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| Name | Class |
|---|---|
| Insulet Corporation | INDUSTRY |
| Abbott Diabetes Care | INDUSTRY |
| NordicInfu Care AB | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | Multiple daily insulin injections (MDI) is initiated after T1D with a standard treatment protocol. Continious glucose monitoring (CGM) is used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During the first 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| TINR | Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data | During the first 2 years |
| Complications | The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna-Kaisa Tuomaala, MD, PhD | Contact | +358505430180 | anna-kaisa.tuomaala@hus.fi | |
| Tero Varimo, MD, PhD | Contact | +358445573392 | tero.varimo@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Anna-Kaisa Tuomaala, MD, PhD | Helsinki University Central Hospital | Study Director |
| Tero Varimo, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorvi Hospital | Espoo | 02740 | Finland |
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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| Multiple daily injections of insulin | Drug | Multiple daily infections of insulin to treat type 1 diabetes |
|
| 15 years |
| HbA1c | The change in HbA1c levels (mmol/mol) during the treatment between the groups | 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 | 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 | 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 | During the first 2 years |
| Cost-effectiveness | The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling | 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. | During the first 2 years |
| Mari-Anne Pulkkinen, MD, PhD |
| Helsinki University Central Hospital |
| Study Chair |
| New Children's Hospital | Helsinki | 00029 | Finland |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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