None listed
Conditions
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 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
Study design
Eligibility
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