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BackgroundA composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data.MethodsWe assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation.ResultsThe analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals.ConclusionThe GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Diabetic ketoacidosis (DKA) is a life‐threatening complication usually affecting people with type 1 diabetes (T1D) and, less commonly, people with type 2 diabetes. Early identification of ketosis is a cornerstone in DKA prevention and management. Current methods for ketone measurement by people with diabetes include capillary blood or urine testing. These approaches have limitations, including the need to carry testing strips that have a limited shelf life and a requirement for the user to initiate a test. Recent studies have shown the feasibility of continuous ketone monitoring (CKM) via interstitial fluid with a sensor inserted subcutaneously employing an enzymatic electrochemical reaction. Ketone readings can be updated every 5 minutes. In the future, one would expect that commercialized devices will incorporate alarms linked with standardized thresholds and trend arrows. Ideally, to minimize the burden on users, CKM functionality should be integrated with other devices used to implement glucose management, including continuous glucose monitors and insulin pumps. We suggest CKM provision to all at risk of DKA and recommend that the devices should be worn continuously. Those who may particularly benefit are individuals who have T1D, are pregnant, on medications such as sodium‐glucose linked transporter (SGLT) inhibitors that increase DKA, people with recurrent DKA, those with T1D undertaking high intensity exercise, are socially or geographically isolated, or those on low carbohydrate diets. The provision of ketone profiles will provide important clinical insights that have previously been unavailable to people living with diabetes and their healthcare professionals. Continuing Medical Education: Please visit https://health.learning.wiley.com/courses/dom-26s7 to complete an accredited learning activity for this article and receive 2.0 AMA PRA Category 1 Credit™. [ABSTRACT FROM AUTHOR]

Aims: In tackling rising diabetes‐related emergencies, the need to understand and address emergency service usage by people with type 1 diabetes is vital. This review aimed to quantify current trends in presentations for type 1 diabetes‐related emergencies and identify public health strategies that reduce the frequency of diabetes‐related emergencies and improve glycaemic management. Methods: Medline (OVID), Cochrane and CINAHL were searched for studies published between 2000 and 2023, focusing on people with type 1 diabetes, severe hypoglycaemia and/or diabetic ketoacidosis, and ambulance and/or emergency department usage. There were 1313 papers identified, with 37 publications meeting review criteria. Results: The incidence of type 1 diabetes‐related emergencies varied from 2.4 to 14.6% over one year for hypoglycaemic episodes, and between 0.07 and 11.8 events per 100 person‐years for hyperglycaemic episodes. Notably, our findings revealed that ongoing diabetes education and the integration of diabetes technology, such as continuous glucose monitoring and insulin pump therapy, significantly reduced the incidence of these emergencies. However, socio‐economic disparities posed barriers to accessing these technologies, subsequently shifting the cost to emergency healthcare and highlighting the need for governments to consider subsidising these technologies as part of preventative measures. Conclusions: Improving access to continuous glucose monitoring and insulin pump therapy, in combination with ongoing diabetes education focusing on symptom recognition and early management, will reduce the incidence of diabetes‐related emergencies. Concurrent research assessing emergency healthcare usage patterns during the implementation of such measures is essential to ensure these are cost‐effective. [ABSTRACT FROM AUTHOR]

Summary: 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [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]

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. [ABSTRACT FROM AUTHOR]