To Örebro University

OBJECTIVE: The objective of this study was to estimate the 10-year clinical benefits and economic value of weight loss in a Swedish population with obesity using a value of weight-loss simulation model.

METHODS: Data on the prevalence of and costs associated with obesity and obesity-related complications (ORCs) were applied within an adapted simulation model to evaluate weight-loss benefits for a 2023 Swedish population over 10 years. The 10-year incidence of 10 ORCs and treatment costs in a random cohort of 10,000 individuals were estimated for a stable weight scenario and four weight-loss (5%-20%) scenarios.

RESULTS: The model included 887,272 individuals with obesity aged 20 to 60 years. Hypertension (24.1%), asthma (20.9%), dyslipidemia (18.3%), and type 2 diabetes (10.6%) were highly prevalent. For 10,000 individuals, a 5% to 20% weight loss was estimated to prevent ORCs over 10 years, leading to annual savings between 9.0 million Swedish krona (SEK)/€0.8 million (5% weight loss) and 30.0 million SEK/€2.6 million (20%) by 2033.

CONCLUSIONS: Annual treatment costs of ORCs in Sweden will double over 10 years, and weight loss would be associated with significant savings because of the reductions in the incidence of ORCs. Therefore, there is an urgent need to effectively treat obesity to prevent morbidity.

OBJECTIVE: The study aimed to investigate the impact of nutrient timing in relation to evening exercise. Specifically, it examined the effects of pre- or post-exercise carbohydrate (CHO) ingestion on glucose metabolism, glucose regulation, and overall substrate oxidation in well-trained athletes during and after physical exercise (PE), spanning the nocturnal period and the subsequent morning.

METHODS: Ten male endurance cyclists participated in the study. The initial assessments included body composition measurements and an incremental cycle test to determine maximal oxygen uptake (V˙O2 max) and maximum power output (Wmax). Following this, participants underwent a control (rest previous day) oral glucose tolerance test (OGTT) and a familiarization exercise trial that had two objectives: (1) to establish the appropriate amount of CHO to use in the pre- or post-exercise drink during the experimental trials, and (2) to familiarize participants with the equipment and study protocol. In the three days prior to both the control and experimental trials, participants followed a standardized, individualized diet designed to meet their energy needs. During the experimental trials, participants completed two separate evening exercise sessions (50 min@70%Wmax +  ~24 min time-trial (TT)) with either pre- or post-exercise CHO ingestion (253 ± 52 g), matching the CHO oxidized during exercise. The CHO drink and a volume-matched placebo (PLA) drink (containing no energy) were randomly assigned to be consumed two hours before and directly after the experimental exercise sessions. Post-exercise nocturnal interstitial glucose levels (24:00-06:00) were continuously monitored, and a 120-min OGTT was conducted the following morning to assess substrate oxidation rates and glucose control.

RESULTS: Pre-exercise CHO intake significantly lowered capillary glucose levels during steady-state exercise (mean difference 0.41 ± 0.27 mmol/L, p = 0.001) without affecting perceived exertion and TT-performance. No difference was observed in nocturnal glucose regulation (00:00-06:00) regardless of whether CHO was consumed before or after exercise. Post-exercise CHO ingestion reduced glucose tolerance during the OGTT compared to the iso-caloric pre-exercise CHO intake (mean difference 0.76 ± 0.21 mmol/L, p = 0.017). However, a post-exercise CHO intake improved respiratory exchange ratio/metabolic flexibility (MetF) significantly. Enhanced MetF during the first OGTT hour after post-exercise CHO ingestion resulted in 70% and 91% higher CHO oxidation compared to pre-exercise CHO and control, respectively (p ≤ 0.029). Average 120-min OGTT fat oxidation rates were higher with both pre- and post-exercise CHO ingestion compared to control (p ≤ 0.008), with no difference between pre- and post-exercise CHO intake.

CONCLUSION: Morning glucose tolerance was markedly reduced in healthy athletes when CHO was ingested after evening exercise. However, the observed improvements in MetF during the OGTT compared to placebo post-exercise suggest a potential for enhanced athletic performance in subsequent exercise sessions. This opens exciting possibilities for future research to explore whether enhanced MetF induced by CHO-timing can translate to improved athletic performance, offering new avenues for optimizing training and performance.

