Ageing well with diabetes: the role of technology.

Over the past two decades there has been a substantial rise in the adoption of diabetes therapeutic technology among children, adolescents and younger adults with type 1 diabetes, and its use is now also advocated for older individuals. Older people with diabetes are more prone to experience hypoglycaemia because of numerous predisposing factors and are at higher risk of hypoglycaemic events requiring third-party assistance as well as other adverse sequelae. Hypoglycaemia may also have long-term consequences, including cognitive impairment, frailty and disability. Diabetes in older people is often characterised by marked glucose variability related to age-associated changes such as variable appetite and levels of physical activity, comorbidities and polypharmacotherapy. Preventing hypoglycaemia and mitigating glucose excursions may have considerable positive impacts on physical and cognitive function and general well-being and may even prevent or improve frailty. Technology for older people includes continuous glucose monitoring systems, insulin pumps, automated insulin delivery systems and smart insulin pens. Clinical trials and real-world studies have shown that older people with diabetes benefit from technology in terms of glucose management, reductions in hypoglycaemic events, emergency department attendance and hospital admissions, and improvement in quality of life. However, ageing may bring physical impairments and other challenges that hinder the use of technology. Healthcare professionals should identify older adults with diabetes who may benefit from therapeutic technology and then adopt an individualised approach to education and follow-up for individuals and their caregivers. Future research should explore the impact of diabetes technology on outcomes relevant to older people with diabetes.

Real-world lived experience of older adults with type 1 diabetes after an automated insulin delivery trial.

AIMS: First-generation closed-loop automated insulin delivery improves glycaemia and psychosocial outcomes among older adults with type 1 diabetes in clinical trials. However, no study has previously assessed real-world lived experience of older adults using closed-loop therapy outside a trial environment. METHODS: Semi-structured interviews were conducted with older adults who were pre-existing insulin pump users and previously completed the OldeR Adult Closed-Loop (ORACL) randomised trial. Interviews focused on perceptions of diabetes technology use, and factors influencing decisions regarding continuation. RESULTS: Twenty-eight participants, mean age 70 years (SD 5), were interviewed at median 650 days (IQR 608-694) after their final ORACL trial visit. At interview, 23 participants (82%) were still using a commercial closed-loop system (requiring manual input for prandial insulin bolus doses). Themes discussed in interviews relating to closed-loop system use included sustained psychosocial benefits, cost and retirement considerations and usability frustrations relating to sensor accuracy and system alarms. Of the five participants who had discontinued, reasons included cost, continuous glucose monitoring-associated difficulties and usability frustrations. Cost was the largest consideration regarding continued use; most participants considered the increased ease of diabetes management to be worth the associated costs, though cost was prohibitive for some. CONCLUSIONS: Almost 2 years after completing a closed-loop clinical trial, closed-loop automated insulin delivery remains the preferred type 1 diabetes therapy for the majority of older adult participants. Chronological age is not a barrier to real-world successful use of diabetes technology. Identifying age-related barriers, and solutions, to diabetes technology use among older adults is warranted.

The diabetes management experiences questionnaire: Psychometric validation among adults with type 1 diabetes.

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.

Lived experience of older adults with type 1 diabetes using closed-loop automated insulin delivery in a randomised trial.

AIM: To explore the lived experience of older adults with type 1 diabetes using closed-loop automated insulin delivery, an area previously receiving minimal attention. METHODS: Semi-structured interviews were conducted with adults aged 60 years or older with long-duration type 1 diabetes who participated in a randomised, open-label, two-stage crossover trial comparing first-generation closed-loop therapy (MiniMed 670G) versus sensor-augmented pump therapy. Interview recordings were transcribed, thematically analysed and assessed. RESULTS: Twenty-one older adults participated in interviews after using closed-loop therapy. Twenty were functionally independent, without frailty or major cognitive impairment; one was dependent on caregiver assistance, including for diabetes management. Quality of life benefits were identified, including improved sleep and reduced diabetes-related psychological burden, in the context of experiencing improved glucose levels. Gaps between expectations and reality of closed-loop therapy were also experienced, encountering disappointment amongst some participants. The cost was perceived as a barrier to continued closed-loop access post-trial. Usability issues were identified, such as disruptive overnight alarms and sensor inaccuracy. CONCLUSIONS: The lived experience of older adults without frailty or major cognitive impairment using first-generation closed-loop therapy was mainly positive and concordant with glycaemic benefits found in the trial. Older adults' lived experience using automated insulin delivery beyond trial environments requires exploration; moreover, the usability needs of older adults should be considered during future device development.

