Early automated insulin delivery in children with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the use of an automated insulin delivery (AID) system (OmniPod 5) versus multiple daily injections with continuous glucose monitoring in newly diagnosed pediatric patients. It aims to assess glycemic control, diabetes distress in patients and caregivers, long-term vascular complications, and cost-effectiveness. The setting is in Finland at Helsinki University Central Hospital and participating centers, with collaboration from Insulet, Abbott Diabetes Care, and NordicInfu Care. Enrollment targets children diagnosed within the past month at the participating pediatric units. The trial will compare clinical outcomes and economic considerations of early AID initiation against conventional therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jorvi Hospital
  Espoo, Finland Recruiting
• New Children's Hospital
  Helsinki, Finland Recruiting

Study contacts

• Principal investigator: Tero Varimo, MD, PhD — Helsinki University Central Hospital
• Study coordinator: Anna-Kaisa Tuomaala, MD, PhD
• Email: anna-kaisa.tuomaala@hus.fi
• Phone: +358505430180

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity

  This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.

  Recruiting Phase 2/3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07891156

• Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes

  This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.

  Recruiting at 11 sites Medtronic MiniMed, Inc. · Chula Vista, California and 17 other locations · NCT07864168

• CGM-guided carb awareness education for adults with Type 1 diabetes

  This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07807280

• Safety and effectiveness of GLP-1 receptor agonists and SGLT inhibitors added to insulin in adults with type 1 diabetes

  This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.

  Recruiting at 17 sites Indiana University · Newport Beach, California and 16 other locations · NCT07676565

• Think-Find-Solve activities for insulin self-management in children with type 1 diabetes

  A behavior-change activity book is tested with children aged 8–12 with type 1 diabetes and their parents to see if it improves daily insulin self-management.

  Recruiting Marmara University · Istanbul · NCT07670572

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.