Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, Automated insulin delivery system
Brief 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 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
DEVICEOmnipod 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
Multiple daily infections of insulin to treat type 1 diabetes
Sponsors
Helsinki University Central Hospital
Insulet Corporation
Abbott Diabetes Care
NordicInfu Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TINR | During the first 2 years | Time spent (%) in normoglycemic range (TINR, 3.9-7.8 mmol/l) based on continuous glucose monitorin (CGM) data |
| Complications | 15 years | The development of diabetes-related complications such as diabetic nephropathy, diabetic retinopathy, neuropathy, coronary artery disease |
| HbA1c | 2 years | The change in HbA1c levels (mmol/mol) during the treatment between the groups |
| Mean sensor glucose value | 2 years | The change in mean sensor glucose value (mmol/l) obtained from continuous glucose monitoring between the groups during treatment |
| Glycemic variability | 2 years | 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 |
| Continuous Ketone monitoring (CKM) | During the first 2 years | Continous Ketone monitoring with a CKM sensor will be performed at 2 time points during the follow-up period |
| Cost-effectiveness | 15 years | The cost-effectiveness of different treatment modalities for T1D in children with Cost-Utility Analysis modeling |
| Custom food list | During the first 2 years | 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. |
Countries
Finland
Contacts
CONTACTAnna-Kaisa Tuomaala, MD, PhD
CONTACTTero Varimo, MD, PhD
STUDY_DIRECTORAnna-Kaisa Tuomaala, MD, PhD
Helsinki University Central Hospital
PRINCIPAL_INVESTIGATORTero Varimo, MD, PhD
Helsinki University Central Hospital
STUDY_CHAIRMari-Anne Pulkkinen, MD, PhD
Helsinki University Central Hospital
Outcome results
None listed