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Closed-Loop Insulin Delivery Systems 'Effective' in Children

Closed-loop insulin delivery systems, designed to automate aspects of diabetes management in children and teenagers, yielded significantly higher blood glucose time in range for children with type 1 diabetes than standard diabetes care, according to results from a meta-analysis presented at the Endocrine Society's annual meeting in Chicago, Ill.

Although the first closed-loop (CL) system was approved for paediatric use in 2020, and the technology had been subject to numerous randomised clinical trials, there had previously been no meta-analysis evaluating the effect of prolonged use of CL systems on glycaemia in children and adolescents with type 1 diabetes mellitus (T1DM), explained researcher Amanda Godoi, a fourth-year medical student at Cardiff University. 

The study set out to compare the therapeutic efficacy and safety of long-term use of CL insulin delivery systems with standard care in paediatric patients with T1DM. The major databases (PubMed, Cochrane, and EMBASE) were searched in October 2022 for randomised controlled studies of least 12 weeks' duration comparing CL (automated pancreas, hybrid CL, and advanced hybrid CL) versus standard care (daily insulin injections, sensor augmented pumps, and continuous glucose monitoring), which is not automated and thus requires the patient to monitor blood glucose levels and adjust insulin accordingly.

The search yielded seven studies involving a total of 827 patients with T1DM, of whom 471 (56.7%) used automated devices and 356 (43.3%) continued their usual care.

Superior Blood Glucose Results with Closed Loop Systems

Results of the meta-analysis, showed that the percentage time in range (% TIR: 70-180mg/dL) was significantly higher with the CL systems compared with standard care (mean difference 8.70%; 95% CI 7.08 to 10.31; P< 0.001; I²=0%). Similarly, CL systems yielded a significantly higher change in HbA1c: mean difference compared with standard care -0.38 (95% CI -0.59 to -0.16; P< 0.001; I²=0%) – "a small but important difference", according to the presentation.

Percentage time with hypoglycemia was also lower with CL systems compared with SC, but the mean difference (-0.47%; 95% CI -1.06 to 0.13; P=0.12; I²=55%) did not reach statistical significance. 

The benefits of CL systems were achieved without increasing the risk of adverse effects such as hypoglycemia and diabetic ketoacidosis and the study concluded: "CL systems seem to be safe and superior to standard care regarding glycemic control." 

Ms Godoi said: "Treatment of type 1 diabetes in children is a clinical challenge. We found using closed-loop systems led to improved glucose control, which represents an important treatment opportunity to reduce complications and morbidity in children with type 1 diabetes.

"Our results show that closed-loop technology seems to be safe and superior to usual care in controlling glucose levels." 

Living With Diabetes a 'Relentless Balancing Act'

Asked to comment on the study by Medscape News UK, Nikki Joule, policy manager at Diabetes UK, said: "Living with diabetes is a relentless balancing act, and people with type 1 diabetes deal with the burden of managing their condition day in, day out. 

"Hybrid closed-loop technology has the potential to transform the lives of people with type 1 diabetes – particularly for children and their families – improving both clinical outcomes and their quality of life. It's so important that people have access to the technologies they can benefit from most, helping them to manage their diabetes, avoid complications and live well with the condition."

Also commenting to Medscape News UK, Dr Tabitha Randell, chair of the British Society for Paediatric Endocrinology and Diabetes, said: "Hybrid closed loop systems have been a game changer in improving outcomes and quality of life for children and young people with diabetes. 

"The meta-analysis presented at the ENDO meeting has demonstrated that they are safe and effective, and it is worth bearing in mind that many of these published studies were done using systems that have been significantly improved since the original results came out. 

"Whilst we still do not have a cure for diabetes, hybrid closed loop systems offer the chance for children and young people to truly fit their diabetes around them rather than the other way round. Not every young person will want to use such a system, but it is important that they are given that choice to help ensure having diabetes is not a barrier to them achieving whatever they want to in their lives."