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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Omnipod5 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 infections of insulin to treat type 1 diabetes
Jorvi Hospital
Espoo, Finland
New Children's Hospital
Helsinki, Finland
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).
Time frame: During the first 2 years
TINR
Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data
Time frame: During the first 2 years
Complications
The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease
Time frame: 15 years
HbA1c
The change in HbA1c levels (mmol/mol) during the treatment between the groups
Time frame: 2 years
Mean sensor glucose value
The change in mean sensor glucose value (mmol/l) obtained from continuous glucose monitoring between the groups during treatment
Time frame: 2 years
Glycemic variability
The change in glycemic variability (coefficient of variation CV (SD/mean sensor glucose x 100%)) obtained from continuous glucose monitoring data between the groups during treatment
Time frame: 2 years
Continuous Ketone monitoring (CKM)
Continous Ketone monitoring with a CKM sensor will be performed at 2 time points during the follow-up period
Time frame: During the first 2 years
Cost-effectiveness
The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling
Time frame: 15 years
Custom food list
The Custom Food List is a personalized menu integrated into the AID pump. Patients can select a predefined meal from the list before eating, without calculating the carbohydrate content, and the pump automatically delivers the preset insulin dose assigned to that item. We evaluated the impact of using the Custom Food List on Time in range (TIR, %), Time in Normoglycemic Range (TINR, %), Time below Range (TBR, %), and postprandial glucose levels compared with conventional carbohydrate counting.
Time frame: During the first 2 years
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