Dr Julia Ware (née Fuchs) Clinical Research Associate Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories  and Medical Research Council Metabolic Diseases Unit, University of Cambridge Addenbrooke’s Hospital, Cambridge 

Diabetes: Closed-Loop Artificial Pancreas Improved Glucose Control in Very Young Children

MedicalResearch.com Interview with:

Dr Julia Ware (née Fuchs) Clinical Research Associate Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories  and Medical Research Council Metabolic Diseases Unit, University of Cambridge Addenbrooke’s Hospital, Cambridge 

Dr. Ware

Dr Julia Ware
(née Fuchs)
Clinical Research Associate
Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories
and Medical Research Council Metabolic Diseases Unit, University of Cambridge
Addenbrooke’s Hospital, Cambridge

MedicalResearch.com: What is the background for this study?

Response: Management of type 1 diabetes is challenging in very young children, due to their high variability of insulin requirements and unpredictable eating and activity patterns. As a result, many young children do not meet the recommended glycemic targets, or only maintain recommended glycemic control with extensive caregiver input. This in turn leads to high management burden and reduced quality of life for the whole family.

While the increasing use of continuous glucose-monitoring devices and insulin-pump therapy has led to reductions in the incidence of severe hypoglycaemia and diabetic ketoacidosis, and has been accompanied by modest improvements in glycemic control, the burden of management has remained high. Hybrid closed-loop systems (also called an artificial pancreas), in which an algorithm automatically adjusts insulin delivery on the basis of real-time sensor glucose levels, may address ongoing challenges in this age group. However, to date hybrid closed-loop studies involving very young children have been small and of short duration and the efficacy and safety of longer term use of a closed-loop system, as compared with standard therapy, was unclear.  

To address this knowledge gap, we compared 16-week use of the Cambridge closed-loop algorithm with sensor-augmented pump therapy in children aged 1 to 7 years with type 1 diabetes in a multi-national randomised crossover study.

MedicalResearch.com: What are the main findings?  Any problems with infections or other adverse effects?

Response: ​74 children with an average age of 5.6 years took part in our study. We found that children spent an extra 2.1 hours per day with glucose levels in the target range (70 to 180mg/dL) using the closed-loop system, compared to sensor-augmented pump therapy. With closed-loop, time spent in the target glucose range was 72%, compared to 63% with sensor-augmented pump therapy. We also observed significant reductions in hyperglycaemia (time spent with glucose >180mg/dL was 23% with closed-loop vs 32% with sensor-augmented pump therapy), but importantly noted no increase in hypoglycaemia (time spent with glucose <70mg/dL) with closed-loop therapy. At the end of the closed-loop period, HbA1c was 0.4 percentage points (4mmol/mol) lower than after using sensor-augmented pump therapy. This is particularly significant given that study participants had a low baseline HbA1c, and a higher baseline HbA1c has been associated with greater reductions in HbA1c in other closed-loop studies. With closed-loop therapy, tight glucose control was most prominent overnight, with more than 80% of glucose levels in the target range, suggesting that closed-loop therapy may help to improve parents’ sleep. The time that the system was in the closed-loop mode was consistently high during the closed-loop period (median, 95% of the time), supporting longer-term usability in this age group.

Adverse event rates were similar between the two treatments. There was one severe hypoglycaemia event during the closed-loop period, which occurred as a result of a very low nocturnal glucose target set by the parents and parents not responding to hypoglycemia alarms over a 3-hour period prior to the event. One non-treatment related serious adverse event occured in the sensor-augmented pump period, where the participant was admitted to hospital with gastroenteritis. 

MedicalResearch.com: What should readers take away from your report?

Response: Our findings show that use of the Cambridge hybrid closed-loop system led to significant improvements in glycaemic control, without an increase in hypoglycaemia, in very young children with type 1 diabetes as compared to sensor-augmented pump therapy. The consistently high use of the closed-loop system suggests high acceptability of hybrid closed-loop therapy in this vulnerable population.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: This study supports the adoption of hybrid closed-loop therapy in routine clinical care for very young children with type 1 diabetes. Longer-term real-world studies are required to assess whether glycaemic and quality of life benefits are sustained long-term, which will help to inform reimbursement, facilitating wider access across the diabetes population.

I have no disclosures.

Citation:

Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes

Julia Ware, M.D., Janet M. Allen, R.N., Charlotte K. Boughton, Ph.D., Malgorzata E. Wilinska, Ph.D., Sara Hartnell, B.Sc., Ajay Thankamony, M.Phil., Carine de Beaufort, Ph.D., Ulrike Schierloh, M.D., Elke Fröhlich-Reiterer, M.D., Julia K. Mader, M.D., Thomas M. Kapellen, Ph.D., Birgit Rami-Merhar, M.D.,  for the KidsAP Consortium
January 20, 2022
N Engl J Med 2022; 386:209-219
DOI: 10.1056/NEJMoa2111673

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Jan 20, 2022 @ 5:07 pm

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