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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2027 → Dec 30, 2027
See other at-risk trials from Helsinki University Central Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Apr 1, 2026 to Aug 15, 2026
    • Primary completion pushed from Sep 30, 2027 to Dec 30, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Site details revised at 2 of 2 sites
  2. Secondary endpoints: 7 to 8v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07423637
Lead Sponsor Helsinki University Central Hospital
Collaborators: Insulet Corporation, Abbott Diabetes Care, NordicInfu Care AB
Conditions
(from sponsor)		 Type 1 Diabetes
Related terms Diabetes Mellitus, Type 1
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov