To Örebro University

AIMS: Automated insulin delivery (AID) is part of the standard of care for type 1 diabetes (T1D), but real-world evidence (RWE) comparing AID systems remains limited. A systematic review and meta-analysis was conducted for outcomes across commercially available AID systems in real-world settings.

MATERIALS AND METHODS: PubMed and Embase were searched to March 2025 for RWE studies of commercial AID systems in ambulatory people with T1D. Eligible studies had n ≥ 250 with ≥10 days of continuous glucose monitoring data. Main outcomes were time in range (TIR) and glycated haemoglobin (HbA1c). Random-effects meta-analyses with AID system as moderator were performed, including scenario analyses by age and optimal device settings.

RESULTS: Thirty-six records covering 34 studies with 635 463 users were included. Studies evaluated MiniMed™ 780G (n = 16), Control-IQ™ (n = 9), MiniMed™ 670G (n = 6), and other systems (≤3 studies each). Meta-analysis demonstrated frequently statistically significant between-system differences in TIR, ranging from 60.1% (95% confidence interval [CI] 54.0 to 65.9) for Omnipod® 5 to 73.9% (95% CI 72.3 to 75.5) for MiniMed 780G. For HbA1c, estimates ranged from 6.5% (95% CI 5.4 to 7.7) for Loop to 7.0% (95% CI 6.7 to 7.4) for MiniMed 780G, although differences were not significant. Significant residual heterogeneity was observed. Age was an important effect modifier, with younger users experiencing less favourable outcomes. Optimal device settings improved glycaemic outcomes.

CONCLUSIONS: RWE demonstrated differences in glycaemic outcomes, including TIR, between commercially available AID systems. User age influenced outcomes for all systems. Results must be interpreted cautiously given challenges and potential biases with RWE.

Background and Aims: Clinical evidence demonstrates FreeStyle Libre systems (FSL) is associated with reduced healthcare resource utilization (HCRU) for all insulin-treated individuals living with diabetes. However, reimbursement of FSL in most European countries remains restricted to people with type 1 diabetes (T1D) and type 2 diabetes (T2D) on intensively managed insulin regimens. This study estimated the budget impact of expanding FSL access to people with T2D on basal insulin only (T2B) from a European payer perspective.

Methods: A 1-year budget impact analysis was developed for a hypothetical T2B cohort of 1,000 individuals. This analysis included acquisition costs of FSL, blood glucose monitoring supplies, and hospital costs. Clinical inputs were derived from a Swedish real-world study, FSL vs SMBG, which reported a 24% reduction in annual all-cause hospitalization events for the T2B population. HCRU costs were based on published studies across Europe, inflated to 2024 euros. One-way sensitivity analysis (OWSA) was conducted to identify key model drivers.

Results: Expanding reimbursement of FSL to the T2B population resulted in a net cost savings of €184 per patient per year. At a cohort level, this translated to a net annual cost savings of €183,980 for the payer. OWSA identified the baseline rate of hospitalization and cost of all-cause healthcare resource utilization as key model drivers.

Conclusions: This budget impact analysis showed the acquisition cost of FSL is offset by HCRU reduction in the T2B population. As such, reimbursement expansion of FSL in this population can result in significant net cost savings to European health systems.

Continuous glucose monitoring (CGM) systems are essential tools for modern diabetes care. However, the assessment of their analytical performance has been hindered by a lack of standardization. This poses challenges for the field, as the choice of study procedures and evaluation methods can influence the observed performance, further complicating the comparisons between CGM systems and confounding the interpretation and use of CGM metrics as research outcomes. To address this issue, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed a comprehensive guideline for the clinical assessment of CGM systems. The guideline defines requirements for study design and procedures, characteristics of comparator measurements, minimum requirements for accuracy, and performance characterization.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is one of the most common chronic diseases in Sweden. Continuous glucose monitoring (CGM) is an increasingly important alternative to self-monitoring of blood glucose (SMBG), particularly for people receiving insulin.

OBJECTIVES: To summarize the evidence for CGM in insulin-treated T2DM and conduct a policy landscape analysis of national and local guidelines to explore access to CGM in Sweden relative to other countries.

METHODS: A scoping review was conducted to identify evidence on the clinical, patient, and economic value of CGM, supplemented with searches of Swedish and European guidelines. Current recommendations for CGM in T2DM in Sweden were compared with European-wide and country-specific recommendations. Regional recommendations and funding processes within Sweden were reviewed to examine heterogeneity in local access to CGM.

RESULTS: Across international and Swedish studies, CGM was associated with improved clinical outcomes compared with SMBG, both for people with intensive insulin-treated T2DM and those on basal insulin only. The clinical benefits likely translate into fewer long-term diabetes complications and reduced resource utilization and budget impact versus SMBG. Health economic evaluations show that CGM can be considered a cost-effective intervention for all individuals treated with insulin in Sweden. European-wide guidance supports consideration of CGM for all insulin-treated individuals, but access in Sweden remains limited outside of the high-risk intensive insulin-treated population. This is exacerbated by regional heterogeneity in access, which partly stems from the attribution of budget responsibility to individual primary care units.

