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Background: Insulin degludec/insulin aspart (IDegAsp) is a fixed‐ratio co‐formulation of insulin degludec and insulin aspart for the treatment of people with diabetes and suboptimal glycaemic control. Few real‐world studies of IDegAsp treatment have been conducted. Here, we report results from the Australian cohort of the global ARISE study of real‐world IDegAsp use. Aims: To investigate glycaemic control and other clinical outcomes in people with type 2 diabetes (T2D) treated with IDegAsp in a real‐world setting in Australia. Methods: A total of 183 adults with T2D initiating or switching to IDegAsp in the Australian cohort of the open‐label, non‐interventional ARISE study were followed for 26–36 weeks from August 2019 to December 2020. Results: IDegAsp was associated with significant reductions from baseline to end of study (EOS) in mean glycated haemoglobin (estimated change −0.8% (95% confidence interval (CI): −1.05 to −0.56; P < 0.0001)), fasting plasma glucose (−1.6 mmol/L (95% CI: −2.49 to −0.63; P = 0.0017)) and body weight (−2.6 kg (95% CI: −3.68 to −1.55; P < 0.0001)). In insulin‐experienced patients, the mean total daily insulin dose did not change significantly (estimated change from baseline to EOS 3.8 (95% CI: –3.70 to 11.21; P = 0.3202)). The proportion of patients experiencing hypoglycaemia numerically decreased during the study (non‐severe: 14.2–10.9%; nocturnal non‐severe: 4.9–2.2%; and severe: 2.2–0%). Conclusions: Initiating or switching to IDegAsp in a real‐world population of people with T2D in Australia was associated with significant improvements in glycaemic control and body weight, and numerically lower levels of hypoglycaemia compared with baseline. [ABSTRACT FROM AUTHOR]

Aims: To examine the psychometric properties of the Diabetes Management Experiences Questionnaire (DME‐Q). Adapted from the validated Glucose Monitoring Experiences Questionnaire, the DME‐Q captures satisfaction with diabetes management irrespective of treatment modalities. Methods: The DME‐Q was completed by adults with type 1 diabetes as part of a randomized controlled trial comparing hybrid closed loop (HCL) to standard therapy. Most psychometric properties were examined with pre‐randomization data (n = 149); responsiveness was examined using baseline and 26‐week follow‐up data (n = 120). Results: Pre‐randomization, participants' mean age was 44 ± 12 years, 52% were women. HbA1c was 61 ± 11 mmol/mol (7.8 ± 1.0%), diabetes duration was 24 ± 12 years and 47% used an insulin pump prior to the trial. A forced three‐factor analysis revealed three expected domains, that is, 'Convenience', 'Effectiveness' and 'Intrusiveness', and a forced one‐factor solution was also satisfactory. Internal consistency reliability was strong for the three subscales (α range = 0.74–0.84) and 'Total satisfaction' (α = 0.85). Convergent validity was demonstrated with moderate correlations between DME‐Q 'Total satisfaction' and diabetes distress (PAID: rs = −0.57) and treatment satisfaction (DTSQ; rs = 0.58). Divergent validity was demonstrated with a weak correlation with prospective/retrospective memory (PRMQ: rs = −0.16 and − 0.13 respectively). Responsiveness was demonstrated, as participants randomized to HCL had higher 'Effectiveness' and 'Total satisfaction' scores than those randomized to standard therapy. Conclusions: The 22‐item DME‐Q is a brief, acceptable, reliable measure with satisfactory structural and construct validity, which is responsive to intervention. The DME‐Q is likely to be useful for evaluation of new pharmaceutical agents and technologies in research and clinical settings. [ABSTRACT FROM AUTHOR]

Objective: To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes).Research Design and Methods: Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks.Results: Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.Conclusions: In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous. [ABSTRACT FROM AUTHOR]

Less than 20% of Australians with type 1 diabetes (T1D) meet recommended glucose targets. Technology use is associated with better glycaemia, with the most advanced being automated insulin delivery (AID) systems, which are now recommended as gold-standard T1D care. Our Australian AID trial shows a wide spectrum of adults with T1D can achieve recommended targets. Other studies, including lived experience data, are supportive. Insulin pumps are not subsidised for most Australian adults with T1D. We advocate change., (© 2024 Royal Australasian College of Physicians.)