What difference does sleep make? Continuous glucose monitoring metrics during fixed-overnight time versus sleep periods among older adults with type 1 diabetes.

Hypoglycaemia during sleep is a common and clinically important issue for people living with insulin-treated diabetes. Continuous glucose monitoring devices can help to identify nocturnal hypoglycaemia and inform treatment strategies. However, sleep is generally inferred, with diabetes researchers and physicians using a fixed-overnight period as a proxy for sleep-wake status when analysing and interpretating continuous glucose monitoring data. No study to date has validated such an approach with established sleep measures. Continuous glucose monitoring and research-grade actigraphy devices were worn and sleep diaries completed for 2 weeks by 28 older adults (mean age 67 years [SD 5]; 17 (59%) women) with type 1 diabetes. Using continuous glucose monitoring data from a total of 356 nights, fixed-overnight (using the recommended period of 00:00 hours-06:00 hours) and objectively-measured sleep periods were compared. The fixed-overnight period approach missed a median 57 min per night (interquartile range: 49-64) of sleep for each participant, including five continuous glucose monitoring-detected hypoglycaemia episodes during objectively-measured sleep. Twenty-seven participants (96%) had at least 1 night with continuous glucose monitoring time-in-range and time-above-range discrepancies both ≥ 10 percentage points, a clinically significant discrepancy. The utility of fixed-overnight time continuous glucose monitoring as a proxy for sleep-awake continuous glucose monitoring is inadequate as it consistently excludes actual sleep time, obscures glycaemic patterns, and misses sensor hypoglycaemia episodes during sleep. The use of validated measures of sleep to aid interpretation of continuous glucose monitoring data is encouraged.

Reinforcement Sensitivity Theory of Personality Questionnaire: Factor Structure Based on CFA and ESEM, and Associations with ADHD.

Revised reinforcement sensitivity theory (r-RST) of personality is a major neuropsychological theory of motivation, emotion and personality. This paper presents the results of a study examining: (1) the factor structure of the Reinforcement Sensitivity Theory of Personality Questionnaire (RST-PQ) using confirmatory factor analysis (CFA) and exploratory structural equation modeling (ESEM); and (2) the relationships of the r-RST constructs in the RST-PQ with attention deficit hyperactivity disorder (ADHD) symptom groups of inattention (IA) and hyperactivity/impulsivity (HI). A total of 572 (Sample 1) and 309 (Sample 2) adults completed the RST-PQ. Participants in Sample 2 also completed a questionnaire measuring ADHD symptoms. Results revealed more support for the ESEM model with six factors than the CFA model. For both the ESEM and CFA models, both IA and HI symptom groups were associated positively with the RST-PQ constructs of behavioral inhibition system (BIS) and behavioral approach system (BAS) Impulsivity, with IA also associated negatively with the BAS-Goal-Drive Persistence. The theoretical implications of these findings for understanding the factor structure of the RST-PQ, and for ADHD (IA and HI) in terms of r-RST, are discussed.

Dementia in older people admitted to hospital: An analysis of length of stay and associated costs.

OBJECTIVES: Patients with dementia in the acute setting are generally considered to impose higher costs on the health system compared to those without the disease largely due to longer length of stay (LOS). Many studies exploring the economic impact of the disease extrapolate estimates based on the costs of patients diagnosed using routinely collected hospital discharge data only. However, much dementia is undiagnosed, and therefore in limiting the analysis to this cohort, we believe that LOS and the associated costs of dementia may be overestimated. We examined LOS and associated costs in a cohort of patients specifically screened for dementia in the hospital setting. METHODS: Using primary data collected from a prospective observational study of patients aged ≥70 years, we conducted a comparative analysis of LOS and associated hospital costs for patients with and without a diagnosis of dementia. RESULTS: There was no significant difference in overall length of stay and total costs between those with (µ = 9.9 days, µ = € 8246) and without (µ = 8.25 days, µ = € 6855) dementia. Categorical data analysis of LOS and costs between the two groups provided mixed results. CONCLUSIONS: The results challenge the basis for estimating the costs of dementia in the acute setting using LOS data from only those patients with a formal dementia diagnosis identified by routinely collected hospital discharge data. Accurate disease prevalence data, encompassing all stages of disease severity, are required to enable an estimation of the true costs of dementia in the acute setting based on LOS.

