Combining an Electrochemical Continuous Glucose Sensor With an Insulin Delivery Cannula: A Feasibility Study.

BACKGROUND: Combining a continuous glucose monitor with an insulin delivery cannula (CGM-IS) could benefit clinical outcomes. We evaluated the feasibility of a single-needle insertion electrochemical investigational CGM-IS (Pacific Diabetes Technologies, Portland, Oregon) in type 1 diabetes adults. METHODS: Following 48 hours run-in using a Medtronic 780G in manual mode with a commercial insulin set, 12 participants commenced insulin delivery using the CGM-IS. A standardized test meal was eaten on the mornings of days 1 and 4. Venous samples were collected every 10 minutes one hour prior to and 15 minutes post-meal for four hours. CGM-IS glucose measurements were post-processed with a single capillary blood calibration during warm-up and benchmarked against YSI. A Dexcom G6 sensor was worn post-consent to study end. RESULTS: Mean absolute relative difference (MARD) for the CGM-IS glucose measurements was 9.2% (484 paired data points). Consensus error grid revealed 88.6% within zone A and 100% in A + B. Mean (SD) % bias was -3.5 (11.7) %. There were 35 paired YSI readings <100 mg/dL cutoff and 449 ≥100 mg/dL with 81.4% within ±15 mg/dL or ±15%, and 89.9% within ±20 mg/dL or ±20%. Two cannula occlusions required discontinuation of insulin delivery: one at 70 hours post insertion and another during the day 4 meal test. Mean (SD) Dexcom glucose measurements during run-in and between meal tests was respectively 161.3 ± 27.3 mg/dL versus 158.0 ± 25.6 mg/dL; P = .39 and corresponding mean total daily insulin delivered by the pump was 58.0 ± 25.4 Units versus 57.1 ± 28.8 Units; P = .47. CONCLUSIONS: Insulin delivery and glucose sensing with the investigational CGM-IS was feasible. Longer duration studies are needed.

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.

Treatment satisfaction with Omnipod DASH in adults with type 1 diabetes: A non-blinded 1:1 randomized controlled trial.

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.

"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.

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.

Early childhood trauma and hippocampal volumes in patients with epileptic and psychogenic seizures.

OBJECTIVE: Exposure to early life childhood trauma has been implicated as resulting in a vulnerability to epileptic and psychogenic nonepileptic seizures (PNES), hippocampal atrophy, and psychiatric disorders. This study aimed to explore the relationships between childhood trauma, epilepsy, PNES, and hippocampal volume in patients admitted to a video-electroencephalogram monitoring (VEM) unit. METHODS: One hundred thirty-one patients were recruited from the Royal Melbourne Hospital VEM unit. The diagnostic breakdown of this group was: temporal lobe epilepsy (TLE) (32), other epilepsy syndromes (35), PNES (47), other nonepileptic syndromes (5), both epilepsy and PNES (6), and uncertain diagnosis (6). All patients completed a questionnaire assessing exposure to childhood trauma, the Childhood Trauma Questionnaire (CTQ), as well as questionnaires assessing psychiatric symptomatology (SCL-90-R), Anxiety and Depression (HADS), quality of life (QOLIE-98) and cognition (NUCOG). Volumetric coronal T1 MRI scans were available for 84 patients. Hippocampal volumes were manually traced by a blinded operator. RESULTS: The prevalence of childhood trauma in patients with PNES was higher than in patients with other diagnoses (p=0.005), and the group with PNES overall scored significantly higher on the CTQ (p=0.002). No association was found between CTQ scores and hippocampal volumes; however, patients with a history of sexual abuse were found to have smaller left hippocampal volumes than patients who had not (p=0.043). Patients reporting having experienced childhood trauma scored lower on measures of quality of life and higher on measures of psychiatric symptomatology. SIGNIFICANCE: Patients with PNES report having experienced significantly more childhood trauma than those with epileptic seizures, and in both groups there was a relationship between a history of having experienced sexual abuse and reduced left hippocampal volume. Patients with PNES and those with epilepsy who have a history of childhood trauma have overall worse quality of life and more psychiatric symptomatology.