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

Lee, Melissa H / Vogrin, Sara / Jones, Timothy W / O'Neal, David N

Journal of diabetes science and technology

2024 , Page(s) 19322968241231307

Abstract: 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 ... ...

Abstract	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], 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.
Language	English
Publishing date	2024-02-19
Publishing country	United States
Document type	Journal Article
ISSN	1932-2968
ISSN (online)	1932-2968
DOI	10.1177/19322968241231307
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Article ; Online: Exercising Safely with the MiniMed™ 780G Automated Insulin Delivery System.

O'Neal, David N / Zaharieva, Dessi P / Morrison, Dale / McCarthy, Olivia / Nørgaard, Kirsten

Diabetes technology & therapeutics

2024 Volume 26, Issue S3, Page(s) 84–96

Abstract: The physical and psychological benefits of exercise are particularly pertinent to people with type 1 diabetes (T1D). The variability in subcutaneous insulin absorption and the delay in offset and onset in glucose lowering action impose limitations, given ...

Abstract	The physical and psychological benefits of exercise are particularly pertinent to people with type 1 diabetes (T1D). The variability in subcutaneous insulin absorption and the delay in offset and onset in glucose lowering action impose limitations, given the rapidly varying insulin requirements with exercise. Simultaneously, there are challenges to glucose monitoring. Consequently, those with T1D are less likely to exercise because of concerns regarding glucose instability. While glucose control with exercise can be enhanced using automated insulin delivery (AID), all commercially available AID systems remain limited by the pharmacokinetics of subcutaneous insulin delivery. Although glycemic responses may vary with exercises of differing intensities and durations, the principles providing the foundation for guidelines include minimization of insulin on board before exercise commencement, judicious and timely carbohydrate supplementation, and when possible, a reduction in insulin delivered in anticipation of planned exercise. There is an increasing body of evidence in support of superior glucose control with AID over manual insulin dosing in people in T1D who wish to exercise. The MiniMed™ 780G AID system varies basal insulin delivery with superimposed automated correction boluses. It incorporates a temporary (elevated glucose) target of 8.3 mmol/L (150 mg/dL) and when it is functioning, the autocorrection boluses are stopped. As the device has recently become commercially available, there are limited data assessing glucose control with the MiniMed™ 780G under exercise conditions. Importantly, when exercise was planned and implemented within consensus guidelines, %time in range and %time below range targets were met. A practical approach to exercising with the device is provided with illustrative case studies. While there are limitations to spontaneity imposed on any AID device due to the pharmacokinetics associated with the subcutaneous delivery of current insulin formulations, the MiniMed™ 780G system provides people with T1D an excellent option for exercising safely if the appropriate strategies are implemented.
MeSH term(s)	Humans ; Insulin/therapeutic use ; Diabetes Mellitus, Type 1/drug therapy ; Hypoglycemic Agents/therapeutic use ; Blood Glucose ; Blood Glucose Self-Monitoring ; Insulin Infusion Systems ; Insulin, Regular, Human/therapeutic use
Chemical Substances	Insulin ; Hypoglycemic Agents ; Blood Glucose ; Insulin, Regular, Human
Language	English
Publishing date	2024-02-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2023.0420
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Zs.A 5269: Show issues

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Article ; Online: Outcomes associated with a variable rate insulin infusion diabetic ketoacidosis protocol.

Koneshamoorthy, Anojian / Epa, Dilan Seneviratne / O'Neal, David N / Lee, Melissa H / Santamaria, John D / MacIsaac, Richard J

Journal of diabetes and its complications

2024 Volume 38, Issue 3, Page(s) 108702

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Diabetes Mellitus ; Diabetic Ketoacidosis/drug therapy ; Diabetic Ketoacidosis/epidemiology ; Hyperglycemia/prevention & control ; Hypoglycemia/chemically induced ; Hypoglycemia/prevention & control ; Hypokalemia/chemically induced ; Hypokalemia/epidemiology ; Insulin/adverse effects ; Insulin, Regular, Human ; Potassium ; Retrospective Studies
Chemical Substances	Insulin ; Insulin, Regular, Human ; Potassium (RWP5GA015D)
Language	English
Publishing date	2024-02-15
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2024.108702
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Article ; Online: An Assessment of Clinical Continuous Glucose Monitoring Targets for Older and High-Risk People Living with Type 1 Diabetes.

O'Neal, David N / Cohen, Ohad / Vogrin, Sara / Vigersky, Robert A / Jenkins, Alicia J

Diabetes technology & therapeutics

2022 Volume 25, Issue 2, Page(s) 108–115

Abstract: Aim: ...

Abstract	Aim:
MeSH term(s)	Adult ; Humans ; Aged ; Diabetes Mellitus, Type 1/drug therapy ; Blood Glucose ; Hypoglycemic Agents/therapeutic use ; Blood Glucose Self-Monitoring ; Insulin/therapeutic use
Chemical Substances	Blood Glucose ; Hypoglycemic Agents ; Insulin
Language	English
Publishing date	2022-12-13
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1452816-2
ISSN	1557-8593 ; 1520-9156
ISSN (online)	1557-8593
ISSN	1520-9156
DOI	10.1089/dia.2022.0350
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Article: Practical Aspects and Exercise Safety Benefits of Automated Insulin Delivery Systems in Type 1 Diabetes.