Prospective memory while driving: comparison of time- and event-based intentions.

Prospective memories can divert attentional resources from ongoing activities. However, it is unclear whether these effects and the theoretical accounts that seek to explain them will generalise to a complex real-world task such as driving. Twenty-four participants drove two simulated routes while maintaining a fixed headway with a lead vehicle. Drivers were given either event-based (e.g. arriving at a filling station) or time-based errands (e.g. on-board clock shows 3:30). In contrast to the predominant view in the literature which suggests time-based tasks are more demanding, drivers given event-based errands showed greater difficulty in mirroring lead vehicle speed changes compared to the time-based group. Results suggest that common everyday secondary tasks, such as scouting the roadside for a bank, may have a detrimental impact on driving performance. The additional finding that this cost was only evident with the event-based task highlights a potential area of both theoretical and practical interest. Practitioner Summary: Drivers were given either time- or event-based errands whilst engaged in a simulated drive. We examined the effect of errands on an ongoing vehicle follow task. In contrast to previous non-driving studies, event-based errands are more disruptive. Common everyday errands may have a detrimental impact on driving performance.

Dementia in older people admitted to hospital: a regional multi-hospital observational study of prevalence, associations and case recognition.

BACKGROUND: Previous studies have indicated a prevalence of dementia in older admissions of ∼42% in a single London teaching hospital, and 21% in four Queensland hospitals. However, there is a lack of published data from any European country on the prevalence of dementia across hospitals and between patient groups. OBJECTIVE: To determine the prevalence and associations of dementia in older patients admitted to acute hospitals in Ireland. METHODS: Six hundred and six patients aged ≥70 years were recruited on admission to six hospitals in Cork County. Screening consisted of Standardised Mini-Mental State Examination (SMMSE); patients with scores <27/30 had further assessment with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Final expert diagnosis was based on SMMSE, IQCODE and relevant medical and demographic history. Patients were screened for delirium and depression, and assessed for co-morbidity, functional ability and nutritional status. RESULTS: Of 598 older patients admitted to acute hospitals, 25% overall had dementia; with 29% in public hospitals. Prevalence varied between hospitals (P < 0.001); most common in rural hospitals and acute medical admissions. Only 35.6% of patients with dementia had a previous diagnosis. Patients with dementia were older and frailer, with higher co-morbidity, malnutrition and lower functional status (P < 0.001). Delirium was commonly superimposed on dementia (57%) on admission. CONCLUSION: Dementia is common in older people admitted to acute hospitals, particularly in acute medical admissions, and rural hospitals, where services may be less available. Most dementia is not previously diagnosed, emphasising the necessity for cognitive assessment in older people on presentation to hospital.

Treatment Satisfaction With Omnipod DASH in Adults With Type 1 Diabetes: A Nonblinded 1:1 Randomized Controlled Trial.

CONTEXT: Omnipod DASH Insulin Management System is a tubeless insulin pump that overcomes the physical inconveniences of conventional tubed insulin pump therapy (IPT). OBJECTIVE: We compared treatment satisfaction with Omnipod DASH System to usual care (multiple daily injections [MDIs] or tubed IPT) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG). METHODS: Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from 4 diabetes centers in Australia were randomly assigned in a 1:1 nonblinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension during which all participants used the device. The primary outcome was treatment satisfaction assessed by change in Diabetes Technology Questionnaire "current" (ΔDTQ-current) score at 12 weeks (study end). Secondary outcomes included ΔDTQ-current following extension and other participant-reported outcomes (PROs) measuring quality of life, burden of disease treatment, and glycemic and device-related outcomes at 12 weeks (study end) and 24 weeks (end extension). RESULTS: Treatment satisfaction improved more in the Omnipod group vs the Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs 0.0 [12.8]; P < .001) at study end. Significantly greater improvements in other PROs and glycated hemoglobin A1c were also observed. Improvements in DTQ-current and other PROs comparing study end and end extension were similar. While percentage in time in range change from baseline did not differ at study end (-2.0 [12.7] %), it was significantly greater at end extension (5.6 [10.9] %; P = .016). CONCLUSION: The Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG that was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed.

"You can hide it if you want to, you can let it be seen if you want to": A qualitative study of the lived experiences of Australian adults with type 1 diabetes using the Omnipod DASH® system.

