The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs

The Impact of Hybrid Closed-loop Insulin Delivery (Medtronic MiniMed 670G and 780G System, Tandem t:Slim X2 Control-IQ, and Omnipod 5) on Glycemic Control and Patient-reported Outcomes in People Living With Type 1 Diabetes: a Multicenter Real-world Observational Study and Safety Study in Young Children (2-6 Years Old) in Belgium

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these automated insulin delivery systems on glycemic management and patient-reported outcomes (PROMs) under real-world conditions is still unclear. Therefore, this prospective, multicenter real-world observational study will evaluate the real-world impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G, Tandem Control-IQ and Omnipod 5 systems, separately, on glycemic management and PROMs in people living with type 1 diabetes and to evaluate the safety of the Medtronic MiniMed 780G in young children with type 1 diabetes (2-6 years old). Participants will be followed in routine clinical practice for a period of 24 months after initiation of the system. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of hybrid closed-loop therapy.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.

People with type 1 diabetes, aged 7 years and older who start with the Medtronic MiniMed 670G or 780G system, aged 6 years and older who start with the Tandem t:slim X2 Control-IQ or those aged 2 years and older who start with the Omnipod 5 in the participating centers and who signed informed consent or gave informed assent (pediatrics) are eligible to participate. For the safety study, children with type 1 diabetes aged 2-6 years old who start(ed) with the Medtronic MiniMed 780G system in Manual Mode, whose parents agree to enable Auto Mode (after at least 4 weeks of Manual Mode) and whose parents signed informed consent can be included. Auto Mode enablement is only possible if time since type 1 diabetes diagnosis is at least 6 months.

The decision about which person with type 1 diabetes to start, is left to the clinical judgement of the treating health care professional.