Type 1 DiabetesNCT07423637
The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment
A study testing Omnipod 5 and Multiple daily injections of insulin in people with Type 1 Diabetes, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Omnipod 5 and Multiple daily injections of insulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 15 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Jorvi Hospital
Espoo, 02740
Anna-Kaisa Tuomaala, MD, PhD, +358505430180, anna-kaisa.tuomaala@hus.fi
Mari-Anne Pulkkinen, MD,PhD, +358094711, mari-anne.pulkkinen@hus.fi
- Recruiting
New Children's Hospital
Helsinki, 00029
Anna-Kaisa Tuomaala, MD, PhD, +358505430180, anna-kaisa.tuomaala@hus.fi
Tero Varimo, MD, PhD, +358445573392, tero.varimo@hus.fi
About this study
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
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).
- Conditions
- Type 1 Diabetes
- Being tested
- Omnipod 5, Multiple daily injections of insulin
- Keywords
- type 1 diabetes, Automated insulin delivery system
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5Device
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 insulinDrug
Multiple daily infections of insulin to treat type 1 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Early AID-treatment | Experimental | 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. Receives: Device: Omnipod 5 |
| Control group | Active comparator | Multiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used. Receives: Drug: Multiple daily injections of insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the first 2 years
Secondary outcomes (8)
TINR
Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data
Measured: During the first 2 years
Complications
The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease
Measured: 15 years
HbA1c
The change in HbA1c levels (mmol/mol) during the treatment between the groups
Measured: 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
Measured: 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
Measured: 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
Measured: During the first 2 years
Cost-effectiveness
The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling
Measured: 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.
Measured: During the first 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Aug 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Insulet Corporation, Abbott Diabetes Care, NordicInfu Care AB
- Responsible party
- Principal investigator, Tero Varimo, MD, PhD, Helsinki University Central Hospital
- Investigators
- Anna-Kaisa Tuomaala, MD, PhD, Study director, Helsinki University Central HospitalTero Varimo, MD, PhD, Principal investigator, Helsinki University Central HospitalMari-Anne Pulkkinen, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423637
- Sponsor's protocol ID
- HelDiabKids_AID
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07423637
- Acronym / sponsor ID
- HelDiabKids_AID
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, Automated insulin delivery system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Insulet Corporation, Abbott Diabetes Care, NordicInfu Care AB
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early AID-treatment | Experimental | Device: Omnipod 5Automated 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. |
| Control group | Active comparator | Drug: Multiple daily injections of insulinMultiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Addison's disease
- Renal failure
- Untreated coeliac disease
- Untreated thyroid disorder
- Poorly controlled asthma, per investigator judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod 5Omnipod5 uses a SmartAdjust™ closed-loop algorithm to automate insulin delivery. Algorithm continuously predicts glucose trends and self-adjusts insulin delivery within safety boundaries | Device | Early AID-treatment |
| Multiple daily injections of insulinMultiple daily infections of insulin to treat type 1 diabetes | Drug | Control group |
Primary outcome
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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna-Kaisa Tuomaala, MD, PhD study director
Helsinki University Central Hospital
Tero Varimo, MD, PhD principal investigator
Helsinki University Central Hospital
Mari-Anne Pulkkinen, MD, PhD study chair
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipod 5 and Multiple daily injections of insulin in people with Type 1 Diabetes, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna-Kaisa Tuomaala, MD, PhD (+358505430180, anna-kaisa.tuomaala@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: During the first 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.