AIMS: Understanding the lived experience of using a tubeless insulin pump and how this differs compared to usual care (tubed insulin pump therapy (IPT) vs multiple daily injections (MDI)). METHODS: Interviews were conducted after 12-weeks of using the Omnipod DASH Insulin Management System (Insulet, Acton, MA) and analysed using thematic analysis. RESULTS: Fifty-eight adults (35 female; mean age 42;SD 13 years; 35 previous MDI) were interviewed. Most (84 %) wanted to continue using the device. Experiences fit two themes: 1. Taking back control of my diabetes: many previous MDI users perceived improved glycaemic control, explained by more "nuanced" control, with some reporting positive effects during exercise and sleep. Many previous MDI and IPT users endorsed positive experiences in concealing or disclosing their diabetes to others. However, some previous MDI users reported negative psychosocial experiences due to feeling continuously "attached" to their diabetes. 2. Barriers and facilitators of device acceptability: both MDI and IPT users cited wearability, alarms and the financial cost impacted their choice to continue device use. IPT users reported positive wearability experiences. CONCLUSIONS: The tubeless pump improved diabetes management perceptions for both MDI and tubed pump users. However, participants' prior glucose management affected perceptions of its advantages and disadvantages.

Driving-Related Glucose Patterns Among Older Adults with Type 1 Diabetes.

Older adults with type 1 diabetes may face challenges driving safely. Glucose "above-5-to-drive" is often recommended for insulin-treated diabetes to minimize hypoglycemia while driving. However, the effectiveness of this recommendation among older adults has not been evaluated. Older drivers with type 1 diabetes were assessed while using sensor-augmented insulin pumps during a 2-week clinical trial run-in. Twenty-three drivers (median age 69 years [interquartile range; IQR 65-72]; diabetes duration 37 years [20-45]) undertook 618 trips (duration 10 min [5-21]). Most trips (n = 535; 87%) were <30 min duration; 9 trips (1.5%) exceeded 90 min and 3 trips (0.5%) exceeded 120 min. Pre-trip continuous glucose monitoring (CGM) was >5.0 mmol/L for 577 trips (93%) and none of these had CGM <3.9 mmol/L during driving (including 8 trips >90 min and 3 trips >120 min). During 41 trips with pre-trip CGM ≤5.0 mmol/L, 11 trips had CGM <3.9 mmol/L. Seventy-one CGM alerts occurred during 60 trips (10%), of which 54 of 71 alerts (76%) were unrelated to hypoglycemia. Our findings support a glucose "above-5-to-drive" recommendation to avoid CGM-detected hypoglycemia among older drivers, including for prolonged drives, and highlight the importance of active CGM low-glucose alerts to prevent hypoglycemia during driving. Driving-related CGM usability and alert functionality warrant investigation. Clinical trial ACTRN1261900515190.

Improved Satisfaction While Maintaining Safety and High Time in Range (TIR) With a Medtronic Investigational Enhanced Advanced Hybrid Closed-Loop (e-AHCL) System.

OBJECTIVE: To determine feasibility and compare acceptance of an investigational Medtronic enhanced advanced hybrid closed-loop (e-AHCL) system in adults with type 1 diabetes with earlier iterations. RESEARCH DESIGN AND METHODS: This nonrandomized three-stage (12 weeks each) exploratory study compared e-AHCL (Bluetooth-enabled MiniMed 780G insulin pump with automatic data upload [780G] incorporating an updated algorithm; calibration-free all-in-one disposable sensor; 7-day infusion set) preceded by a run-in (non-Bluetooth 780G [670G V4.0 insulin pump] requiring manual data upload; Guardian Sensor 3 [GS3] requiring calibration; 3-day infusion set), stage 1 (780G; GS3; 3-day infusion set), and stage 2 (780G; calibration-free Guardian Sensor 4; 3-day infusion set). Treatment satisfaction was assessed by Diabetes Technology Questionnaire (DTQ)-current (primary outcome) and other validated treatment satisfaction tools with glucose outcomes by continuous glucose monitoring metrics. RESULTS: Twenty-one of 22 (11 women) participants (baseline HbA1c 6.7%/50 mmol/mol) completed the study. DTQ-current scores favored e-AHCL (123.1 [17.8]) versus run-in (101.6 [24.2]) and versus stage 1 (110.6 [20.8]) (both P < 0.001) but did not differ from stage 2 (119.4 [16.0]; P = 0.271). Diabetes Medication System Rating Questionnaire short-form scores for "Convenience and Efficacy" favored e-AHCL over run-in and all stages. Percent time in range 70-180 mg/dL was greater with e-AHCL versus run-in and stage 2 (+2.9% and +3.6%, respectively; both P < 0.001). Percent times of <70 mg/dL for e-AHCL were significantly lower than run-in, stage 1, and stage 2 (-0.9%, -0.6%, and -0.5%, respectively; all P < 0.01). CONCLUSIONS: e-AHCL was feasible. User satisfaction increased compared with earlier Medtronic HCL iterations without compromising glucose control.