AIMS: Large-scale studies on the effectiveness of automated insulin delivery (AID) systems in older people with type 1 diabetes are still limited. A multinational, retrospective, real-world study was conducted to examine the performance of the MiniMed™ 780G advanced hybrid closed-loop system in users with type 1 diabetes aged ≥56 years compared with those aged 16-55 years.

MATERIALS AND METHODS: Data from 35 366 MiniMed™ 780G system users aged 16-55 years and 7415 users aged ≥56 years were included. The main outcome was time in range 70-180 mg/dL (TIR); other continuous glucose monitoring (CGM) metrics were also assessed.

RESULTS: Across all users, mean TIR was 77.1% for users aged ≥56 years and 73.1% for those aged 16-55 years (Δ4.0, 95% confidence interval [CI]: 3.8-4.2, p <0.0001). In users employing the optimal system settings (i.e., Glucose Target: 100 mg/dL; active insulin time: 2 h), mean TIR was 81.9% in older and 79.7% in younger users (Δ2.2, 95% CI: 1.5-2.9, p <0.0001). Across all users, mean time below range <70 mg/dL (TBR70) was 1.5% in older and 2.1% in younger users. In older users, TIR and TBR70 remained consistent over 12 months.

CONCLUSIONS: This real-world analysis demonstrated that older MiniMed™ 780G system users with type 1 diabetes can achieve a TIR >70% without increasing hypoglycaemia risk. Users employing optimal settings showed the best outcomes. The system performed as well as or better than in younger users. These findings support the case that more stringent TIR targets can be achieved safely.

Objectives: To prevent hypoglycemia, hyperglycemia and long-term diabetes com-plications, keeping glucose levels within range is essential for individuals with type 2 diabetes mellitus (T2DM). This is traditionally done by self-monitoring of blood glucose (SMBG), involving finger pricking. However, continuous glucose monitoring (CGM) devices using a glucose sensor allow for better glucose control and lower the risk of hypoglycemia and hyperglycemia versus SMBG. The objective of this study was to assess the budget impact of replacing SMBG with CGM devices in T2DM, from a Swedish healthcare perspective.

Methods: A budget impact model with a 5-year time horizon was developed to compare the costs associated with SMBG versus real-time CGM (rtCGM), and intermittent-scanning CGM (isCGM). The model population was based on the Swedish T2DM prevalence, annual incidence and CGM eligibility. Cost categories included device acquisition, drug acquisition, consumables, adverse events (AEs) and diabetes complications. Cost inputs were based on Swedish sources. Incidence of AEs were derived from the devices’ pivotal trials. The incidence of complications was based on risk equations, which were informed by patient characteristics and change in glucose levels based on a network meta-analysis between rtCGM, isCGM, and SMBG.

Results: 105,000 hypothetical Swedish individuals with T2DM entered the model in year 1. Over a 5-year time horizon, replacing SMBG with rtCGM and isCGM led to cost savings of SEK 68,000,000, primarily due to lower costs for medication, AEs, and diabetes complications. rtCGM was associated with the highest cost savings thanks to better glycemic control, resulting in fewer diabetes complications versus SMBG and isCGM.

Conclusions: Controlling glucose levels with CGM, and with rtCGM particularly, could lower overall treatment costs in T2DM. In a disease area with rising prevalence, these savings highlight the potential for substantial economic benefit to the Swedish healthcare system by switching individuals with T2DM from SMBG to CGM.

People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals.

Aims: The objective was to compare anxiety, depression, and quality of life (QoL) in individuals living with type 1 (T1D) and type 2 (T2D) diabetes with matched controls during the second wave of the COVID-19 pandemic.

Methods: Via randomization, individuals living with diabetes T1D (n = 203) and T2D (n = 413), were identified during February-July 2021 through health-care registers. Population controls (n = 282) were matched for age, gender, and residential area. Questionnaires included self-assessment of anxiety, depression, QoL, and demographics in relation to SARS-CoV-2 exposure. Blood was collected through home-capillary sampling, and SARS-CoV-2 Nucleocapsid (NCP) and Spike antibodies (SC2_S1) were determined by multiplex Antibody Detection by Agglutination-PCR (ADAP) assays.

Results: Younger age and health issues were related to anxiety, depression, and QoL, with no differences between the study groups. Female gender was associated with anxiety, while obesity was associated with lower QoL. The SARS-CoV-2 NCP seroprevalence was higher in T1D (8.9 %) compared to T2D (3.9 %) and controls (4.0 %), while the SARS-CoV-2 SC2_S1 seroprevalence was higher for controls (25.5 %) compared to T1D (16.8 %) and T2D (14.0 %).

