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The artificial pancreas in children aged 1 to 7 years with type 1 diabetes

Periodic Reporting for period 4 - KidsAP (The artificial pancreas in children aged 1 to 7 years with type 1 diabetes)

Reporting period: 2021-01-01 to 2021-12-31

Type 1 diabetes is one of the most common chronic diseases in children with a rapid increase in the number of cases, particularly in young children. Type 1 diabetes is associated with life-long dependency on insulin administration to control glucose levels. Poor glucose control leads to diabetes complications such as disease of the eyes, heart and kidneys. Poor glucose control is also associated with brain changes in young children. Episodes of very low glucose levels may be life-threatening and are a major complication.

The artificial pancreas addresses the problem of low and high glucose levels by delivering insulin below and above pre-set amounts according to real-time sensor glucose levels. The artificial pancreas combines a glucose sensor, insulin pump and control algorithm on an android phone. This technology promises to transform the management of type 1 diabetes, but evidence supporting its use during free-living in young children is missing. This project evaluates the biomedical, psychosocial, and cost-effectiveness of this novel, individualised, artificial pancreas in young children aged 1 to 7 years with type 1 diabetes.

Initially, a pilot study was conducted in 7 clinical centres in Europe. 24 young children aged 1 to 7 years with type 1 diabetes were recruited into the clinical study and wore the artificial pancreas for two periods of 3 weeks, once using standard strength insulin and once using diluted insulin. The results of the study were published in Diabetes Care (https://doi.org/10.2337/dc18-1881). Following the pilot study, the main outcome study will be conducted in 7 clinical centres in Europe. 72 children aged 1 to 7 years with type 1 diabetes will be treated over two four-month periods, once using the artificial pancreas, and once using sensor-augmented insulin pump therapy. The total length of the study will be 11 months. Quality of life will be assessed and semi-structured interviews conducted to understand the impact on daily life. A health technology assessment will be carried out to support reimbursement.

The project will optimise the artificial pancreas and spearhead system-wide improvements in health care quality and health outcomes in young children with type 1 diabetes who live with the disease the longest. By improving therapeutic outcomes, the project will change clinical practice and influence national and international treatment guidelines making the artificial pancreas widely acceptable as the state-of-the-art treatment modality in this population.
The pilot clinical study (KidsAP01) has been completed. The study compared the use of diluted and standard strength insulin in the artificial pancreas in children aged 1 to 7 years with type 1 diabetes. The study also assessed the safety, efficacy and utility of the artificial pancreas in this age group. The primary manuscript was published in Diabetes Care (https://doi.org/10.2337/dc18-1881) a lay summary is available on the KidsAP project website (http://kidsap.mrl.ims.cam.ac.uk). The results of the pilot study informed the design of the main outcome study.

The KidsAP02 clinical study has been completed. During the 4 months when children used the closed-loop system, their glucose levels were in the target range an extra 2.1 hours per day, compared to when they used only insulin pump and glucose sensor. They spent 72% of their day with glucose levels in the target range (3.9 to 10.0mmol/L) using closed-loop, compared to 63% using pump and sensor. At the end of each 4-month period, all children had their HbA1c measured, which looks at overall blood glucose control over the previous 3 months. After children used the closed-loop system, their HbA1c was 4mmol/mol lower than when they used pump and sensor. We know that a lower HbA1c reduces the risk of long-term diabetes complications like kidney, heart and eye disease.
High glucose levels can affect brain growth and learning in young children with T1D. In the study, children spent 32% of their day with high glucose levels when using pump and sensor, but this was reduced to 23% when using closed-loop. Low glucose levels can be dangerous too, but children spent no extra time with low glucose levels when they used closed-loop.
When children used the closed-loop system, their glucose levels were most stable overnight, with more than 80% of glucose levels in the target range. Parents of children with T1D often sleep poorly because they have to get up to check glucose levels or give insulin. Using closed-loop kept glucose levels more stable at night, which could help to improve parents’ sleep.

The primary manuscript was published in the New England Journal of Medicine : https://www.nejm.org/doi/full/10.1056/NEJMoa2111673?query=featured_endocrinology and the University of Cambridge released a press release: https://www.cam.ac.uk/stories/KidsArtificialPancreas.

Together with Digibete, an NHS-funded video platform, we are creating videos that show the results of the KidsAP02 study. These videos will be shared with families, healthcare professionals and the public to help spread the message about closed-loop and its benefits for very young children.
This year, the National Institute for Clinical Excellence (NICE), is publishing new guidelines on closed-loop and they will make recommendations on whether it should be available on the NHS. We have shared the study results with NICE and hope that the new guidelines will make closed-loop more accessible for children and their families.
The project advances the state-of-the-art both technologically and clinically whilst mitigating against risks through extensive clinical and engineering experience and expertise of the collaborators.

The complications associated with hyperglycaemia and hypoglycaemia in type 1 diabetes carry high societal and medical costs. Educational interventions in youth are failing and immunotherapy struggles in clinical translation. Nearly 1 in 10 admissions to hospital of children with diabetes is a result of a hypoglycaemic episode. Diabetes complications lead to increased risk of mortality in type 1 diabetes by 130% compared to 35% in type 2 diabetes.

The 24/7 use of the Artificial Pancreas in the home/outpatient settings in young children is groundbreaking. No outpatient studies in this population cohort have been reported. Remote functionality and alarming has been studied but not connected to industry-standard cloud infrastructure or allowing parents/ guardians/ carers to receive alarms during closed-loop use. The free-living use of the Artificial Pancreas in the home settings has been reported in children aged 6 to 12 years (children aged 10 years and older and adults by the Consortium members (CAM, GRA, and LUX) over 2 days to 3 weeks.) The main KidsAP02 study will evaluate the Artificial Pancreas in the home settings over longer clinically desirable duration.

We will reduce the risk of hypoglycaemia and improve long term outcomes through the use of the closed-loop system and remote alarm functionality. The two interlinked clinical investigations will provide a deeper understanding of effectiveness, efficacy, safety beyond the state-of-the-art of the current knowledge surrounding the Artificial Pancreas and glucose control in young children.
CamAPS FX closed loop system to be used in the main outcome study
A KidsAP01 Cambridge participant wearing the closed loop system
A KidsAP01 Graz participant wearing the closed loop system