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

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).

Conditions

• Type 1 Diabetes

Interventions

DEVICE

Omnipod 5

Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries

DRUG

Multiple daily injections of insulin

Multiple daily infections of insulin to treat type 1 diabetes

Sponsors & Collaborators

• Insulet Corporation

  collaborator INDUSTRY

• Abbott Diabetes Care

  collaborator INDUSTRY

• NordicInfu Care AB

  collaborator INDUSTRY

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Anna-Kaisa Tuomaala, MD, PhD · Helsinki University Central Hospital

• Tero Varimo, MD, PhD · Helsinki University Central Hospital

• Mari-Anne Pulkkinen, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2027-09-30

Completion

2028-12-31

Countries

• Finland

Study Locations