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  1. 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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  2. Article ; Online: "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.

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

    Diabetes research and clinical practice

    2024  Volume 208, Page(s) 111123

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Adult ; Humans ; Female ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 1/psychology ; Hypoglycemic Agents/therapeutic use ; Australia ; Insulin/therapeutic use ; Injections ; Insulin Infusion Systems ; Blood Glucose
    Chemical Substances Hypoglycemic Agents ; Insulin ; Blood Glucose
    Language English
    Publishing date 2024-02-02
    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.2024.111123
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  3. Article ; Online: Improved Satisfaction While Maintaining Safety and High Time in Range (TIR) With a Medtronic Investigational Enhanced Advanced Hybrid Closed-Loop (e-AHCL) System.

    Yuan, Cheng Yi / Kong, Yee W / Amoore, Tess / Brown, Katrin / Grosman, Benyamin / Jenkins, Alicia / Jones, Hannah / Kurtz, Natalie / Lee, Melissa H / MacIsaac, Richard / Netzer, Emma / Paldus, Barbora / Robinson, Lesley / Roy, Anirban / Sims, Catriona M / Trawley, Steven / Vogrin, Sara / O'Neal, David N

    Diabetes care

    2024  Volume 47, Issue 4, Page(s) 747–755

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Adult ; Humans ; Female ; Blood Glucose ; Blood Glucose Self-Monitoring ; Diabetes Mellitus, Type 1/drug therapy ; Algorithms ; Insulin Infusion Systems ; Insulins ; Insulin/therapeutic use ; Hypoglycemic Agents/therapeutic use
    Chemical Substances Blood Glucose ; Insulins ; Insulin ; Hypoglycemic Agents
    Language English
    Publishing date 2024-02-21
    Publishing country United States
    Document type Clinical Trial ; Journal Article
    ZDB-ID 441231-x
    ISSN 1935-5548 ; 0149-5992
    ISSN (online) 1935-5548
    ISSN 0149-5992
    DOI 10.2337/dc23-2217
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  4. Article: A pilot randomised controlled parallel arm trial evaluating treatment satisfaction with the Omnipod DASH

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

    Pilot and feasibility studies

    2023  Volume 9, Issue 1, Page(s) 171

    Abstract: 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 ... ...

    Abstract 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
    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
    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.
    Language English
    Publishing date 2023-10-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2809935-7
    ISSN 2055-5784
    ISSN 2055-5784
    DOI 10.1186/s40814-023-01400-4
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  5. Article ; Online: Further delineation of Malan syndrome.

    Priolo, Manuela / Schanze, Denny / Tatton-Brown, Katrin / Mulder, Paul A / Tenorio, Jair / Kooblall, Kreepa / Acero, Inés Hernández / Alkuraya, Fowzan S / Arias, Pedro / Bernardini, Laura / Bijlsma, Emilia K / Cole, Trevor / Coubes, Christine / Dapia, Irene / Davies, Sally / Di Donato, Nataliya / Elcioglu, Nursel H / Fahrner, Jill A / Foster, Alison /
    González, Noelia García / Huber, Ilka / Iascone, Maria / Kaiser, Ann-Sophie / Kamath, Arveen / Liebelt, Jan / Lynch, Sally Ann / Maas, Saskia M / Mammì, Corrado / Mathijssen, Inge B / McKee, Shane / Menke, Leonie A / Mirzaa, Ghayda M / Montgomery, Tara / Neubauer, Dorothee / Neumann, Thomas E / Pintomalli, Letizia / Pisanti, Maria Antonietta / Plomp, Astrid S / Price, Sue / Salter, Claire / Santos-Simarro, Fernando / Sarda, Pierre / Segovia, Mabel / Shaw-Smith, Charles / Smithson, Sarah / Suri, Mohnish / Valdez, Rita Maria / Van Haeringen, Arie / Van Hagen, Johanna M / Zollino, Marcela / Lapunzina, Pablo / Thakker, Rajesh V / Zenker, Martin / Hennekam, Raoul C

    Human mutation

    2018  Volume 39, Issue 9, Page(s) 1226–1237

    Abstract: Malan syndrome is an overgrowth disorder described in a limited number of individuals. We aim to delineate the entity by studying a large group of affected individuals. We gathered data on 45 affected individuals with a molecularly confirmed diagnosis ... ...

    Abstract Malan syndrome is an overgrowth disorder described in a limited number of individuals. We aim to delineate the entity by studying a large group of affected individuals. We gathered data on 45 affected individuals with a molecularly confirmed diagnosis through an international collaboration and compared data to the 35 previously reported individuals. Results indicate that height is > 2 SDS in infancy and childhood but in only half of affected adults. Cardinal facial characteristics include long, triangular face, macrocephaly, prominent forehead, everted lower lip, and prominent chin. Intellectual disability is universally present, behaviorally anxiety is characteristic. Malan syndrome is caused by deletions or point mutations of NFIX clustered mostly in exon 2. There is no genotype-phenotype correlation except for an increased risk for epilepsy with 19p13.2 microdeletions. Variants arose de novo, except in one family in which mother was mosaic. Variants causing Malan and Marshall-Smith syndrome can be discerned by differences in the site of stop codon formation. We conclude that Malan syndrome has a well recognizable phenotype that usually can be discerned easily from Marshall-Smith syndrome but rarely there is some overlap. Differentiation from Sotos and Weaver syndrome can be made by clinical evaluation only.
    MeSH term(s) Abnormalities, Multiple/genetics ; Abnormalities, Multiple/physiopathology ; Adolescent ; Adult ; Bone Diseases, Developmental/genetics ; Bone Diseases, Developmental/physiopathology ; Child ; Child, Preschool ; Chromosome Deletion ; Congenital Hypothyroidism/genetics ; Congenital Hypothyroidism/physiopathology ; Craniofacial Abnormalities/genetics ; Craniofacial Abnormalities/physiopathology ; Developmental Disabilities/genetics ; Developmental Disabilities/physiopathology ; Exons/genetics ; Female ; Hand Deformities, Congenital/genetics ; Hand Deformities, Congenital/physiopathology ; Humans ; Intellectual Disability/genetics ; Intellectual Disability/physiopathology ; Male ; Megalencephaly/genetics ; Megalencephaly/physiopathology ; Mutation, Missense/genetics ; NFI Transcription Factors/genetics ; Phenotype ; Septo-Optic Dysplasia/genetics ; Septo-Optic Dysplasia/physiopathology ; Sotos Syndrome/genetics ; Sotos Syndrome/physiopathology ; Young Adult
    Chemical Substances NFI Transcription Factors ; NFIX protein, human
    Language English
    Publishing date 2018-06-25
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1126646-6
    ISSN 1098-1004 ; 1059-7794
    ISSN (online) 1098-1004
    ISSN 1059-7794
    DOI 10.1002/humu.23563
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