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ClinicalTrials.gov ID

NCT07423637

Lead Sponsor

Helsinki University Central HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Mar 17, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

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

Brief 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).

• Type 1 Diabetes

• Omnipod 5
• Multiple daily injections of insulin

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Insulet CorporationINDUSTRY

Abbott Diabetes CareINDUSTRY

NordicInfu Care ABINDUSTRY

anna-kaisa.tuomaala@hus.fi+358505430180