None listed
Conditions
Brief summary
Managing diabetes in a ‘flash’ is a mixed-methods study exploring a novel flash glucose monitoring (FGM) system among adolescents with poorly controlled type 1 diabetes (T1D). 64 paediatric participants with T1D will be recruited from Canterbury, Capital and Coast, South Canterbury, and Southern District Health Board diabetes clinics. Participants in the FGM group (n=32) will be given a FreeStyle Libre reader, a 12-month supply of sensors, and access to FreeStyle Libre software. The waitlist control group (n=32) will continue usual standard care for the first six months of the study. At six months, the waitlist control group will crossover and be provided a FreeStyle Libre reader, a six-month supply of sensors, and access to FreeStyle Libre software. All participants in the FGM group, and their caregivers, will be invited to one-to-one interviews to explore their experiences with the FGM.
Interventions
The FreeStyle Libre flash glucose monitoring (FGM) system (reader, sensor, software) plus usual care, will be provided to the intervention group for the duration of the trial period (12 months in total: 6-month RCT, followed by a 6-month continuation study).
To use the FGM, a thin sensor is inserted into the back of one arm, which relays the patient's current interstitial glucose levels to a handheld reader when the reader is held next to the sensor. The sensor must be replaced every 14 days du
The FreeStyle Libre flash glucose monitoring (FGM) system (reader, sensor, software) plus usual care, will be provided to the intervention group for the duration of the trial period (12 months in total: 6-month RCT, followed by a 6-month continuation study). To use the FGM, a thin sensor is inserted into the back of one arm, which relays the patient's current interstitial glucose levels to a handheld reader when the reader is held next to the sensor. The sensor must be replaced every 14 days during the trial period. During the baseline study visit, the first FreeStyle Libre sensor will be applied by trained staff (i.e., diabetes nurse or research staff trained by a FreeStyle Libre distributor territory manager) using the manufacturer’s quick start guide. Patients will be instructed to follow the manufacturer's guidelines for using the FGM system and will be given brief education on using the system. As a safety precaution, participants will be advised to perform finger stick blood glucose level measurements to confirm their blood glucose level before therapeutic interventions or corrective action if hypo- or hyperglycaemic glucose levels or symptoms occur. Fourteen days after the initial visit, participants will return to the clinic for an inspection of the insertion site and be supervised applying a sensor on their own. Participants will be asked to report any adverse events (skin reactions to the sensor and/or adhesive, severe hypoglycaemic events, DKA, hospital admissions) during this visit and will be sent an electronic survey to report adverse events every 14 days thereafter. At the 6-month visit, all participants will be provided FGM supplies and those who consent to an adhesive sub-study will be randomised to one of two groups. Group 1 will receive a 3-month supply of pre-cut sports tape to place over each sensor. Group 2 will be instructed to use no products to prevent sensor loss. At the 9-month visit participants in the adhesive sub-study will cross over to the other group. All diabetes care will be as per standard clinic care, with the study only providing support for technical issues with the device. Glucose readings will be downloaded during routine clinic visits to be reviewed by a paediatric endocrinologist and during study visits to download retrospective glucose data for analysis. Data from each participant's FreeStyle Libre glucose monitoring system will also be used to monitor adherence to the intervention (eg, frequency of sensor scanning).
Sponsors
Department of Women's and Children's Health, DSM
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
1) aged 13 to 20 years, inclusive; 2) diagnosed with T1D for at least 12 months; 3) mean HbA1c of >= 75 mmol/mol over the past 6 months; 4) >0.5 units of insulin/kg/day (with no restrictions based on insulin regimen); 5) plans to continue with routine clinical care during the 6-month study; 6) currently residing in and expecting to remain in regions served by the Canterbury, Capital and Coast, South Canterbury, and Southern District Health Boards for the following year; 7) the ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion criteria
1) Any severe diabetes related complications (nephropathy on treatment, retinopathy with associated visual loss – milder degrees will not be excluded); 2) Other severe uncontrolled medical or psychiatric co-morbidity/severe mental illness; 3) currently using a CGM device or has used one continuously (other than for intermittent hospital use) within the previous 4 months; 4) participation in another device or drug study that could affect glucose measurements during the study period; 5) pregnancy, lactation, or plans to become pregnant; 6) inability of individual or legal guardian to give written informed consent.
Outcome results
None listed