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Early automated insulin delivery compared with insulin injections in children with type 1 diabetes

Compares the Omnipod 5 pump with daily insulin injections in children with type 1 diabetes.

Plain-language title generated from the registry record
Registry title: The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment

Key facts

Where
Espoo and Helsinki, FinlandSee the 2 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 7 and 16 years old?

Source: NCT07423637, who can take part

Where in Finland

  • Jorvi HospitalEspoo, FinlandTaking people
  • New Children's HospitalHelsinki, FinlandTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Helsinki University Central Hospital
Trial code
NCT07423637
Record updated
14 October 2026
Original description
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.Read full original descriptionShow less

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

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).

Inclusion: 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: 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; Addison's disease; Renal failure; Untreated coeliac disease; Untreated thyroid disorder; Unresolved adverse skin conditions in the area of sensor placement (e.g. pso-riasis, rash, Staphylococcus infection); Poorly controlled asthma, per investigator judgment.

ClinicalTrials.gov NCT07423637