17 research outputs found

    AiDAPT: Automated insulin Delivery Amongst Pregnant women with Type 1 diabetes:A multicentre randomized controlled trial – study protocol

    No full text
    BACKGROUND: Pregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications. Despite using diabetes technologies including continuous glucose monitoring (CGM), insulin pumps and contemporary insulin analogues, most women struggle to achieve and maintain the recommended pregnancy glucose targets. This study aims to evaluate whether the use of automated closed-loop insulin delivery improves antenatal glucose levels in pregnant women with type 1 diabetes.METHODS/DESIGN: A multicentre, open label, randomized, controlled trial of pregnant women with type 1 diabetes and a HbA1c of ≥48 mmol/mol (6.5%) at pregnancy confirmation and ≤ 86 mmol/mol (10%) at randomization. Participants who provide written informed consent before 13 weeks 6 days gestation will be entered into a run-in phase to collect 96 h (24 h overnight) of CGM glucose values. Eligible participants will be randomized on a 1:1 basis to CGM (Dexcom G6) with usual insulin delivery (control) or closed-loop (intervention). The closed-loop system includes a model predictive control algorithm (CamAPS FX application), hosted on an android smartphone that communicates wirelessly with the insulin pump (Dana Diabecare RS) and CGM transmitter. Research visits and device training will be provided virtually or face-to-face in conjunction with 4-weekly antenatal clinic visits where possible. Randomization will stratify for clinic site. One hundred twenty-four participants will be recruited. This takes into account 10% attrition and 10% who experience miscarriage or pregnancy loss. Analyses will be performed according to intention to treat. The primary analysis will evaluate the change in the time spent in the target glucose range (3.5-7.8 mmol/l) between the intervention and control group from 16 weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (&gt; 7.8 mmol/l), standard CGM metrics, HbA1c and psychosocial functioning and health economic measures. Safety outcomes include the number and severity of ketoacidosis, severe hypoglycaemia and adverse device events.DISCUSSION: This will be the largest randomized controlled trial to evaluate the impact of closed-loop insulin delivery during type 1 diabetes pregnancy.TRIAL REGISTRATION: ISRCTN 56898625 Registration Date: 10 April, 2018.</p

    Automated insulin delivery during the first 6 months postpartum (AiDAPT): A prespecified extension study

    No full text
    Background: Clinical guidelines in the UK and elsewhere do not specifically address hybrid closed loop (HCL) use in the postpartum period when the demands of caring for a newborn are paramount. Our aim was to evaluate the safety and efficacy of HCL use during the first 6 months postpartum compared with standard care. Methods: In this prespecified extension to a multicentre, randomised controlled trial, pregnant women with type 1 diabetes at nine UK sites were followed up for 6 months postpartum. Eligible participants (AiDAPT participants recruited after the implementation of the postpartum protocol amendment approval, those still pregnant or within six months of delivery at the time of amendment implementation and still using HCL or continuous glucose monitoring [CGM] therapy) continued their randomly assigned treatment, either standard insulin therapy with CGM or HCL therapy (CamAPS FX system version 0.3.1, CamDiab, Cambridge, UK). Participants were randomised in a 1:1 ratio with stratification by clinical site using randomly permuted block sizes of 2 or 4. The primary outcome was the between-group difference in percentage time in range ([TIR] 3·9–10·0 mmol/L [70–180mg/dL]), measured during the periods of month 0 up to 3, months 3 to 6, and over 6 months postpartum. The study is registered at ClinicalTrials.gov (ISRCTN56898625) and is complete. Findings: Of the 124 AiDAPT trial participants, 66 (53%) were ineligible for inclusion in the postpartum extension, and 57 participants consented to continue their treatment per original random allocation. The mean age was 31 years (SD 4), and all participants had early pregnancy HbA1c 59·4 mmol/mol (SD 10·5 [7·6% SD 1·0%]). In the 6 months postpartum, mean time with glucose levels within the target range was higher in the HCL group compared with the standard care group (72% [SD 12%] vs 54% [17%]), with an adjusted treatment difference of 15% (95% CI 7 to 22). Results for hyperglycaemia (>10·0 mmol/L) and mean CGM glucose also favoured HCL (–14% [95% CI –23% to –6%] and –1·3 mmol/L [–2·3 to –0·3], respectively). Hypoglycaemia rates were low, with no between-group differences (2·4% vs 2·6%). There were no treatment effect changes depending on postpartum period (0 up to 3 months vs 3 to 6 months) and no unanticipated safety problems. Interpretation: Participants in the HCL group maintained 70% TIR during the first 6 months postpartum, supporting continued use of HCL rather than standard insulin therapy for people with diabetes once they have given birth

    A study of diabetic ketoacidosis in the pregnant population in the United Kingdom. Investigating the incidence, aetiology, management and outcomes

