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 and DKA. Further impact e. g. mean insulin dose, long-term efficacy, consumed fat/protein in the daily diets, etc., remains to be studied in future larger and longer studies.
NCT01464346, Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150019
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