A pilot randomised controlled parallel arm trial evaluating treatment satisfaction with the Omnipod DASH® Insulin Management System compared with usual care in adults with type 1 diabetes in Australia: rationale, study design and methodologies.

BACKGROUND: Insulin pump therapy (IPT) improves glucose control in people with type 1 diabetes (T1D) compared with multiple daily injections (MDI). However, their size, the tethered insulin infusion set, intrusiveness when operating the device and the need to disconnect during showering limit their acceptance to many who may benefit. The Omnipod DASH® Insulin Management System is a small waterproof tubeless device which is wirelessly controlled by a handheld device which may be an acceptable alternative. However, there are no randomised controlled trials focusing on the impact on user perceptions of tubeless insulin pump therapy. This pilot study aims to assess study feasibility and acceptability of patch pump therapy compared with usual care in adults with T1D in Australia to inform power calculations and progression to a large-scale multi-site randomised controlled study. METHODS: A pilot multi-site parallel randomised controlled study will be conducted in sixty-four adults with T1D who are managed on MDI or IPT and self-monitoring with finger-stick blood glucose from four specialist diabetes centres in Victoria, Australia. Following carbohydrate counting education, participants will be randomised to use Omnipod DASH® System (Omnipod group) or continue usual care (usual care group) for 12 weeks, followed by a 12-week extension phase where all participants will use Omnipod DASH® System. The primary outcome measure is feasibility determined by study completion rates with a threshold of 0.80. Acceptability of the intervention (Omnipod DASH® System) will be assessed by the difference in Diabetes Technology Questionnaire 'current' (DTQ-current) score at 12 weeks post-randomisation compared to baseline. Secondary outcomes will include other measures of user acceptance, process outcomes, resource outcomes, participant-centred outcomes, healthcare professional perceptions and glycaemic outcomes. DISCUSSION: This pilot study will provide insights regarding the feasibility of the study design and the first data regarding user acceptance of insulin patch pump technology in Australian T1D adults. We anticipate that this study will provide information informing the design of a larger study evaluating the impact of patch pumps on subjective outcomes that are of significance to the person living with T1D. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( https://anzctr.org.au/ ) ACTRN12621001195842 (8th September 2021). Please refer to Additional file 1: Appendix 1 for full details.

Self-reported changes in aggressive driving within the past five years, and during COVID-19.

Aggressive driving is a significant road safety problem and is likely to get worse as the situations that provoke aggression become more prevalent in the road network (e.g. as traffic volumes and density increase and the grey fleet expands). In addition, driver frustration and stress, also recognised as triggers for aggression, are likely to stay high because of the COVID-19 pandemic and associated burdens, leading to increased aggression. However, although drivers report that other drivers are becoming more aggressive, self-report data suggests that the prevalence of aggression has not changed over time. This may be due to the methods used to define and measure aggression. This study sought to clarify whether self-reported aggression has increased over a five-year period and across three different types of aggression: verbal aggression, aggressive use of the vehicle and personal physical aggression. The influence of COVID-19 lockdowns on own and others' driving styles was also investigated. A total of 774 drivers (males = 66.5%, mean age = 48.7; SD = 13.9) who had been licensed for at least five years (M = 30.6, SD = 14.3), responded to an online survey and provided retrospective frequencies for their current aggression (considered pre-COVID-19 lockdowns) and five years prior. Two open ended questions were included to understand perceived changes in driving styles (own and others) during the COVID-19 pandemic. One third (33%) of drivers believed they were more aggressive now than five years ago but 61% of the sample believed other drivers were more aggressive now than five years ago. Logistic regression analyses on changes in self-reported aggression (same or decreased vs increased) showed the main factor associated with increases in aggressive driving was the perception that other drivers' aggression had increased. Further, almost half the sample (47%) reported that other drivers had become riskier and more dangerous during, and soon after, the COVID-19 lockdowns. These results show that the driving environment is seen as becoming more aggressive, both gradually and as a direct result of COVID-19 lockdowns. The data indicate that this perceived increase in aggression is likely to provoke higher levels of aggression in some drivers. Campaigns to reduce aggression on the roads need to focus on changing road culture and improving interactions, or perceived interactions, among road users.