Zaharieva, Dessi P / Morrison, Dale / Paldus, Barbora / Lal, Rayhan A / Buckingham, Bruce A / O'Neal, David N

Diabetes spectrum : a publication of the American Diabetes Association

2023 Volume 36, Issue 2, Page(s) 127–136

Abstract: Regular exercise is essential to overall cardiovascular health and well-being in people with type 1 diabetes, but exercise can also lead to increased glycemic disturbances. Automated insulin delivery (AID) technology has been shown to modestly improve ... ...

Abstract	Regular exercise is essential to overall cardiovascular health and well-being in people with type 1 diabetes, but exercise can also lead to increased glycemic disturbances. Automated insulin delivery (AID) technology has been shown to modestly improve glycemic time in range (TIR) in adults with type 1 diabetes and significantly improve TIR in youth with type 1 diabetes. Available AID systems still require some user-initiated changes to the settings and, in some cases, significant pre-planning for exercise. Many exercise recommendations for type 1 diabetes were developed initially for people using multiple daily insulin injections or insulin pump therapy. This article highlights recommendations and practical strategies for using AID around exercise in type 1 diabetes.
Language	English
Publishing date	2023-05-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2211544-4
ISSN	1040-9165
ISSN	1040-9165
DOI	10.2337/dsi22-0018
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Article ; Online: Mitochondrial DNA copy number in adults with and without Type 1 diabetes.

Jenkins, Alicia J / Carroll, Luke M / Huang, Michael L H / Wen-Loh, Yik / Mangani, Abubakar / O'Neal, David N / Januszewski, Andrzej S

Diabetes research and clinical practice

2023 Volume 203, Page(s) 110877

Abstract: Aims: Mitochondrial damage is implicated in diabetes pathogenesis and complications. Mitochondrial DNA copy number (mtDNA-cn) in human Type 1 diabetes (T1D) studies are lacking. We related mtDNA-cn in T1D and non-diabetic adults (CON) with diabetes ... ...

Abstract	Aims: Mitochondrial damage is implicated in diabetes pathogenesis and complications. Mitochondrial DNA copy number (mtDNA-cn) in human Type 1 diabetes (T1D) studies are lacking. We related mtDNA-cn in T1D and non-diabetic adults (CON) with diabetes complications and risk factors. Methods: Cross-sectional study: 178 T1D, 132 non-diabetic controls. Associations of whole blood mtDNA-cn (qPCR) with complications, inflammation, and C-peptide. Results: mtDNA-cn (median (LQ, UQ)) was lower in: T1D vs. CON (271 (189, 348) vs. 320 (264, 410); p < 0.0001); T1D with vs. without kidney disease (238 (180, 309) vs. 294 (198, 364); p = 0.02); and insulin injection vs. pump-users (251 (180, 340) vs. 322 (263, 406); p = 0.008). Significant univariate correlates of mtDNA-cn: T1D: (positive) HDL-C; (negative) fasting glucose, white cell count (WCC), sVCAM-1, sICAM-1; CON: (negative) WHR (waist-hip-ratio). Detectable C-peptide in T1D increased with lowest-highest mtDNA-cn tertiles (54%, 69%, 79%, p = 0.02). Independent determinants of mtDNA-cn: T1D: (positive) HDL-C; (negative) age, sICAM-1; AUROC 0.71; CON: WCC (negative), never smoking, (positive) female, pulse pressure; AUROC 0.74. Conclusions: mtDNA-cn is lower in T1D vs. CON, and in T1D kidney disease. In T1D, mtDNA-cn correlates inversely with age and inflammation, and positively with HDL-C, detectable C-peptide and pump use. Further clinical and basic science studies are merited.
Language	English
Publishing date	2023-08-12
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	632523-3
ISSN	1872-8227 ; 0168-8227
ISSN (online)	1872-8227
ISSN	0168-8227
DOI	10.1016/j.diabres.2023.110877
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Article ; Online: Increased intracellular miR-142 in adults with Type 1 diabetes.

Huang, Li / Januszewski, Andrzej S / Takahashi, Yusuke / O'Neal, David N / Ma, Jian-Xing / Jenkins, Alicia J

Journal of diabetes and its complications

2023 Volume 37, Issue 10, Page(s) 108597

Abstract: microRNAs (miRs), including miR-142, modulate gene expression and processes implicated in vascular damage and may serve as therapeutic targets and agents, including in Type 1 diabetes (T1D). The project aimed to assess whether miR-142 levels differ ... ...

