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

NCT07423637 | Not Yet Recruiting DMC

• 1 other identifier: HelDiabKids_AID
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Automated insulin delivery system

Outcome Measures

Primary Outcomes (1)

• 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).

  During the first 2 years

Secondary Outcomes (8)

• TINR

  During the first 2 years

• Complications

  15 years

• HbA1c

  2 years

• Mean sensor glucose value

  2 years

• Glycemic variability

  2 years

Study Arms (2)

Early AID-treatment

EXPERIMENTAL

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.

Device: Omnipod 5

Control group

ACTIVE COMPARATOR

Multiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used.

Drug: Multiple daily injections of insulin

Interventions

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

Early AID-treatment

Multiple daily injections of insulin DRUG

Multiple daily infections of insulin to treat type 1 diabetes

Control group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Insulet Corporation: collaborator
• Abbott Diabetes Care: collaborator
• NordicInfu Care AB: collaborator

Study Sites (2)

Jorvi Hospital

Espoo, 02740, Finland

Location

New Children's Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anna-Kaisa Tuomaala, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

• Tero Varimo, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Mari-Anne Pulkkinen, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

Central Study Contacts

Anna-Kaisa Tuomaala, MD, PhD

CONTACT

+358505430180; anna-kaisa.tuomaala@hus.fi

Tero Varimo, MD, PhD

CONTACT

+358445573392; tero.varimo@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, pediatric endocrinologist

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

FI (2)