Advantages from “do-it-yourself” loops among children and adolescents in Varna’s Diabetes Center

Abstract

INTRODUCTION: In the last 5 years, the use of automatic insulin delivery systems has been increasing among patients with type 1 diabetes mellitus (T1DM). It has been shown that they improve metabolic control, decrease the time spent in hypoglycemia and the number of episodes of nocturnal hypoglycemia; increase the time spent in target and are feasible and safe. AIM: Our aim is to evaluate the glycemic control in children/adolescents using do-it-yourself (DIY) regulatory unapproved insulin-delivery loops vs sensor-augmented pump therapy (SAP). MATERIALS AND METHODS: A total of 43 families with child/children with T1DM on pump treatment and continuous use of continuous glucose monitoring (CGM) were invited to participate in the study; 31 (72.1%) of the families accepted. The children were followed for 6 months, a total of 196 patient months. RESULTS:The study group consisted of 31 children with T1DM, 24 (77.4%) of them were on SAP, and 7 (22.6%) used DIY loops. No differences were observed in regard to age, duration of diabetes, and daily insulin dose between groups. Patients on DIY loops spent significantly more time in range (83.0 vs 68.8%, p=0.02), less time in hyperglycemia above 14 mmol/L (2.1 vs 8.6%, p=0.02). They had significantly better HbA1c at the 6th month (6.5 vs 7.2%, p=0.006) vs SAP patients for the follow-up period. No severe hypoglycemia and diabetic ketoacidosis (DKA) occurred. There were no gender differences between and within both groups. CONCLUSION: DIY unregistered loop systems showed promising results for better metabolic control at least in terms of mean blood glucose levels (BGLs) and without increasing the risk of severe hypoglycemia

User‐driven, open‐source diabetes technology (special issue): Paediatric DIY APS

“…Similar results were found by Petruzelkova et al reported that DIY APS among children with type 1 diabetes (age 6–15 years, n = 22) during a winter ski camp resulted in significant improvements in TIR without any hypoglycaemic episodes 7 . A further study from Bulgaria showed that the use of DIY APS loops significantly improved the TIR (83% vs. 68.8%) and HbA1c (6.5% vs. 7.2%) in 31 children with type 1 diabetes 8 …”

“…7 A further study from Bulgaria showed that the use of DIY APS loops significantly improved the TIR (83% vs. 68.8%) and HbA1c (6.5% vs. 7.2%) in 31 children with type 1 diabetes. 8 In paediatric diabetes, healthcare professionals looking after children have expressed concern that regulatory or legal actions could ensue through advising people on diabetes management based on data obtained from DIY APS closedloop systems due to lack of safety data, funding or insurance coverage, ethical and consent processes as parents and carers make the decision to use DIY APS on behalf of the child. 9 Prior to 2020, in the United Kingdom, regulated hybrid loop systems were not available and DIY APS was the only source that could enable this technology to improve type1 diabetes management.…”