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.

Insulin antibodies are prevalent in adults with type 1 diabetes referred for islet cell transplantation and are modified by islet transplantation and immunosuppression: an Australian experience.

We have analysed insulin antibodies in 149 adults with type 1 diabetes and 2859 people without diabetes. We have determined that insulin antibody levels are higher in adults with, versus without, diabetes and that the levels are falling, and more patients are becoming antibody-negative post islet cell transplantation.

Diabetic ketoacidosis in adult patients: an audit of factors influencing time to normalisation of metabolic parameters.

BACKGROUND: Diabetic ketoacidosis (DKA) is an acute life-threatening metabolic complication of diabetes that imposes substantial burden on our healthcare system. There is a paucity of published data in Australia assessing factors influencing time to resolution of DKA and length of stay (LOS). AIMS: To identify factors that predict a slower time to resolution of DKA in adults with diabetes. METHODS: Retrospective audit of patients admitted to St Vincent's Hospital Melbourne between 2010 to 2014 coded with a diagnosis of 'Diabetic Ketoacidosis'. The primary outcome was time to resolution of DKA based on normalisation of biochemical markers. Episodes of DKA within the wider Victorian hospital network were also explored. RESULTS: Seventy-one patients met biochemical criteria for DKA; median age 31 years (26-45 years), 59% were male and 23% had newly diagnosed diabetes. Insulin omission was the most common precipitant (42%). Median time to resolution of DKA was 11 h (6.5-16.5 h). Individual factors associated with slower resolution of DKA were lower admission pH (P < 0.001) and higher admission serum potassium level (P = 0.03). Median LOS was 3 days (2-5 days), compared to a Victorian state-wide LOS of 2 days. Higher comorbidity scores were associated with longer LOS (P < 0.001). CONCLUSIONS: Lower admission pH levels and higher admission serum potassium levels are independent predictors of slower time to resolution of DKA. This may assist to stratify patients with DKA using markers of severity to determine who may benefit from closer monitoring and to predict LOS.

Aceruloplasminaemia: a disorder of diabetes and neurodegeneration.

Aceruloplasminaemia is an autosomal recessive disorder of iron metabolism which is characterised by diabetes, neurodegeneration and anaemia. It should be considered in the differential diagnosis of adult onset, antibody-negative diabetes associated with persistent mild anaemia and hyperferritinaemia and/or progressive neuropsychiatric impairments.

Factors associated with duration of inpatient hospital stay for patients with diabetes mellitus admitted to a medical unit in a community public hospital.

The aim was to examine predictors of duration of inpatient hospital stay in people with diabetes mellitus to assist implementation of strategies to reduce hospital stay. This audit prospectively studied patients with diabetes mellitus admitted to a medical unit of an Australian community public hospital. Other outcome measures included glucose treatment optimisation and access to GP and diabetes-specific healthcare professionals. Comparison was made to patients without diabetes mellitus who were admitted concomitantly. Diabetes patients represented 26% of admissions over a 2-month period. In total, 73% had seen a GP within the prior 6 months. Patients with diabetes mellitus (n=79) had a median age of 69 years; 53% were male and median HbA1c was 65mmolmol-1 (8.1%). Diabetes mellitus was associated with a longer inpatient stay (P=0.03), particularly among patients admitted with vascular disease. Age >65 years and seeing <3 members of the community-based diabetes mellitus multidisciplinary team (MDT) in the 2-years pre-admission were independently associated with a longer stay (P=0.02). In total, 10% were referred to an endocrinologist on discharge. Involvement of more of the diabetes-specific MDT, with a skilled GP, in primary care is recommended as it may shorten inpatient hospital stay, improve glycaemia and reduce demand for limited specialist endocrinologists.

Hybrid Closed-Loop Versus Manual Insulin Delivery in Adults With Type 1 Diabetes: A Post Hoc Analysis Using the Glycemia Risk Index.

