Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000024549
Ethics application status
Approved
Date submitted
29/11/2023
Date registered
11/01/2024
Date last updated
7/04/2024
Date data sharing statement initially provided
11/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating continuous glucose monitoring and metabolic profiles in adults with Cystic Fibrosis Related Diabetes (CFRD).
Scientific title
A randomised cross-over trial evaluating glycaemic, clinical and psychometric effects associated with the use continuous glucose monitoring (CGM) in adults with Cystic Fibrosis Related Diabetes (CFRD).
Secondary ID [1] 311038 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis related diabetes 332155 0
insulin deficiency 332181 0
metabolic health 332182 0
Condition category
Condition code
Metabolic and Endocrine 328875 328875 0 0
Diabetes
Respiratory 328876 328876 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 328877 328877 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a single-centre, open-label prospective, randomized crossover trial with an embedded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluation framework. The trial will randomize eligible participants with confirmed cystic fibrosis (CF)-related diabetes on insulin to compare continuous glucose monitoring (CGM) with the Freestyle Libre 2 system with standard care (fingerstick blood glucose monitoring) with cross over at 3-months.

The Freestyle libre 2 continuous glucose monitoring device (Abbott Diabetes) is approved for use in people with diabetes on insulin and forms part of standard clinical care for all people above 4 years of age living with type 1 diabetes in Australia. This device will be used according to manufacturer instructions in adults with confirmed cystic fibrosis related diabetes and compared to fingerstick blood glucose monitoring.

The CGM consists of a sensor and reader. The sensor is encompassed within a sterile application device that is designed to be inserted independently by the person wearing the CGM. The sensor (size of a 20-cent coin) is applied to the back of the upper arm and involves the insertion of a thin, flexible, sterile fibre (5mm long) into the subcutaneous tissue where it remains in-situ for 14 days. The reader is an application that can be downloaded onto a Smartphone which enables it to function as a reader when scanned over the sensor. The Freestyle Libre 2 system records an interstitial glucose reading every 10-15 minutes. The sensor system is kept in place by an adhesive. This CGM system has been validated for use in people with CF. Sensor usage metrics will be used to provide information on engagement of the individual wearing CGM with the system.

CGM onboarding will be provided by a credentialed diabetes educator using face-to-face and/or online educational resources. There will be no washout period.
Intervention code [1] 327483 0
Treatment: Devices
Comparator / control treatment
Standard care of CF-related diabetes which includes multiple daily fingerstick blood glucose monitoring. This includes usually 3-4 fingerstick blood glucose checks per day prior to breakfast, lunch, dinner and before bed. Participants will be asked to keep a logbook of recorded BGLs
Control group
Active

Outcomes
Primary outcome [1] 336682 0
Primary outcome will be change from baseline to follow-up in Hemoglobin A1c (HbA1c) between continuous glucose monitoring and standard care.

Timepoint [1] 336682 0
Checked at baseline (0 months), cross-over (3-months) and study end (6 months)
Secondary outcome [1] 429323 0
Diabetes distress
Timepoint [1] 429323 0
0 months, 3 months and 6 months after the start of the study
Secondary outcome [2] 429389 0
RE-AIM implementation outcomes
Timepoint [2] 429389 0
post-trial follow-up within 1 month after trial completion
Secondary outcome [3] 430021 0
hypoglycaemic anxiety
Timepoint [3] 430021 0
0 months, 3 months and 6 months after the start of the study
Secondary outcome [4] 430022 0
Glucose monitoring satisfaction
Timepoint [4] 430022 0
0 months, 3 months and 6 months after the start of the study
Secondary outcome [5] 430023 0
RE-Aim Implementation outcomes
Timepoint [5] 430023 0
post-trial follow-up within 1 month after trial completion
Secondary outcome [6] 430024 0
RE-Aim Implementation outcomes
Timepoint [6] 430024 0
post-trial follow-up within 1 month after trial completion
Secondary outcome [7] 430025 0
RE-Aim Implementation outcomes
Timepoint [7] 430025 0
post-trial follow-up within 1 month after trial completion
Secondary outcome [8] 430026 0
RE-AIM Implementation outcomes
Timepoint [8] 430026 0
post-trial follow-up within 1 month after trial completion

Eligibility
Key inclusion criteria
• Age of >21 years
• On insulin therapy
• Confirmed CFRD based on current ADA criteria
• Most recent HbA1c above the target of 7.0%
• Participant being able to complete the study protocol
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to use Smartphone application
• Unable to self-insert CGM
• Incompatible Smartphone
• Lacking capacity to engage in all aspects of study protocol

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25895 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 41730 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 315693 0
Charities/Societies/Foundations
Name [1] 315693 0
Cystic Fibrosis Australia Diabetes & Innovation Grant
Country [1] 315693 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Services
Address
Block 7, Level 7, Royal brisbane and Women's Hospital, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 317369 0
None
Name [1] 317369 0
Address [1] 317369 0
Country [1] 317369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314222 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 314222 0
Ethics committee country [1] 314222 0
Australia
Date submitted for ethics approval [1] 314222 0
04/12/2023
Approval date [1] 314222 0
15/01/2024
Ethics approval number [1] 314222 0
HREC/2023/MNHB/104428;

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130838 0
Dr Shanal Kumar
Address 130838 0
Adult Cystic Fibrosis Centre, Jacaranda Drive, The Prince Charles Hospital, Chermside 4032
Country 130838 0
Australia
Phone 130838 0
+610731394770
Fax 130838 0
Email 130838 0
shanal.kumar@health.qld.gov.au
Contact person for public queries
Name 130839 0
Shanal Kumar
Address 130839 0
Adult Cystic Fibrosis Centre, Jacaranda Drive, The Prince Charles Hospital, Chermside 4032
Country 130839 0
Australia
Phone 130839 0
+610731394770
Fax 130839 0
Email 130839 0
shanal.kumar@health.qld.gov.au
Contact person for scientific queries
Name 130840 0
Shanal Kumar
Address 130840 0
Adult Cystic Fibrosis Centre, Jacaranda Drive, The Prince Charles Hospital, Chermside 4032
Country 130840 0
Australia
Phone 130840 0
+61073139 4770
Fax 130840 0
Email 130840 0
shanal.kumar@health.qld.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.