Abstract	microRNAs (miRs), including miR-142, modulate gene expression and processes implicated in vascular damage and may serve as therapeutic targets and agents, including in Type 1 diabetes (T1D). The project aimed to assess whether miR-142 levels differ between people with and without T1D, and to analyse miR-142 associations with cardiovascular (CVD) risk factors. Intracellular miRs were isolated from whole blood cell pellets using TRIzol-based methodology. In a cross-sectional study in 102 adults cellular miR-142 levels were significantly higher (on unadjusted and adjusted analyses) in 69 adults with T1D relative to 33 non-diabetic subjects: mean ± SD, 3.53 ± 3.66 vs. 1.25 ± 0.78, p < 0.0002, but were not related to HbA1c levels. Further miR-142 research, including longitudinal and intervention studies and basic science are of interest. miR-142 may be valuable in clinical practice for predicting health and as a treatment target.
Language	English
Publishing date	2023-08-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2023.108597
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Article ; Online: What difference does sleep make? Continuous glucose monitoring metrics during fixed-overnight time versus sleep periods among older adults with type 1 diabetes.

Trawley, Steven / Kubilay, Erin / Colman, Peter G / Lee, Melissa H / O'Neal, David N / Sundararajan, Vijaya / Vogrin, Sara / McAuley, Sybil A

Journal of sleep research

2023 , Page(s) e14106

Abstract: 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 ... ...

Abstract	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.
Language	English
Publishing date	2023-12-05
Publishing country	England
Document type	Journal Article
ZDB-ID	1122722-9
ISSN	1365-2869 ; 0962-1105
ISSN (online)	1365-2869
ISSN	0962-1105
DOI	10.1111/jsr.14106
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Zs.A 3464: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Treatment satisfaction with Omnipod DASH in adults with type 1 diabetes: A non-blinded 1:1 randomized controlled trial.

Kong, Yee Wen / Yuan, Cheng Yi / Kiburg, Katerina / Brown, Katrin / Trawley, Steven / Partovi, Andi / Roem, Kerryn / Pham, Cecilia / Harrison, Natalie / Fourlanos, Spiros / Ekinci, Elif I / O'Neal, David N

The Journal of clinical endocrinology and metabolism

2024

Abstract: Objective: We compared treatment satisfaction with a tubeless insulin pump (Omnipod DASH® Insulin Management System) to usual care (multiple daily injections [MDI] or tubed insulin pump therapy [IPT]) in adults with type 1 diabetes using self-monitoring ...

Abstract	Objective: We compared treatment satisfaction with a tubeless insulin pump (Omnipod DASH® Insulin Management System) to usual care (multiple daily injections [MDI] or tubed insulin pump therapy [IPT]) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG). Research design and methods: Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from four diabetes centers in Australia were randomized in a 1:1 non-blinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension where 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, glycemic and device-related outcomes at 12-weeks (study-end) and 24-weeks (end-extension). Results: Treatment satisfaction improved more in Omnipod group vs. Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs. 0.0 [12.8]; p < 0.001) at study-end. Significantly greater improvements in other PROs and HbA1c were also observed. Improvements in DTQ-current and other PROs comparing study-end and end-extension were similar. While %TIR 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 = 0.016). Conclusions: Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG which was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed.
Language	English
Publishing date	2024-02-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	3029-6
ISSN	1945-7197 ; 0021-972X
ISSN (online)	1945-7197
ISSN	0021-972X
DOI	10.1210/clinem/dgae088
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Article ; Online: Interactive calculator to estimate insulin sensitivity in type 1 diabetes.

Januszewski, Andrzej S / Niedzwiecki, Pawel / Sachithanandan, Nirupa / Ward, Glenn M / O'Neal, David N / Zozulinska-Ziolkiewicz, Dorota A / Uruska, Aleksandra A / Jenkins, Alicia J

Journal of diabetes investigation

2024 Volume 15, Issue 5, Page(s) 594–597

Abstract: The gold standard for measuring insulin sensitivity (IS) is the hyperinsulinemic-euglycemic clamp, a time, costly, and labor-intensive research tool. A low insulin sensitivity is associated with a complication-risk in type 1 diabetes. Various formulae ... ...

Abstract	The gold standard for measuring insulin sensitivity (IS) is the hyperinsulinemic-euglycemic clamp, a time, costly, and labor-intensive research tool. A low insulin sensitivity is associated with a complication-risk in type 1 diabetes. Various formulae using clinical data have been developed and correlated with measured IS in type 1 diabetes. We consolidated multiple formulae into an online calculator (bit.ly/estimated-GDR), enabling comparison of IS and its probability of IS <4.45 mg/kg/min (low) or >6.50 mg/kg/min (high), as measured in a validation set of clamps in 104 adults with type 1 diabetes. Insulin sensitivity calculations using different formulae varied significantly, with correlations (R
MeSH term(s)	Humans ; Diabetes Mellitus, Type 1/blood ; Insulin Resistance ; Female ; Adult ; Glucose Clamp Technique ; Male ; Blood Glucose/analysis ; Middle Aged ; Insulin
Chemical Substances	Blood Glucose ; Insulin
Language	English
Publishing date	2024-02-17
Publishing country	Japan
Document type	Journal Article
ZDB-ID	2625840-7
ISSN	2040-1124 ; 2040-1116
ISSN (online)	2040-1124
ISSN	2040-1116
DOI	10.1111/jdi.14161
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