Conclusions: A higher SARS-CoV-2 infection rate in T1D may be explained by younger age and higher employment rate, and the associated increased risk for viral exposure.

AIM: To evaluate whether both bolus insulin injection frequency and smart pen engagement were associated with changes in glycaemic control, using real-world data from adults with type 1 diabetes (T1D).

MATERIALS AND METHODS: Adults using a smart pen (NovoPen 6) to administer bolus insulin (fast-acting insulin aspart or insulin aspart) alongside continuous glucose monitoring were eligible for inclusion. Smart pen engagement was characterized by number of days with pen data uploads over the previous 14 days. Glycaemic control was evaluated by analysing glucose metrics.

RESULTS: Overall, data from 1194 individuals were analysed. The number of daily bolus injections was significantly associated with time in range (TIR; 3.9-10.0 mmol/L [70-180 mg/dL]; P < 0.0001). Individuals administering, on average, three daily bolus insulin injections had an estimated 11% chance of achieving >70% TIR. The probability of achieving >70% TIR increased with the mean number of daily bolus injections. However, the percentage of TIR was lower on days when individuals administered higher-than-average numbers of injections. The observed mean number of daily bolus injections administered across the study population was lower than the optimal number required to reach glycaemic targets (4.8 injections vs. 6-8 injections). Smart pen engagement was significantly associated with improved TIR.

CONCLUSIONS: Glycaemic control was associated with daily bolus insulin injection frequency and smart pen engagement. A treatment regimen combining an optimal bolus injection strategy, and effective smart pen engagement, may improve glycaemic control among adults with T1D.

Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.

This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.

Background and aims: Automated insulin delivery (AID) systems help people living with diabetes (PwD) manage their glucose levels using automated insulin dose adjustment. Numerous studies provide evidence on AID systems effectiveness and the significant improvement of glycemic outcomes across diverse PwD populations. The aim of this study is to assess both the clinical and economic impact of AID compared to multiple daily insulin (MDI) or continuous subcutaneous insulin infusion (CSII) treatments in conjunction with continuous glucose monitoring (CGM) in Sweden.

Materials and methods: The IQVIA Core Diabetes Model v.10 was used to simulate 1000 individuals from different groups; pediatrics with type 1 diabetes (T1D), adults with uncontrolled T1D and adults with uncontrolled type 2 diabetes (T2D) on MDI across several time horizons (5, 15, 30 and 50 years). The corresponding mean baseline HbA1c levels in each group were 7.30%, 9.04% and 9.13%. After being randomized to an AID system all groups showed significant reductions of HbA1c levels: -0.40% vs. CSII+CGM, -1.42% vs. MDI+CGM and -1.30% vs. MDI + CGM respectively.

Results: The results suggest that across all time horizons AID therapy was associated with increased quality-adjusted life years (QALYs), risk reductions for long-term complications and direct cost savings. At 50 years, 22% [standard deviation (sd): 1.9%], 41% [sd: 1.9%] and 24% [sd: 2.4%] of events were averted in the pediatrics T1D, uncontrolled adults T1D and uncontrolled adults with T2D respectively. Direct costs were also reduced for all groups ranging from -8% to -22%. Incremental cost effectiveness ratio (ICER) for a 50 years’ time horizon was calculated based on QALY gains and total accumulated costs, resulting in -225,260 SEK/QALY [95% CI: -423,819 to -26,701] for the pediatric group, 154,684 SEK/QALY [95% CI: 139,594 to 169,774] for the uncontrolled T1D group and 562,065 SEK/QALY [95% CI: 507,326 to 616,803] for the uncontrolled T2D.

Conclusion: From a clinical perspective the analyzed groups would benefit from the use of AID systems, with risk reductions in diabetes-related complications both in the short- and in the long term. From an economic perspective, at a willingness-to-pay threshold of 500,000 SEK per QALY, AID systems are a cost-effective alternative to CSII and MDI in the pediatrics T1D, and uncontrolled adults T1D, and possibly cost-effective for uncontrolled T2D patient populations in Sweden. Therefore, AID systems are the therapeutic option that offer the maximum health gain while balancing health care costs for pediatrics and uncontrolled T1D and T2D on MDI.