Closed loop in children and youth with type 1 diabetes
People living with type 1 diabetes have the life-long burden of managing their blood glucose levels. To reduce the burden of this disease and improve health outcomes for people living with type 1 diabetes, researchers are focusing their efforts on automating blood glucose monitoring and insulin delivery through "closed loop therapies".
Closed loop therapies use algorithms to recognise blood glucose concentrations from a continuous glucose monitor (CGM) and respond automatically by pumping the appropriate dose of insulin through an automated insulin pump.
The Co-pilot Trial study design
Aim of the study: The Co-pilot study aims to identify if advanced hybrid closed loop (AHCL) system (MiniMed™ 780G) is an appropriate and safe therapy for those struggling with healthy diabetes control.
Participants: 80 children and youth in Aotearoa New Zealand aged 7-25 years old with less healthy type 1 diabetes control. This cohort of youth are often excluded from clinical trials, but they have a high risk of developing long term complications from their diabetes such as blindness, lower limb amputation and early death.
Study design: Randomised control trial with 37 youth randomized to the treatment arm and 43 randomized to the control arm. Youth enrolled in the treatment arm of the study received an insulin pump and a continuous glucose monitor for automated insulin delivery. Control participants received usual diabetes care of multiple injections or non-automated pump therapy.
Outcomes: While better control of glucose levels were key outcomes for this trial, other features such as burden reduction, improved quality of life and treatment satisfaction was also explored.
Main findings after 12 weeks
Participants who received automated insulin delivery (treatment group):
- Spent an average of 8.4 hours more per day in the normal blood sugar range, compared with those youth receiving usual diabetes care.
- Spent 23 minutes less time per day within the hypoglycaemic range (low blood sugar levels), compared to those youth receiving usual diabetes care.
- Reported no diabetic related adverse events.
Conclusions and what's next?
This short-term trial in 80 children and youth showed that automated insulin delivery appeared effective at improving blood glucose control in youth with less healthy type 1 diabetes. Furthermore this therapy appeared to be safe for use in these youth who received appropriate support during the intervention.
To see whether the effects observed at 3 months can be sustained over a longer time period, the Co-Pilot trial will complete a further follow-up at 39 weeks. The authors of this trial also acknowledge that the Co-pilot Trial involved a relatively small sample of youth and conclude that larger studies with long term follow-up are needed to confirm the findings of this trial.
Study Funding
This study has received funding from Lions New Zealand District 202F, NZ Lottery Health Research Grant, Starship Foundation and charitable funds via Wayne Bowen and Family and the New Zealand Spinal Cord Research Society.
Publications and Media
- Automated Insulin Delivery for Young People with Type 1 Diabetes and Elevated A1c, The New England Journal of Medicine Evidence, 24 September, 2024
- Getting Diabetes Technologies into the Hands of Those Who Need Them Most, The New England Journal of Medicine Evidence, 24 September, 2024
- Automated insulin pump trial "life-changing", University of Otago, 26 September, 2024
- Continuous glucose monitors 'life-changing' for children with type 1 diabetes, RNZ, 29 September, 2024
- Engagement barrier to uptake, ODT, 2 October, 2024
Contact the EDOR Researchers
| Department of Women's and Children's Health, University of Otago | ||
| Department of Women's and Children's Health, University of Otago |