None listed
Conditions
Brief summary
Currently we are not meeting glycaemic targets using standard care models. This provides the opportunity to review models of care to maximise outcomes. The use of continuous glucose monitor (CGM) data to detect changes in glycaemic control provides an opportunity to adapt our model of care to deliver more personalised and targeted care for young people with diabetes. This trial will test a new model of care, aiming to use CGM data to detect early adverse changes in glycaemic control and provide targeted and tailored intervention to those individuals needing more intensive support. Aim: This study aims to investigate if using fortnightly review CGM for early identification of adverse markers in glycaemic control, with implementation of targeted intervention improves glycaemic outcomes and patient reported outcomes in children living with diabetes compared to those receiving care using the current standard model of care. Objectives: 1) To investigate if targeted intervention based on adverse glycaemic control on CGM metrics improves glycaemic control compared to standard models of care 2) To investigate if patient and family reported satisfaction and outcomes are improved with targeted intervention based on CGM metrics 3) To conduct cost-benefit analysis of targeted intervention compared to standard models of care 4) To conduct post study consultation with consumers and health care professionals for feedback on the study and relevant comments on next stages of digital dashboard development Hypothesis: 1. Using fortnightly review of digital CGM upload for early identification of adverse changes in glycaemic control with targeted personalised clinical intervention can improve overall glycaemic control and patient and family satisfaction compared to 3-monthly review at multidisciplinary appointments.
Interventions
Participants will be recruited from two age-matched clinical cohorts that attend Diabetes Outpatient Clinics at Perth Children's Hospital on different days.
All participants who attend their outpatient clinic on one day will be allocated to the participant group, those who attend on the alternate day will be allocated to control.
The allocation of clinic groups to intervention or control will be done randomly.
Participants will use their existing continuous glucose monitor (CGM) and their report
Participants will be recruited from two age-matched clinical cohorts that attend Diabetes Outpatient Clinics at Perth Children's Hospital on different days. All participants who attend their outpatient clinic on one day will be allocated to the participant group, those who attend on the alternate day will be allocated to control. The allocation of clinic groups to intervention or control will be done randomly. Participants will use their existing continuous glucose monitor (CGM) and their report will be reviewed every fortnight by the principal investigator (doctor) to identify "flags" of adverse blood glucose control. CGM data is accessed by clinicians logging onto device specific platforms where data is stored on a "cloud", access to this data is granted by families, who link their devices to the clinic account. Flags will be percentage time in range (3.9-10.0mmol/L) <50%, reduction in time in range >10%, percentage time below range (<3.9mmol/L) >4% and CGM percentage use <75%. Participants with one or more flags of adverse blood glucose control will be contacted via text message to offer a phone call from the study diabetes nurse educator or an email with educational resources provided. Text messages will be sent from a study specific mobile phone through WhatsApp messaging application. This application allows confirmation when messages are received and read and is secure with end to end encryption. For participants who request contact the diabetes nurse educator will review the CGM upload for the fortnight to identify glucose patterns. If the participant requests a phone call the educator will call the participant to provide diabetes management advice based on their upload review (time up to 20minutes). If the participant requests an email, a link to relevant education material from the Children's Diabetes Centre website will be provided (1-2 page document taking approximately 5 minutes to review). Participants who are identified to have positive glucose control including percentage time in range >70%, increase in time in range >10% will receive positive feedback via a text message. The intervention will repeat every two weeks over a six month period. Participants have the opportunity to opt out of contact from the team, this will be recorded. The intervention will occur in addition to the participants usual diabetes care.
Sponsors
Child and Adolescent Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
Children aged 5-14 years and their parents or primary caregivers CGM use greater than or equal to 75% of the time in the 2-week period leading up to study start Insulin administration via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Exclusion criteria
Children not using CGM
Outcome results
None listed