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"Bock, Martin"
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Open-Source Automated Insulin Delivery in Type 1 Diabetes
by
Burnside, Mercedes J.
,
Price, Sarah K.J.
,
Meier, Renee A.
in
Adolescent
,
Adolescent Medicine
,
Adult
2022
Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.
In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).
A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.
In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).
Journal Article
Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial
2022
BackgroundAutomated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes. MethodsWe present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers.Results59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n = 28) vs SAP + PLGM (n = 29) (30.9 ± 0.7 vs 27.9 ± 0.7, p = 0.004) and DTSQc AHCL (n = 29) vs SAP + PLGM (n = 30) (11.7 ± 0.9 vs 9.2 ± 0.8, p = 0.032). Adolescents (aged 13–17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 ± 0.7 vs 12.1 ± 0.8, p = 0.024). The DTQ “change” score (n = 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0, p < 0.001). PSQI was completed in those > 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3, p = 0.048) with a total score > 5 indicating poor quality sleep.ConclusionThese data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.
Journal Article
The effect of do‐it‐yourself real‐time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial
by
Elbalshy, Mona M.
,
Styles, Sara
,
Tomlinson, Paul
in
Blood Glucose
,
Blood Glucose Self-Monitoring
,
Child
2022
Background Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do‐it‐yourself real‐time continuous glucose monitoring (DIY RT‐CGM) on psychological and glycemic outcomes. Methods Child–parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT‐CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4‐week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures. Findings Fifty five child–parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, −0.1 (95%CI: −0.3, 0.1, p = 0.4), time‐in‐range (TIR) (%3.9‐10 mmol/L) was significantly higher with DIY RT‐CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT‐CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001). Conclusion The use of DIY RT‐CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT‐CGM appears safe and may offer families some clinically important advantages over isCGM.
Journal Article
Characterization of Orbital Angular Momentum Beams by Polar Mapping and Fourier Transform
2024
The recognition, decoding and tracking of vortex patterns is of increasing importance in many fields, ranging from the astronomical observations of distant galaxies to turbulence phenomena in liquids or gases. Currently, coherent light beams with orbital angular momentum (OAM) are of particular interest for optical communication, metrology, micro-machining or particle manipulation. One common task is to identify characteristic spiral patterns in pixelated intensity maps at real-world signal-to-noise ratios. A recently introduced combination of polar mapping and Fast Fourier Transform (FFT) was extended to novel sampling configurations and applied to the quantitative analysis of the spiral interference patterns of OAM beams. It is demonstrated that specific information on topological parameters in non-uniform arrays of OAM beams can be obtained from significantly distorted and noisy intensity maps by extracting one- or two-dimensional angular frequency spectra from single or concatenated circular cuts in either spatially fixed or scanning mode. The method also enables the evaluation of the quality of beam shaping and optical transmission. Results of proof-of-principle experiments are presented, resolution limits are discussed, and the potential for applications is addressed.
Journal Article
Needle beams: a review
2020
Needle beams are highly attractive for applications which take advantage from a spatial and temporal localization of photons. High intensities, high resolution and extended depth of focus lead to fundamental advances in the optical system performance. Ultrashort, fringe-free, self-reconstructing nondiffracting pulses with undistorted temporal transfer are obtained by generating truncated Bessel beams under self-apodization conditions. Nondiffracting Talbot self-imaging of needle beam arrays enables to transfer near field information to the Fraunhofer zone. With addressable arrays of needle beams, reconfigurable time-wavefront sensors are built up. Moreover, spatial light modulators and flexible axicons are used to realize structured, highly localized wavepackets, accelerating beams and nondiffracting images.
Journal Article
Impact of high‐risk glycemic control on habitual sleep patterns and sleep quality among youth (13–20 years) with type 1 diabetes mellitus compared to controls without diabetes
by
Smith, Claire
,
Wheeler, Benjamin J.
