The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omnipod 5, Multiple daily injections of insulin.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 7 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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).
Interventions
- 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 - Drug Multiple daily injections of insulin
Multiple daily infections of insulin to treat type 1 diabetes
Primary outcome measures
- Time in Range [Time frame: During the first 2 years]
Secondary outcome measures (8)
- TINR [Time frame: During the first 2 years]
- Complications [Time frame: 15 years]
- HbA1c [Time frame: 2 years]
- Mean sensor glucose value [Time frame: 2 years]
- Glycemic variability [Time frame: 2 years]
- Continuous Ketone monitoring (CKM) [Time frame: During the first 2 years]
- Cost-effectiveness [Time frame: 15 years]
- Custom food list [Time frame: During the first 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 2 centers
- Jorvi Hospital — Espoo
- New Children's Hospital — Helsinki
Identifiers
NCT: NCT07423637 · HelDiabKids_AID