    No full text
    © 2021 The Authors. Published by Wiley. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1111/dme.14743Aim To estimate the incidence of diabetic ketoacidosis (DKA) among pregnant women, describe its clinical features, management and outcomes and identify the risk factors for the condition. Methods A national population-based case–control study was conducted in the UK using the UK Obstetric Surveillance System between April 2019 and September 2020 including all pregnant women with DKA irrespective of the level of blood glucose. The incidence rate of DKA in pregnancy was estimated. A case–control analysis limited to women with type 1 diabetes was performed comparing characteristics of women with DKA (cases) to those of women whose pregnancies were not complicated by DKA (controls). Results In all, 82 women were identified with DKA in pregnancy; 6.3 per 100,000 maternities (95% CI: 5.0–7.9). No maternal deaths occurred, but perinatal mortality was 12/73 (16%) with 11 stillbirths and one neonatal death. DKA episodes mostly occurred in women with type 1 diabetes (85%) and in the 3rd trimester of pregnancy (71%). Episodes were mainly precipitated by infection (21%), vomiting (21%), steroid therapy (13%) and medication errors (10%). Fifteen percent of women had more than one episode of DKA during their pregnancy. Risk factors associated with DKA among women with type 1 diabetes identified through the case–control analysis were the woman and/or partner not being in a paid employment and having at least one microvascular complication of diabetes before pregnancy. Conclusion DKA in pregnancy was associated with high perinatal mortality and was linked with factors related to socio-economic deprivation, mental health problems and long-term difficulties with glycaemic control.National Institute for Health Research. Grant Number: PB-PG-0817–20004Published versio

    Carbon Emissions and Economic Growth: Production-based versus Consumption-based Evidence on Decoupling

    No full text
    We assess the Carbon-Kuznets-Curve hypothesis using internationally consistent and comparable production-based versus consumption-based CO2 emissions data for 40 countries(and 35 industries) during 1995-2007 from the World Input Output Database (WIOD). Theestimates for per capita CO2 emissions are truly comprehensive as these include all carbonemissions embodied in international trade and global commodity chains. Even if we findevidence suggesting a decoupling of production-based CO2 emissions and growth, consumptionbasedCO2 emissions are monotonically increasing with per capita GDP. We draw out the implications of these findings for climate policy and binding emission reduction obligations

    Uncertainties in adoption of model-based definition and enterprise for high-value manufacturing

    No full text
    Incorrect spelling of the author name in the paper: should be Ahmed Al-Ashaab.The world is adopting digital technologies at a rapid pace which are the key enablers to improve every walk of life in the modern era. This quest for digitization has equal rigor within the manufacturing industry. 2D drawings have been used historically to define the specifications of a product for manufacturing. The evolution in digital technologies has made it possible to improve the way of representing these specifications in the form of 3D models which is known as Model-Based Definition (MBD). However, the 2D representation is still the authoritative source within the industry for engineering definition and related documents in the product lifecycle. Though MBD has been adopted in design, discrete part manufacturing, and inspection stages to some extent, the industry heavily relies on the conventional 2D representation of product definition. The digitization process of product definition lies within the adoption of MBD as the authoritative source for all the enterprise activities which is referred to as Modelbased Enterprise (MBE). However, there are several uncertainties and risks in this process. In this work, it is ascertained to formulate the key uncertainties in the transformation towards MBD/E. These uncertainties are categorized and analyzed further for visualization.18th International Conference on Manufacturing Research, incorporating the 35th National Conference on Manufacturing Researc

    Evaluation of surface water quality and heavy metal indices of Ismailia Canal, Nile River, Egypt

    No full text
    Ismailia Canal is one of the most important branches of the Nile River in Egypt. It is the main source of drinking and irrigation water for many cities. Weighted arithmetic method of water quality index (WQI) was used to evaluate the water quality of Ismailia Canal according to drinking, irrigation and aquatic life water utilizations. The objective of the index is to transform complex water quality data into understandable and usable information by the public. The WQI values of Ismailia Canal are good to poor for drinking and aquatic life utilizations, and excellent for irrigation utilization. Metal index (MI) and pollution index (PI) were calculated to assess the contaminations of the canal water with the metals (Al+3, Cd+2. Cu+2, Fe+2, Mn+2, Ni+2, Pb+2 and Zn+2). MI and PI values denote the dangerous pollution of the canal water, which is described as seriously at most sites along, in particular for drinking and fisheries utilizations. It may be attributed to the effluents of different industrial wastes arriving at the canal water. Law 48/1982 for the protection of the Nile River and its waterways against pollution must be enforced to prevent the obvious deterioration of the canal water and to improve its quality

    Removal of aluminum, iron and manganese ions from industrial wastes using granular activated carbon and Amberlite IR-120H

    No full text
    AbstractThe removal of aluminum, iron and manganese from some pollution sources that drain into Ismailia Canal has been investigated using two different sorbents; granular activated carbon (GAC) and Amberlite IR-120H (AIR-120H). Batch equilibrium experiments showed that the two sorbents have maximum removal efficiency for aluminum and iron pH 5 and 10min contact time in ambient room temperature, while pH 7 and 30min were the most appropriate for manganese removal. Dosage of 2g/l for both GAC and AIR-120H was established to give the maximum removal capacity. At optimum conditions, the removal trend was in order of Al+3>Fe+2>Mn+2 with 99.2, 99.02 and 79.05 and 99.55, 99.42 and 96.65% of metal removal with GAC and AIR-120H, respectively. For the three metals, Langmuir and Freundlich isotherms showed higher R2 values, with a slightly better fitting for the Langmuir model. In addition, separation factors (RL) and exponent (n) values indicated favorable Langmuir (0<RL<1) and Freundlich (1<n<10) approach. GAC and AIR-120H can be used as excellent alternative, effective and inexpensive materials to remove high amounts of heavy metals from waste water
    corecore