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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Omnipod 5; Drug: Multiple daily injections of insulin

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna-Kaisa Tuomaala, MD, PhD; Phone Number: +358505430180; Email: anna-kaisa.tuomaala@hus.fi
• Study Contact Backup: Name: Tero Varimo, MD, PhD; Phone Number: +358445573392; Email: tero.varimo@hus.fi

Study Locations

• Finland
  • Espoo, Finland, 02740
    • Jorvi Hospital
    • Contact: Anna-Kaisa Tuomaala, MD, PhD; Phone Number: +358505430180; Email: anna-kaisa.tuomaala@hus.fi
    • Sub-Investigator: Tero Varimo, MD, PhD
    • Contact: Mari-Anne Pulkkinen, MD,PhD; Phone Number: +358094711; Email: mari-anne.pulkkinen@hus.fi
    • Principal Investigator: Mari-Anne Pulkkinen, MD, PhD
    • Sub-Investigator: Anna-Kaisa Tuomaala, MD, PhD
    • Sub-Investigator: Panu Oksanen, MD, PhD
    • Sub-Investigator: Heidi Falk, MD
  • Helsinki, Finland, 00029
    • New Children's Hospital
    • Contact: Anna-Kaisa Tuomaala, MD, PhD; Phone Number: +358505430180; Email: anna-kaisa.tuomaala@hus.fi
    • Contact: Tero Varimo, MD, PhD; Phone Number: +358445573392; Email: tero.varimo@hus.fi
    • Sub-Investigator: Heidi Falk, MD
    • Sub-Investigator: Tero Varimo, MD,PhD
    • Principal Investigator: Anne-Kaisa Tuomaala, MD,PhD
    • Sub-Investigator: Mari-Anne Pulkkinen, MD, PhD
    • Sub-Investigator: Panu Oksanen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early AID-treatment; 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; Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries
Active Comparator: Control group; 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; Multiple daily infections of insulin to treat type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Insulet Corporation; Abbott Diabetes Care; NordicInfu Care AB
• Investigators: Study Director: Anna-Kaisa Tuomaala, MD, PhD, Helsinki University Central Hospital; Principal Investigator: Tero Varimo, MD, PhD, Helsinki University Central Hospital; Study Chair: Mari-Anne Pulkkinen, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: type 1 diabetes; Automated insulin delivery system
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HelDiabKids_AID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be made publicly available. De-identified data may be shared upon reasonable request to the principal investigator, subject to applicable EU and Finnish data protection legislation and institutional approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No