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Case Example. Tailored Data Study

Based on >600,000 patient-years from Swedish national registry data.

Real-world evidence study of automated insulin delivery in Sweden

How Swedish registry data was used to demonstrate superior effect of automated insulin delivery against standard therapy and associated differences in HbA1c reduction between competing systems.
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Context

The introduction of automated insulin delivery (AID) systems represents a major shift in the management of type 1 diabetes. At the same time, these technologies are subject to increasing scrutiny from payers and health technology assessment (HTA) bodies.

In Sweden, national authorities have recently undertaken a large-scale evaluation of AID systems to support reimbursement and implementation decisions. This included a health economic assessment commissioned by the Medical Technology Product Council (MTP-rådet) and conducted by the Dental and pharmaceutical benefits agency (TLV).

While this evaluation concluded that AID systems are cost-effective in comparison to the reference therapy (pen-based injection with continuous glucose monitoring, MDI with CGM), the analysis was conducted without differentiating between the AID systems. Furthermore, uncertainty in the results were partly attributed to lack of long-term data on the treatment effects.  

Objective

To evaluate real-world glycemic outcomes associated with different insulin delivery and glucose monitoring technologies in adults with type 1 diabetes in Sweden.

A particular focus was placed on automated insulin delivery (AID) systems, including assessing differences in outcomes between available technologies.

The aim was to generate comparative, population-level evidence to support understanding of relative effectiveness in routine clinical practice and inform payer and HTA decision-making.

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Data & Methodology

The study was based on data from the Swedish National Diabetes Register, covering more than 95% of individuals with type 1 diabetes in Sweden

A retrospective, registry-based cohort design was applied, including over 600,000 patient-years between 2014 and 2024.

Analyses were conducted using mixed-effects regression, adjusting for key patient and clinical factors, including age, disease duration, BMI, lifestyle factors, and clinic variation.

Outcomes were assessed using HbA1c, a clinically established and payer-relevant endpoint.

 

Key Findings

4.0 mmol/mol

HbA1c Reduction

Average improvement in AID use versus MDI+CGM.

4.8 mmol/mol

Greatest Improvement

The largest effect was seen for patients using the Tandem Control-IQ system.

1.8 mmol/mol

Difference between systems

The difference in HbA1c reduction between the two main competing AID systems was significant and substantial.

0.5 mmol/mol

Yearly improvement

Over the 10-year period, almost all treatment groups saw an gradual improvement.

55%

Pump users with AID

Over the time period a shift towards pump use and to more advanced pump systems was observed.

Interpretation

The analysis demonstrates that advanced insulin delivery technologies deliver clinically meaningful improvements in real-world settings.

Importantly, the magnitude of HbA1c reduction is sufficient to impact long-term complication risk and is directly relevant for health economic modelling and payer evaluation.

Finally, the results show that there are significant differences in treatment outcome between different AID systems in real-world settings.

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Impact

This study provides robust, large-scale real-world evidence supporting the adoption of automated insulin delivery systems in routine care.

The findings:

  • Reinforce evidence from clinical trials
  • Provide population-level validation in a national healthcare setting
  • Support reimbursement discussions and value communication

Client perspective

“Agnostic Technology helped us generate robust, large-scale real-world evidence demonstrating the clinical value of automated insulin delivery in routine care.

The analysis strengthened both our competitive positioning and our case for reimbursement by delivering outcomes directly relevant for HTA and payer discussions.

The team combined strong methodological expertise with clear strategic insight and took the project from inception to a high-quality publication.

We highly recommend them.”

Charlotte Ekelund, MD, PhDCharlotte Ekelund, MD, PhDMedical Liaison Manager, Rubin Medical AB
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Publication

Ståhl F, Hellman J, Ekelund C. Automated Insulin Delivery Associated with Superior Glycemic Outcomes in Type 1 Diabetes: A Swedish National Registry Analysis. Diabetes Technology & Therapeutics. 2026;0(0). doi:10.1177/15209156251414976

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