The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment

NCT07423637 — Not applicable, Recruiting, 100 participants, Helsinki University Central Hospital

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The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment - a Prospective, Randomized, Controlled Study on Pediatric Patients With Type 1 Diabetes

Registry	NCT07423637
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Helsinki University Central Hospital (Other); collaborators: Insulet Corporation, Abbott Diabetes Care, NordicInfu Care AB
Conditions	Type 1 Diabetes
Interventions	Omnipod 5, Multiple daily injections of insulin (Device, drug)
Dates	start 2026-08-15, primary completion 2027-12-30 (estimated), completion 2028-12-31 (estimated), first posted 2026-02-20, last updated 2026-10-14
Locations	2 sites in Finland

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
Early AID-treatment	Experimental	Device: Omnipod 5	Automated insulin delivery system (Omnipod 5) is initiated after T1D diagnosis. Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries. Continious glucose monitoring (CGM) is used.
Control group	Active comparator	Drug: Multiple daily injections of insulin	Multiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used.

Omnipod 5 (Device): 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 injections of insulin (Drug): Multiple daily infections of insulin to treat type 1 diabetes

+Outcome measures

Primary outcomes

Time in Range [During the first 2 years]: 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).

Secondary outcomes

TINR [During the first 2 years]: Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data
Complications [15 years]: The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease
HbA1c [2 years]: The change in HbA1c levels (mmol/mol) during the treatment between the groups
Mean sensor glucose value [2 years]: The change in mean sensor glucose value (mmol/l) obtained from continuous glucose monitoring between the groups during treatment
Glycemic variability [2 years]: 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
Continuous Ketone monitoring (CKM) [During the first 2 years]: Continous Ketone monitoring with a CKM sensor will be performed at 2 time points during the follow-up period
Cost-effectiveness [15 years]: The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling
Custom food list [During the first 2 years]: 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.

+Eligibility

Sex: All, ages: 7 Years to 16 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* Addison's disease
* Renal failure
* Untreated coeliac disease
* Untreated thyroid disorder
* Poorly controlled asthma, per investigator judgment.
* Unresolved adverse skin conditions in the area of sensor placement (e.g. pso-riasis, rash, Staphylococcus infection).
* Participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.

+Locations (2)

Facility	City	Country	Status
Jorvi Hospital	Espoo	Finland	Recruiting
New Children's Hospital	Helsinki	Finland	Recruiting

+Investigators

Anna-Kaisa Tuomaala, MD, PhD, Study director, Helsinki University Central Hospital
Tero Varimo, MD, PhD, Principal investigator, Helsinki University Central Hospital
Mari-Anne Pulkkinen, MD, PhD, Study chair, Helsinki University Central Hospital