Glucose profiles of older adults with type 1 diabetes using sensor-augmented pump therapy in Australia: pre-randomisation results from the ORACL study.

BACKGROUND: Older adults with type 1 diabetes are recommended modified glucose targets. However, data on the effects of diabetes technology in older age are scarce. We assessed older adults established on sensor-augmented insulin pump therapy during clinical trial run-in and compared their continuous glucose monitoring (CGM) profiles with consensus recommendations. We aimed to provide insight into the applicability of currently recommended CGM-based targets while accounting for current Diabetes UK guidelines. METHODS: In this analysis, adults aged 60 years or older with type 1 diabetes with a duration of at least 10 years and entering the Older Adult Closed Loop (ORACL) trial were studied. The trial was done at two tertiary hospitals in Australia. Individuals who were independent with diabetes self-management, as well as those receiving caregiver assistance for their diabetes management, were eligible for inclusion. Participants underwent baseline clinical assessment, which included medical history and examination, testing for frailty, functional ability, cognitive functioning, psychosocial wellbeing, and subjective sleep quality; fasting venous blood samples were collected for C-peptide, glucose, and glycated haemoglobin A1c measurement. Sensor-augmented pumps, carbohydrate-counting education, and diabetes education were provided to participants by diabetes nurse educators, dietitians, and endocrinologists experienced in type 1 diabetes clinical care. CGM data were subsequently collected for 2 weeks during sensor-augmented pump therapy. The ORACL trial is registered with the Australian New Zealand Clinical Trial Registry, ACTRN12619000515190. FINDINGS: Our analysis included all 30 participants who completed the ORACL trial run-in-19 (63%) women and 11 (37%) men (mean age 67 years [SD 5], median diabetes duration 38 years [IQR 20-47], and insulin total daily dose 0·55 units [0·41-0·66] per kg bodyweight). Ten (33%) of 30 participants had impaired hypoglycaemia awareness and six (20%) were pre-frail; none were frail. The median CGM time in range 3·9-10·0 mmol/L was 71% (IQR 64-79). The time spent with glucose above 10·0 mmol/L was 27% (18-35) and above 13·9 mmol/L was 3·9% (2·4-10·2). The time with glucose below 3·9 mmol/L was 2·0% (1·2-3·1) and the time below 3·0 mmol/L was 0·2% (0·1-0·4). Only two (7%) of 30 participants met all CGM-based consensus recommendations modified for older adults. Time in hypoglycaemia was lower among the 16 participants with predictive low-glucose alerts enabled than among the 14 participants not using predictive low-glucose alerts (median difference -1·1 percentage points [95% CI -2·0 to -0·1]; p=0·038). This difference was even greater overnight (-2·3 percentage points [-3·2 to -1·0]; p=0·0018). One serious adverse event occurred (elective cardiac stent). INTERPRETATION: Using sensor-augmented pumps after multidisciplinary education, this group of older adults without frailty achieved a time in range far exceeding minimum consensus recommendations. However, the current stringent hypoglycaemia recommendations for all older adults were not met. Predictive low alerts could reduce hypoglycaemia, particularly overnight. Investigation into the effectiveness of CGM-based targets that consider frailty, functional status, and diabetes therapies for older adults is warranted. FUNDING: JDRF and Diabetes Australia.

Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial.

OBJECTIVE: To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: This open-label, randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range (TIR; 3.9-10.0 mmol/L). RESULTS: There were 30 participants (mean age 67 [SD 5] years), with median type 1 diabetes duration of 38 years (interquartile range [IQR] 20-47), randomized (n = 15 to each sequence); all completed the trial. The mean TIR was 75.2% (SD 6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference of 6.2 percentage points [95% CI 4.4 to 8.0]; P < 0.0001). All prespecified CGM metrics favored closed loop over the sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (95% CI 0.3 to 1.1; P = 0.0005) and overnight by 0.8 percentage points (0.4 to 1.1; P < 0.0001) compared with sensor-augmented pump. There was no significant difference in HbA1c between closed-loop versus sensor-augmented pump stages (7.3% [IQR, 7.1-7.5] (56 mmol/mol [54-59]) vs. 7.5% [7.1-7.9] (59 mmol/mol [54-62]), respectively; P = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage. CONCLUSIONS: Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.

