The purpose of this study is to investigate the effect of early initiated automated insulin de-livery (AID) treatment in type diabetes in children aged 7-16 years to glycemic control, diabe-tes distress of patients and caregivers, long-term micro- and macrovascular complications and cost-effectiveness compared to multiple daily injections (MDI) and continuous glucose monitoring (CGM). The immediate costs of AID therapy are higher than costs of multiple daily injection therapy, and there has been debate whether the more expensive AID therapy is justified. No research on the cost-effectiveness of AID use in children has been conducted so far in Finland, and there is generally very little research data on the long-term treatment of type 1 diabetes with AID systems. AID therapy has been studied from the point of diagno-sis of type 1 diabetes in two centers (USA and the UK) but from the perspective of maintain-ing subject's own insulin secretion. A long-term randomized and controlled study on the out-comes and cost-effectiveness of AID therapy, started from diagnosis of diabetes, is essential to create evidence-based data for optimizing current treatment recommendations.
Our hypothesis is that AID treatment keeps the glycemic outcomes in targets in the long term and decreases diabetes distress. During longer time, AID system decreases the amount of micro- and macrovascular complications and is cost-effective treatment for children with type 1 diabetes (CwT1D).
Children and adolescents aged 7-15 years who are re-cently (within a month) diagnosed with type 1 diabetes at the Children's and Adolescents' Unit of HUH at the New Children's Hospital and Jorvi Hospital
Addison's disease
Renal failure
Untreated coeliac disease
Untreated thyroid disorder
Parallel
Omnipod 5
DeviceOmnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries
Multiple daily injections of insulin
DrugMultiple daily infections of insulin to treat type 1 diabetes
Time in Range
Percentage (%) of the time patients' glucose levels are within the target range based on continuous glucose monitoring (time in range =TIR, 3.9-10 mmol/l).
TINR
Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data
Complications
The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease
HbA1c
The change in HbA1c levels (mmol/mol) during the treatment between the groups
Mean sensor glucose value
The change in mean sensor glucose value (mmol/l) obtained from continuous glucose monitoring between the groups during treatment
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Helsinki University Central Hospital
Lead sponsor
Insulet Corporation
Collaborator
Abbott Diabetes Care
Collaborator
NordicInfu Care AB
Collaborator
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