CONCLUSIONS: The benefits associated with CGM show that an expansion of the Swedish recommendations to cover all insulin-treated people with T2DM is warranted. Persistent regional disparities must be addressed to ensure equitable access to care for people with T2DM in Sweden. The establishment of dedicated funding mechanisms within primary care should be considered to promote more equitable and sustainable access.

AIMS: This study evaluated long-term cost-effectiveness of automated insulin delivery (AID) systems versus multiple daily injections (MDI) + CGM in children with type 1 diabetes (T1D), adults with T1D and insulin-treated individuals with type 2 diabetes (T2D) across Denmark, Finland, Norway and Sweden.

MATERIALS AND METHODS: Clinical outcomes and economic footprints were analysed for horizons up to 50 years from a healthcare system perspective using the IQVIA Core Diabetes Model. Five patient profiles were modelled: T1D paediatrics (T1D-Paed), T1D adults with high baseline HbA1c (T1D-Adult), real-world evidence in T1D adults with lower baseline HbA1c (T1D-AdultRWE), T2D adults (T2D-Adult) and older T2D adults (T2D-Elder). Costs were inflated to July 2024, with 3% annual discounting. Sensitivity analyses explored scenarios varying time horizons and HbA1c effect sizes and inclusion of hypoglycaemia rates.

RESULTS: AID systems were estimated to lead to a reduction in diabetes-related complications in all groups, most notably in the T1D-Adult group (318 vs. 542 complications per 100 individuals). Improvements translated into lifetime cost savings (€1435 to €26 259), increased life expectancy (LE) and more quality-adjusted life years (QALYs). Incremental cost-effectiveness ratios (ICERs) remained below willingness-to-pay thresholds in all countries (from €14 695/QALY for T1D-Adult in Finland to €56 711/QALY for T1D-AdultRWE in Denmark), confirming AID is cost-effective across all groups in the Nordic region.

CONCLUSIONS: AID therapy consistently projected reduced diabetes-related complications while remaining cost-effective across a broad spectrum of diabetes patient profiles in the Nordic region. These findings strengthen the case towards widespread integration of AID technology into national diabetes care frameworks.

AIMS: Type 1 diabetes (T1D) is an increasing clinical and economic concern in Sweden, as well as worldwide. Automated insulin delivery (AID) systems, combining continuous glucose monitoring (CGM) with automated insulin dosing to manage glucose levels, have been evaluated for the impact on glycaemic control and quality of life. This study examines the long-term cost-effectiveness of the AID system Control-IQ compared to standard care-defined as multiple daily injections or insulin pump therapy, both using CGM-in Swedish adults with T1D.

METHODS: A cost-utility analysis is performed using the IQVIA Core Diabetes Model, integrating clinical data from randomized trials and real-world sources. The model projects diabetes-related complications, direct medical costs and quality-adjusted life years (QALYs) over a lifetime period, applying Swedish-specific cost and discount rates.

RESULTS: Use of Control-IQ results in a gain of 1.080 QALYs and lower projected lifetime rates of severe hypoglycaemia, renal complications, cardiovascular events and ulcer/amputation/neuropathy. Total direct costs are higher, but the incremental cost-utility ratio is 391,705 SEK/QALY, which is below Sweden's commonly accepted threshold of 500,000 SEK/QALY. Sensitivity analyses demonstrate consistent results across different scenarios.

CONCLUSIONS: The results indicate that Control-IQ is a cost-effective alternative for Swedish adults with T1D and could be considered for broader use in diabetes care.

Several studies have demonstrated improvements in glucose control after initiation of automated insulin delivery (AID). This study aimed to evaluate glycemic outcomes and treatment-related barriers in subgroups of adults with type 1 diabetes (T1D) using AID systems in routine clinical practice. We analyzed data from 142 adults with T1D using Tandem Control IQ or MiniMed 780G. Correlation analyses were conducted to evaluate how changes in glycemic outcomes varied in relation to baseline characteristics. Mean age was 42 years, 40.8% were females, and median follow-up time was 1.7 years. Individuals with higher hemoglobin A1c (HbA1c) had less time below range (TBR) before starting AID (P < 0.001). Effects on glucose control were similar irrespective of sex, prior insulin therapy, body mass index, and diabetes duration, but varied in relation to glucose control. Following AID initiation, the estimated reduction in HbA1c was 1.3% (14.3 mmol/mol) in individuals with a baseline HbA1c of 8.6% (70 mmol/mol), compared to 0.3% (2.9 mmol/mol) in those with a baseline HbA1c of 6.7% (50 mmol/mol) (P < 0.001). Among individuals with a baseline TIR of 50% and 70%, the estimated increase in TIR following AID initiation was 19.0% and 7.2%, respectively (P < 0.001). Greater reductions in HbA1c were associated with smaller reductions in TBR and vice versa (r = - 0.29, P = 0.003). Among MiniMed 780G users, older age correlated with greater improvements in TIR (P = 0.005). Skin reactions tended to be more frequent in women (41%) than men (26%), P = 0.057. In conclusion, AID system use was associated with substantial reductions in HbA1c in individuals with poor glycemic control. Clinically meaningful reductions in HbA1c were achieved also in individuals with an HbA1c closer to target who additionally gained greater reductions in TBR.

