queries
Name 109624 0
Dr Ted Wu
Address 109624 0
Diabetes Centre
Royal Prince Alfred Hospital
Level 6 West Wing
Missenden Road
Camperdown NSW 2050
Country 109624 0
Australia
Phone 109624 0
+61 0295155888
Fax 109624 0
Email 109624 0
ted.wu@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.