Closed-Loop Insulin Delivery Effects on Glycemia During Sleep and Sleep Quality in Older Adults with Type 1 Diabetes: Results from the ORACL Trial.

Sleep-related effects of closed-loop therapy among older adults with type 1 diabetes have not been well established. In the OldeR Adult Closed-Loop (ORACL) randomized, crossover trial of first-generation closed-loop therapy (MiniMed 670G), participants wore actigraphy and completed sleep diaries for 14-day periods at stage end. During objectively measured sleep (actigraphy) with closed-loop versus sensor-augmented pump therapy, glucose time-in-range 70-180 mg/dL (3.9-10.0 mmol/L) was greater (90.3% vs. 78.7%, respectively; difference 8.2 percentage points [95% confidence interval {CI} 1.5 to 13.0]; P = 0.008), and there were fewer sensor hypoglycemia episodes (18 vs. 43, respectively; incident rate ratio 0.40 [95% CI 0.20 to 0.55]; P = 0.007). Sleep quality recorded daily was worse with closed-loop therapy (P = 0.006); Pittsburgh Sleep Quality Index did not differ. There were 30% more system alarms during monitored sleep with closed-loop therapy (P < 0.001). First-generation closed-loop therapy has important glycemic benefits during sleep for older adults, with deterioration in some sleep quality measures. Sleep quality warrants prioritization and investigation during advancement of closed-loop technology.

Driving with Type 1 Diabetes: Real-World Evidence to Support Starting Glucose Level and Frequency of Monitoring During Journeys.

There is limited evidence supporting the recommendation that drivers with insulin-treated diabetes need to start journeys with glucose >90 mg/dL. Glucose levels of drivers with type 1 diabetes were monitored for 3 weeks using masked continuous glucose monitoring (CGM). Eighteen drivers (median [IQR] age 40 [35, 51] years; 11 men) undertook 475 trips (duration 15 [13, 21] min). Hypoglycemia did not occur in any trip starting with glucose >90 mg/dL (92%; n = 436). Thirteen drivers recorded at least one trip (total n = 39) starting with glucose <90 mg/dL. Among these, driving glucose was <70 mg/dL in five drivers (38%) during 10 trips (26%). Among five drivers (28%), a ≥ 36 mg/dL drop was observed within 20 min of starting their journey. Journey duration was positively associated with maximum glucose change. These findings support current guidelines to start driving with glucose >90 mg/dL, and to be aware that glucose levels may change significantly within 20 min. A CGM-based, in-vehicle display could provide glucose information and alerts that are compatible with safe driving. Clinical Trial Registration number: ACTRN12617000520336.

Multitasking: multiple, domain-specific cognitive functions in a virtual environment.

Multitasking among three or more different tasks is a ubiquitous requirement of everyday cognition, yet rarely is it addressed in research on healthy adults who have had no specific training in multitasking skills. Participants completed a set of diverse subtasks within a simulated shopping mall and office environment, the Edinburgh Virtual Errands Test (EVET). The aim was to investigate how different cognitive functions, such as planning, retrospective and prospective memory, and visuospatial and verbal working memory, contribute to everyday multitasking. Subtasks were chosen to be diverse, and predictions were derived from a statistical model of everyday multitasking impairments associated with frontal-lobe lesions (Burgess, Veitch, de Lacy Costello, & Shallice, 2000b). Multiple regression indicated significant independent contributions from measures of retrospective memory, visuospatial working memory, and online planning, but not from independent measures of prospective memory or verbal working memory. Structural equation modelling showed that the best fit to the data arose from three underlying constructs, with Memory and Planning having a weak link, but with both having a strong directional pathway to an Intent construct that reflected implementation of intentions. Participants who followed their preprepared plan achieved higher scores than those who altered their plan during multitask performance. This was true regardless of whether the plan was efficient or poor. These results substantially develop and extend the Burgess et al. (2000b) model to healthy adults and yield new insight into the poorly understood area of everyday multitasking. The findings also point to the utility of using virtual environments for investigating this form of complex human cognition.