BACKGROUND: Data regarding the impact of real-time continuous glucose monitoring (rt-CGM) on reducing adverse pregnancy outcomes in women with gestational diabetes are contradictory. We aimed to assess differences in the proportion of large-for-gestational-age (LGA) newborns between women using rt-CGM versus self-monitoring of blood glucose (SMBG).

METHODS: For this open-label, parallel-group, multicentre, randomised controlled trial, women aged 18-55 years with singleton pregnancy and gestational diabetes (diagnosed according to the International Association of the Diabetes and Pregnancy Study Groups criteria), were randomly assigned (1:1) to rt-CGM or SMBG. The first allocation was by chance; for subsequent allocations, minimisation was used to balance three prespecified factors: gestational age at study entry, previous gestational diabetes, and preconceptional BMI. SMBG participants used blinded CGM for 10 days after randomisation and at 36-38 weeks; rt-CGM participants used open rt-CGM until delivery. All were managed according to standard care protocols in four university hospitals in Austria, Germany, and Switzerland. The primary endpoint was the proportion of LGA newborns (using the Perinatal Institute's GROW customised birthweight percentiles), assessed in the intention-to-treat population. Secondary endpoints included the requirement for glucose-lowering medication, CGM metrics, and non-glycaemic maternal and neonatal outcomes. Recruitment and follow-up are complete. This study is registered with ClinicalTrials.gov (NCT03981328).

FINDINGS: Between Aug 24, 2020, and May 30, 2024, 610 women were screened for eligibility, of whom 375 (diagnosed with gestational diabetes at a mean of 25·2 weeks [SD 2·3] of gestation), were randomly assigned to rt-CGM (n=190) or SMBG (n=185) at a mean of 28·6 weeks (SD 1·9) of gestation. 170 intervention and 175 control participants with available data were assessed for the primary endpoint. LGA neonates were born to six (4%) of 170 rt-CGM and 18 (10%) of 175 SMBG participants (OR 0·32, 95% CI 0·10-0·87, p=0·014). Small-for-gestational-age (SGA) neonates were born to 33 (19%) and 23 (13%) participants, respectively (OR 1·59, 0·86-2·99, p=0·11). Serious adverse events occurred in 23 (12%) of 190 versus 28 (15%) of 185 participants (OR 0·77, 0·42-1·40, p=0·39).

INTERPRETATION: rt-CGM use in women with gestational diabetes reduced LGA births, without differences in serious adverse events. The higher-than-expected overall prevalence of SGA infants, possibly related to the tight glycaemic control in our cohort, requires further research.

TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Insulin has been used for over a century for the treatment of diabetes and, since the mid-1980s, there has been a rapid development of insulin administration tools. Over the last decade, several medical products used for diabetes management have been connected to a digital ecosystem. This connectivity includes sophisticated monitoring of not only glucose levels but also of insulin delivery (type, dose, time of dosing). It facilitates interactions between people with diabetes, various diabetes technology devices and healthcare professionals. This white paper aims to discuss and categorise different types of insulin pens, connected insulin pens and caps, as well as smart insulin pen systems (SPSs) that are available on the market. Connected pens capture data to provide information about the details of the insulin applied. SPSs are paired with a continuous glucose monitoring (CGM) system and, by means of integrated algorithms, can provide individualised dose calculation based on a variety of factors. These SPSs can also recommend insulin doses based on current and projected glucose and insulin data; this feature requires a connection to a CGM system. Yet what are the clinical advantages of SPSs? What added value does this system bring to individuals living with diabetes and their healthcare providers? In a narrative review, we discuss the current regulatory pathways and market environment as well as the influencing factors of connected insulin pens vs SPSs. We aim to provide a rationale and justification for this categorisation based on (smart) design aspects, regulatory considerations and clinical outcomes. This review concludes that while standard insulin pens remain a safe and commonly offered option, connected insulin pens and SPSs are likely to show improvement in glycaemic management, treatment adherence and patient satisfaction, and represent a significant advancement in diabetes care. However, further research including high-quality clinical and health economic studies will be vital in substantiating the value of both connected insulin pens and SPSs and driving broader acceptance among payers and healthcare systems.