BACKGROUND: Glycemia risk index (GRI) is a novel composite metric assessing overall glycemic risk, accounting for both hypoglycemia and hyperglycemia and weighted toward extremes. Data assessing GRI as an outcome measure in closed-loop studies and its relation with conventional key continuous glucose monitoring (CGM) metrics are limited. METHODS: A post hoc analysis was performed to evaluate the sensitivity of GRI in assessing glycemic quality in adults with type 1 diabetes randomized to 26 weeks hybrid closed-loop (HCL) or manual insulin delivery (control). The primary outcome was GRI comparing HCL with control. Comparisons were made with changes in other CGM metrics including time in range (TIR), time above range (TAR), time below range (TBR), and glycemic variability (standard deviation [SD] and coefficient of variation [CV]). RESULTS: GRI with HCL (N = 61) compared with control (N = 59) was significantly lower (mean [SD] 33.5 [11.7] vs 56.1 [14.4], respectively; mean difference -22.8 [-27.2, -18.3], P = .001). The mean increase in TIR was +14.8 (11.0, 18.5)%. GRI negatively correlated with TIR for combined arms (r = -.954; P = .001), and positively with TAR >250 mg/dL (r = .901; P = .001), TBR < 54 mg/dL (r = .416; P = .001), and glycemic variability (SD [r = .916] and CV [r = .732]; P = .001 for both). CONCLUSIONS: Twenty-six weeks of HCL improved GRI, in addition to other CGM metrics, compared with standard insulin therapy. The improvement in GRI was proportionally greater than the change in TIR, and GRI correlated with all CGM metrics. We suggest that GRI may be an appropriate primary outcome for closed-loop trials.

Outcomes associated with a variable rate insulin infusion diabetic ketoacidosis protocol.

AIMS: To relate adverse events with glucose correction rates in diabetic ketoacidosis (DKA) using variable rate intravenous insulin-infusions (VRIII). METHODS: Retrospective, observational study in adults with DKA who received insulin infusions between 2012 and 2017 at St Vincent's Hospital, Melbourne. Early correction of hyperglycaemia (<10 mmol/L) was evaluated for association with hypoglycaemia (<4.0 mmol/L), hypokalaemia (potassium <3.3 mmol/L) and clinical outcomes via regression analysis. RESULTS: The study involved 97 patients, with 93 % having type 1 diabetes. The mean age was 38 years, 47 % were women and 35 % were admitted to intensive care. Hypoglycaemia rates during 12 and 24 h of treatment were 6.2 % and 8.2 %, respectively with 58 % of patients recording their first BGL <10 mmol/L within 12 h and 88 % within 24 h. Ketone clearance time averaged at 15.6 h. Hyperglycaemia correction rates to <10 mmol/L were not different in those with/without hypoglycaemia at 12/24 h, in multivariate analysis including admission BGL. Hypokalaemia occurred in 40.2 % of patients and was associated with lower pH but not BGL correction rates. CONCLUSION: The VRIII protocol achieved early hyperglycaemia correction and ketoacidosis reversal with low hypoglycaemia risk. However, high hypokalaemia rates suggest the need for aggressive potassium replacement, especially in markedly acidotic patients.

Hybrid Closed Loop in Adults With Type 1 Diabetes and Severely Impaired Hypoglycemia Awareness.

BACKGROUND: Benefits of hybrid closed-loop (HCL) systems in a high-risk group with type 1 diabetes and impaired awareness of hypoglycemia (IAH) have not been well-explored. METHODS: Adults with Edmonton HYPO scores ≥1047 were randomized to 26-weeks HCL (MiniMed™ 670G) vs standard therapy (multiple daily injections or insulin pump) without continuous glucose monitoring (CGM) (control). Primary outcome was percentage CGM time-in-range (TIR; 70-180 mg/dL) at 23 to 26 weeks post-randomization. Major secondary endpoints included magnitude of change in counter-regulatory hormones and autonomic symptom responses to hypoglycemia at 26-weeks post-randomization. A post hoc analysis evaluated glycemia risk index (GRI) comparing HCL with control groups at 26 weeks post-randomization. RESULTS: Nine participants (median [interquartile range (IQR)] age 51 [41, 59] years; 44% male; enrolment HYPO score 1183 [1058, 1308]; Clarke score 6 [6, 6]; n = 5 [HCL]; n = 4 [control]) completed the study. Time-in-range was higher using HCL vs control (70% [68, 74%] vs 48% [44, 50%], P = .014). Time <70 mg/dL did not differ (HCL 3.8% [2.7, 3.9] vs control 6.5% [4.3, 8.6], P = .14) although hypoglycemia episode duration was shorter (30 vs 50 minutes, P < .001) with HCL. Glycemia risk index was lower with HCL vs control (38.1 [30.0, 39.2] vs 70.8 [58.5, 72.4], P = .014). Following 6 months of HCL use, greater dopamine (24.0 [12.3, 27.6] vs -18.5 [-36.5, -4.8], P = .014), and growth hormone (6.3 [4.6, 16.8] vs 0.5 [-0.8, 3.0], P = .050) responses to hypoglycemia were observed. CONCLUSIONS: Six months of HCL use in high-risk adults with severe IAH increased glucose TIR and improved GRI without increased hypoglycemia, and partially restored counter-regulatory responses. CLINICAL TRIAL REGISTRATION: ACTRN12617000520336.

