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Evaluating continuous glucose monitoring and metabolic profiles in adults with Cystic Fibrosis Related Diabetes (CFRD).

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).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000024549
Enrollment
36
Registered
2024-01-11
Start date
2024-05-20
Completion date
2024-12-31
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In the era of disease-specific treatments improving life expectancy for adults with Cystic Fibrosis (CF), we face new challenges in their metabolic health. Our project focuses on the highest-risk group, specifically adults with CF-related diabetes. We will use continuous glucose monitoring to gather detailed blood sugar data, along with body metrics, clinical information and patient-reported outcomes. Research evidence will be used to advocate for access to diabetes technology, inform management to prevent diabetes-related complications, and profile metabolic status. This endeavor will deliver novel insights that will also be foundational in informing strategies to optimise metabolic health in this population.

Interventions

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 continuo

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.

Sponsors

Metro North Hospital and Health Services
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

• Unable to use Smartphone application • Unable to self-insert CGM • Incompatible Smartphone • Lacking capacity to engage in all aspects of study protocol

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026