,
Boucher, Sara E.
in
Adolescent
,
Adult
,
Blood Glucose - metabolism
2021
Background In type 1 diabetes mellitus (T1D), glycemic control and sleep have a bidirectional relationship, with unhealthy glycemic control impacting sleep, and inadequate sleep impacting diabetes management. Youth are at risk for poor quality sleep; however, little is known about sleep among youth with high‐risk glycemic control. Objective To assess differences in habitual sleep timing, duration, and quality among youth with T1D and controls. Subjects Two‐hundred‐thirty youth (13–20 years): 64 with T1D (mean age 16.6 ± 2.1 years, 48% female, diabetes duration 7.5 ± 3.8 years, HbA1c 96 ± 18.0 mmol/mol [10.9 ± 1.7%]), and 166 controls (mean age 15.3 ± 1.5, 58% female). Methods Comparison of data from two concurrent studies (from the same community) using subjective and objective methods to assess sleep in youth: Pittsburgh Sleep Quality Index evaluating sleep timing and quality; 7‐day actigraphy measuring habitual sleep patterns. Regression analyses were used to compare groups. Results When adjusted for various confounding factors, youth with T1D reported later bedtimes (+36 min; p < 0.05) and shorter sleep duration (−53 min; p < 0.05) than controls, and were more likely to rate subjective sleep duration (OR 3.57; 95% CI 1.41–9.01), efficiency (OR 4.03; 95% CI 1.43–11.40), and quality (OR 2.59; 95% CI 1.16–5.76) as “poor” (p < 0.05). However, objectively measured sleep patterns were similar between the two groups. Conclusions Youth with high‐risk T1D experience sleep difficulties, with later bedtimes contributing to sleep deficit. Despite a lack of objective differences, they perceive their sleep quality to be worse than peers without diabetes.
Journal Article
Knowledge, safety, and impact of alcohol consumption in young adults with type 1 diabetes mellitus: a qualitative study
by
de Bock, Martin I
,
Sergel-Stringer, Oscar T
,
Styles, Sara E
in
Alcohol
,
Alcohol use
,
Dextrose
2023
Purpose
To explore the lived experiences of alcohol consumption among young adults with type 1 diabetes.
Methods
Fourteen semi-structured interviews were conducted amongst young adults aged between 18 and 25 years, inclusive, with type 1 diabetes and experience consuming alcohol. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences.
Results
The interviews confirmed that young adults with type 1 diabetes engage in social, and occasionally excessive, drinking behaviour. Furthermore, the interviews revealed four key themes: (i) Several sources contribute to a widely inconsistent understanding of the impact and management of alcohol consumption; (ii) Perceived inconvenience of maintaining healthy glycaemic control whilst drinking socially; (iii) Engagement in proactive strategies for harm reduction occurred when convenient; and (iv) Impact of modern diabetes technology in overcoming previous burdens and promoting glycaemic safety.
Conclusion
Young adults with type 1 diabetes continue to need anticipatory education surrounding safe alcohol consumption and behaviours, as well as ongoing support and encouragement to ensure engagement with traditional self-management tasks. Significant alcohol-diabetes related safety issues, particularly hypoglycaemia do occur, and were captured within this small sample and study. Diabetes technology has an important complementary role along with education and tailored support strategies to support health and safe glucose control during alcohol consumption.
Novelty Statement (bulleted)
Young adults with type 1 diabetes appear to consume alcohol at comparable rates to their counterparts without diabetes, but may experience a higher rate of harm.
Alcohol can result in significant harm (e.g., hypoglycaemia) in young adults with type 1 diabetes.
Current anticipatory education is inconsistent resulting in an increased exposure of some individuals to avoidable harms.
Safety-promoting behaviours can be implemented so long as they are minimally restrictive socially. Furthermore, advanced diabetes technologies potentially may offer a significant harm-reduction benefit to these young adults.
Journal Article
Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus
by
Tomlinson, Paul A.
,
Wheeler, Benjamin J.
,
Marsters, Brooke L.
in
Clinical trials
,
cutaneous adverse events
,
Diabetes
2020
Background The literature regarding flash glucose monitoring (FGM)‐associated cutaneous adverse events (AE) is limited. Objectives This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self‐monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss. Methods Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self‐reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss. Results Sixty‐four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE. Conclusions Cutaneous FGM‐associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.
Journal Article