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.

Functional outcome after air-stirrup ankle brace or fiberglass backslab for pediatric low-risk ankle fractures: a randomized observer-blinded controlled trial.

OBJECTIVES: Pediatric ankle fractures are usually treated by immobilization with either a posterior splint, cast, or ankle brace. We set out to determine if the below-knee fiberglass posterior splint was as effective as the Air-Stirrup ankle brace in returning children with a low risk ankle fracture to their normal level of activity. METHODS: This was a randomized, single-blinded, noninferiority, controlled trial at the Royal Children's Hospital, Melbourne. Children aged 5 to 15 years presenting acutely with a low-risk ankle fracture were randomized to the Air-Stirrup ankle brace or fiberglass posterior splint. A validated self-reported outcome tool, the Activities Scale for Kids performance (ASKp), was used to measure physical functioning over the 4 week period. Main outcome was ASKp scores at 2 and 4 weeks with secondary outcomes including pain, weight-bearing ability, and acceptability of device. RESULTS: Forty-five patients were randomized: 23 in the posterior splint group and 22 in the Air-Stirrup ankle brace. Study groups were similar in terms of age, fracture type, and baseline pain. More of the posterior splint group were non-weight bearing "at enrollment" (96%) compared with the ankle brace group (77%). The median ASKp score at 4 weeks was 91.9 in the brace group and 84.2 in the posterior splint group. Scores on the ASKp as well as ASKp differences were favorable toward the brace in the 11- to 15-year age group at 2 weeks (69.6 vs 55.6) and 4 weeks (97.5 vs 90.2) but trended toward the posterior splint in the 5- to 10-year age group (47.5 vs 56). CONCLUSIONS: There was no difference between the Air-Stirrup ankle brace and the fiberglass posterior splint in returning children to their normal levels of activity.

Comparable Glucose Control with Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System During Exercise.

Background: This study compared glucose control with fast-acting insulin aspart (FiAsp) versus insulin aspart following moderate-intensity exercise (MIE) and high-intensity exercise (HIE) using a second-generation closed-loop (CL) system in people with type 1 diabetes. Materials and Methods: This randomized crossover study compared FiAsp versus insulin aspart over four sessions during MIE and HIE with CL insulin delivery by the MiniMed™ Advanced hybrid CL system. Participants were randomly assigned FiAsp and insulin aspart each for 6 weeks and within each period performed, in random order, 40 min MIE (∼50% VO2max) and HIE (6 × 2 min ∼80% VO2max; 5 min recovery). The primary outcome was continuous glucose monitoring (CGM) time in range (TIR, 3.9-10.0 mM) for 24 h following exercise. Results: Sixteen adults (9 male; age 48 [37, 57] years; hemoglobin A1c (HbA1c) 7.0 [6.4, 7.2] %; duration diabetes 30 [17, 41] years) were recruited. In the 24 h postexercise, median TIR was >81%, time in hypoglycemia (<3.9 mM) was <4%, and time in hyperglycemia (>10 mM) was <17% for both exercise conditions and insulin formations, with no significant differences between insulins (P > 0.05). In the 2 h postexercise and overnight, the TIR approached 100% for all conditions. Conclusions: There were no differences in TIR during and 24 h after MIE or HIE when comparing insulin aspart with FiAsp delivered by a second-generation CL system. Insulin formulations with an offset in action greater than FiAsp are needed to provide a meaningful improvement in CL glucose control with exercise. Clinical Trial Registration number: ACTRN12619000469112.

Upload and Review of Insulin Pump and Glucose Sensor Data by Adults with Type 1 Diabetes: A Clinic Audit.

Devices have facilitated improvement in glycemia in individuals with type 1 diabetes mellitus (T1DM), but self-management remains key. It is unclear whether people review their device data before clinic appointment. We assessed this by a survey. T1DM adults using glucose sensors and/or insulin pumps attending an Australian public hospital (diabetes clinics >4 months) were prospectively surveyed. The percentage who uploaded and reviewed their data was determined and their interest in education facilitating understanding of their device data was assessed. Of 138 adults (100% participation rate), 79% uploaded and 32% reviewed their device data before their clinic appointments. Individuals using pumps with sensors were most likely to review their data. Median HbA1c levels were lower in those who did versus did not review their device data (50.8 vs. 61.8 mmol/mol, P = 0.0001). Most (89%) were interested in education. Although diabetes technology has improved glycemia in T1DM, the benefits may be maximized through device-specific education programs enhancing self-management.

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.

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.

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.