None listed
Conditions
Brief summary
Following a heart or lung transplant, medications required to prevent rejection increase the risk of developing post-transplant diabetes mellitus. In many individuals, insulin treatment is required to maintain normal glucose levels and prevent diabetes related complications. Insulin treatment is complex and requires self-monitoring of blood glucose levels using fingerprick testing to avoid prolonged periods of high or low glucose levels. This study aims to determine if continuous glucose monitoring increases the amount of time blood glucose levels are maintained within the normal range compared to standard fingerprick glucose testing.
Interventions
During the study, participants will complete 8-weeks of continuous glucose monitoring using the Freestyle Libre2+ and Freestyle Libre PRO iQ glucose monitoring systems. Devices will be applied to the back of the non-dominant arm as per manufacturer's instructions using the sensor applicator. The process is painless.
In one 4-week period participants will be able to see their glucose levels in real-time and adjust insulin dosing and food intake accordingly (Libre 2+). During the other 4-week pe
During the study, participants will complete 8-weeks of continuous glucose monitoring using the Freestyle Libre2+ and Freestyle Libre PRO iQ glucose monitoring systems. Devices will be applied to the back of the non-dominant arm as per manufacturer's instructions using the sensor applicator. The process is painless. In one 4-week period participants will be able to see their glucose levels in real-time and adjust insulin dosing and food intake accordingly (Libre 2+). During the other 4-week period, participants will be blinded to continuous glucose monitoring and be required to monitor their glucose levels in the usual fashion using fingerprick capillary blood and point-of-care glucometer testing (Libre PRO iQ). Adherence will be measured using the LibreLink associated mobile phone application, which records "time worn" for each sensor based on the time glucose levels are being recorded during a standard 14-day wear. The order in which participants complete the blinded and unblinded phases of continuous glucose monitoring will be allocated randomly. There is no washout period between the two sensor phases, and phase 2 will immediately follow phase 1.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
a) Age greater than 18 years. b) Diagnosis of diabetes mellitus. c) Treatment with subcutaneous insulin (greater than 10 units per day). d) Stable insulin dose for at least 6 weeks prior to study enrolment. e) More than 1-year since heart or lung transplant
Exclusion criteria
a) Current or recent continuous glucose monitor use (within 3 months of enrolment). b) Recent organ rejection (within 6 months of enrolment) or unstable immuno-suppression doses (within 3 months of enrolment). c) Vitamin C supplementation with doses greater than 500 mg per day.
Outcome results
None listed