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NCT Number: NCT07423637

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

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jorvi Hospital, Espoo, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Multiple daily injections of insulin

Drug

Multiple daily infections of insulin to treat type 1 diabetes

Primary outcomes

  1. Time in Range

    Time frame: During the first 2 years

    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).

Secondary outcomes

  1. TINR

    Time frame: During the first 2 years

    Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data

  2. Complications

    Time frame: 15 years

    The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease

  3. HbA1c

    Time frame: 2 years

    The change in HbA1c levels (mmol/mol) during the treatment between the groups

  4. Mean sensor glucose value

    Time frame: 2 years

    The change in mean sensor glucose value (mmol/l) obtained from continuous glucose monitoring between the groups during treatment

  5. Glycemic variability

    Time frame: 2 years

    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

  6. Continuous Ketone monitoring (CKM)

    Time frame: During the first 2 years

    Continous Ketone monitoring with a CKM sensor will be performed at 2 time points during the follow-up period

  7. Cost-effectiveness

    Time frame: 15 years

    The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling

  8. Custom food list

    Time frame: During the first 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Kaisa Tuomaala, MD, PhD

CONTACT

[email protected]

+358505430180

Tero Varimo, MD, PhD

CONTACT

[email protected]

+358445573392

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Abbott Diabetes Care
  • Insulet Corporation
  • NordicInfu Care AB

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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