None listed
Conditions
Brief summary
Flash continuous glucose monitoring (FGM) technology, could increase glucose monitoring and in turn diabetes control among children with T1D. FGM users attach a small sensor to their arm to monitor interstitial glucose levels. The sensor is worn for up to 2 weeks. They scan the sensor with a reader, which immediately displays 1) their current interstitial glucose level, as well as 2) a graph of retrospective glucose data for the previous 8 hours and 3) a glucose trend prediction arrow. Both retrospective and predicted glucose trends are not available with SMBG technology. FGM, therefore, can provide accurate and up-to-date glucose information, as well as being user-friendly (simple to scan the sensor, no limit to scanning frequency), provide rapid results and be discrete (scanning through clothing etc.); all allowing for marked increase frequency of testing. We will conduct a randomized controlled trial to determine whether FGM can improve diabetes control in children with T1D aged 4-13, inclusive, who are not currently achieving adequate diabetes control. It is hypothesized at 12 weeks there will be a 7 mmol/mol greater improvement (reduction) in glycaemic control (HbA1c) in the intervention group compared to the change in glycaemic control in the control group
Interventions
Flash glucose monitoring provides accurate and up-to-date glucose data and can be used as a replacement for finger-prick blood glucose monitoring. The flash glucose monitoring system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 14 days, which is scanned by a hand-held reader to display glucose data. Glucose data includes the current glucose level, predicted glucose trend, and a graph of glucose levels from the previous 8 hours. At the baseline study vis
Flash glucose monitoring provides accurate and up-to-date glucose data and can be used as a replacement for finger-prick blood glucose monitoring. The flash glucose monitoring system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 14 days, which is scanned by a hand-held reader to display glucose data. Glucose data includes the current glucose level, predicted glucose trend, and a graph of glucose levels from the previous 8 hours. At the baseline study visits, participants randomized to the intervention group will receive a 12-week supply of sensors (6 sensors) and approximately 30 minutes of face-to-face education by trained staff (a research nurse with diabetes knowledge) based on the manufacturer's users guide on how to apply sensors and interpret glucose data for informing treatment decisions. Participants will be instructed to scan a minimum of 10 times each day and parents will be instructed to scan at least one time per night (after 9 PM). Adherence to scanning recommendations will be monitored from data downloaded from the flash glucose monitoring system. 14 days from the start of flash glucose monitoring (the day the first sensor change is due) participants or a parent/guardian will apply the new sensor under the supervision of trained staff and apply all sensors on their own for the remainder of the study. Participants in this group will also receive an additional 30 minutes of education on scanning, trends, and hypoglycaemia treatment.
Sponsors
Starship Children’s Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 4 to less than or equal to 13 years; 2. A diagnosis of T1D for 6 months or longer duration; 3. Current HbA1c greater than or equal to 58 mmol/mol and less than or equal to 110 mmol/mol; 4. On an insulin dose per day > 0.05 units of insulin/kg/day; 5. No regular use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) in the previous 3 months.
Exclusion criteria
There will be no restriction on insulin regimen. 1. Any severe chronic diabetes-related complications; 2. Severe medical or psychiatric co-morbidity/severe mental illness; 3. Participation in another study that could affect glucose measurements; 4. Plans to leave study site regions prior to study completion; 5. Regular continuous use of FGM or CGM; 6. HbA1c > 110mmol/mol.
Outcome results
None listed