Introduction: This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy., Research Design and Methods: In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 670G) or standard therapy (insulin pump or multiple daily injections without real-time continuous glucose monitoring). Psychological outcomes (awareness and fear of hypoglycemia; and diabetes-specific positive well-being, diabetes distress, diabetes treatment satisfaction, and diabetes-specific quality of life (QoL)) were measured at enrollment, mid-trial and end-trial. Linear mixed models were conducted, using restricted maximum likelihood estimation, unadjusted and adjusted (for covariates: age, sex, diabetes duration, glycated hemoglobin, recent severe hypoglycemia, pre-trial insulin delivery modality, enrollment and mid-study scores)., Results: 120 participants (mean age 44±12 years) were randomized to intervention (n=61) or standard therapy (n=59). At 13 weeks, the HCL group had better diabetes-specific positive well-being than the standard therapy group (unadjusted: Δ=1.0, p=0.025; adjusted: Δ=1.1, p=0.01), which was maintained at 26 weeks (unadjusted: Δ=0.9, p=0.042; adjusted: Δ=1.0, p=0.023). At 26 weeks, the HCL group also had less diabetes distress (adjusted: Δ=-6.4, p=0.039), fear of hypoglycemia ("maintain high": adjusted: Δ=-0.8, p=0.034; and "worry": adjusted: Δ=-1.8, p=0.048), and perceived "unacceptably high glucose levels" (unadjusted: Δ=-1.1, p<0.001; adjusted: Δ=-1.1, p<0.001). HCL did not improve diabetes treatment satisfaction, diabetes-specific QoL, hypoglycemia awareness, or perceived frequency of unacceptably low glucose levels., Conclusions: These findings imply that HCL offers important psychological benefits. In particular, improvement in diabetes-specific positive well-being was observed 13 weeks after HCL initiation and maintained at 26 weeks. Reduction in the perceived frequency of hyperglycemia was also apparent by 26 weeks. Adjusted analyses showed significant reductions in diabetes distress and fear of hypoglycemia at 26 weeks, suggesting these benefits were apparent for people with particular characteristics., Trial Registration Number: Australian New Zealand Clinical Trials Registry: ACTRN12617000520336., Competing Interests: Competing interests: JAH reports speaker honoraria from Roche Diabetes Care. SAM reports support for research from Medtronic, speaker honoraria from Eli Lilly, Roche and Sanofi, and serving on advisory boards for Medtronic and Ypsomed. ST reports non-financial support from Abbott Diabetes Care. BP reports speaker honoraria fees from Medtronic. LAB reports grant funding from AstraZeneca. NDC reports personal fees from Medtronic and Abbott Laboratories and grant funds from Ypsomed Group. AJJ has received research support from Medtronic, Sanofi, Abbott Laboratories, and Mylan and has served on advisory boards for Medtronic, Sanofi, and Abbott Diabetes Care. JK reports speaker fees from Novo Nordisk and AstraZeneca and advisory board fees from Abbott Diabetes Care. MHL reports speaker honoraria from Medtronic. BP reports speaker honoraria fees from Medtronic. DO has served on advisory boards for Abbott Laboratories, Medtronic, Merck Sharp & Dohme, Novo Nordisk, Roche, and Sanofi; received research support from Medtronic, Novo Nordisk, Roche, Eli Lilly and Company, and Sanofi; and received travel support from Novo Nordisk and Merck Sharp & Dohme. JS has served on advisory boards for Insulet, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; her research group (The Australian Centre for Behavioural Research in Diabetes) has received honoraria for this advisory board participation and has also received unrestricted educational grants and/or in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; has received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes; and has received consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi Diabetes. The remaining authors do not report any potential conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)