1,721,108 research outputs found
Design and Usability Assessment of a User-Centered, Modular Platform for Real-World Data Acquisition in Clinical Trials involving Post-bariatric Surgery Patients
No full textBackground: Clinical trials often face challenges in efficient data collection and participant monitoring. To address these issues, we developed the IMPACT platform, comprising a real-time mobile application for data collection and a web-based dashboard for remote monitoring and management. Methods: This article presents the design, development, and usability assessment of the IMPACT platform customized for patients with post-bariatric surgery hypoglycemia (PBH). We focus on adapting key IMPACT components, including continuous glucose monitoring (CGM), symptom tracking, and meal logging, as crucial elements for user-friendly and efficient PBH monitoring. Results: The adapted IMPACT platform demonstrated effectiveness in data collection and remote participant monitoring. The mobile application allowed patients to easily track their data, while the clinician dashboard provided a comprehensive overview of enrolled patients, featuring filtering options and alert mechanisms for identifying data collection issues. The platform incorporated various visual representations, including time plots and category-based visualizations, which greatly facilitated data interpretation and analysis. The System Usability Scale questionnaire results indicated a high level of usability for the web dashboard, with an average score of 86.3 out of 100. The active involvement of clinicians throughout the development process ensured that the platform allowed for the collection and visualization of clinically meaningful data. Conclusions: By leveraging IMPACT's existing features and infrastructure, the adapted version streamlined data collection, analysis, and trial customization for PBH research. The platform's high usability underscores its alignment with the requirements for conducting research using continuous real-world data in PBH patients and other populations of interest
[Formula diets for weight loss - chances and challenges].
No full textFormula diets, through the use of industrially manufactured meal replacement products, lead to effective and rapid weight reduction and improvement in obesity-associated comorbidities. The specific composition of these meal replacement products simplifies the adherence to calorie goals and ensures the supply of essential nutrients during significant energy restriction. Despite numerous potential applications, evidence from randomized controlled studies, and simplicity in practical implementation, challenges persist. Monotony and social restrictions complicate adherence and acceptance. The use of formula diets for sustainable weight loss requires integration into a multimodal treatment approach with the goal of long-term changes in eating and activity behaviour. This includes accompanying nutritional counselling, promotion of physical activity, evaluation of adjuvant pharmacological or interventional therapies, as well as psychological support. The development of new incretin-based anti-obesity medications has opened another application field for formula products. There is optimization potential in expanding the product range and combining it with digital applications to enhance acceptance and reach a larger patient group
Forecasting postbariatric hypoglycaemia in Roux-en-Y gastric bypass patients using model-based algorithms fed by continuous glucose monitoring data: a proof-of-concept study.
Full text link1020-P: A New Ambulatory Glucose Profile Report to Evaluate and Support Glucose Control in People after Bariatric Surgery
No full text1569-P: Quantification of Postprandial Hepatic Glucose Disposal in Roux-en-Y Gastric Bypass and Non-operated Controls Using Stable Isotope Labelling and Liver Metabolic Imaging
No full text
Study protocol for a randomised, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on postprandial hypoglycaemia after gastric bypass.
Full text linkINTRODUCTION
Postprandial hypoglycaemia after gastric bypass surgery (also known as postbariatric hypoglycaemia or PBH) is an increasingly encountered clinical problem. PBH is characterised by meal-induced rapid spikes and consequent falls in glycaemia, resulting in both hypoglycaemia burden and high glycaemic variability. Despite its frequency, there is currently no approved pharmacotherapy. The purpose of this investigation is to evaluate efficacy and safety of empagliflozin 25 mg, a sodium-glucose cotransporter 2-inhibitor, to reduce glucose excursions and hypoglycaemia burden in patients with PBH after gastric bypass surgery.
METHODS AND ANALYSIS
In a prospective, single-centre, randomised, double-blind, placebo-controlled, crossover trial, we plan to enrol 22 adults (≥18 years) with PBH after Roux-en-Y gastric bypass surgery (plasma or sensor glucose <3.0 mmol/L). Eligible patients will be randomised to receive empagliflozin 25 mg and placebo once daily, each for 20 days, in random order. Study periods will be separated by a 2-6 weeks wash-out period. The primary efficacy outcome will be the amplitude of plasma glucose excursion (peak to nadir) during a mixed meal tolerance test. Results will be presented as paired-differences±SD plus 95% CIs with p values and hypothesis testing for primary and secondary outcomes according to intention-to-treat. Secondary outcomes include continuous glucose monitoring-based outcomes, further metabolic measures and safety.
ETHICS AND DISSEMINATION
The DEEP-EMPA trial (original protocol title: Randomized, double-blind, placebo-controlled crossover trialassessing the impact of the SGLT2 inhibitor empagliflozin onpostprandial hypoglycaemia after gastric bypass) was approved by the Bern Ethics Committee (ID 2021-01187) and Swissmedic (Ref. Number: 102663190) in October and November 2021, respectively. First results are expected in the first quarter of 2023 and will be disseminated via peer-reviewed publications and presented at national and international conferences. The acronym DEEP was derived from an overarching project title (DEciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia after Bariatric Surgery), the term EMPA stands for the drug empagliflozin.
TRIAL REGISTRATION NUMBER
NCT05057819
Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System During Cardiac Surgery Using Hypothermic Extracorporeal Circulation.
No full textBACKGROUND
Continuous glucose monitoring (CGM) may be challenged by extreme conditions during cardiac surgery using hypothermic extracorporeal circulation (ECC).
RESEARCH DESIGN AND METHODS
We evaluated the Dexcom G6 sensor in 16 subjects undergoing cardiac surgery with hypothermic ECC, of whom 11 received deep hypothermic circulatory arrest (DHCA). Arterial blood glucose, quantified by the Accu-Chek Inform II meter, served as reference.
RESULTS
Intrasurgery mean absolute relative difference (MARD) of 256 paired CGM/reference values was 23.8%. MARD was 29.1% during ECC (154 pairs) and 41.6% immediately after DHCA (10 pairs), with a negative bias (signed relative difference: -13.7%, -26.6%, and -41.6%). During surgery, 86.3% pairs were in Clarke error grid zones A or B and 41.0% of sensor readings fulfilled the International Organization for Standardization (ISO) 15197:2013 norm. Postsurgery, MARD was 15.0%.
CONCLUSIONS
Cardiac surgery using hypothermic ECC challenges the accuracy of the Dexcom G6 CGM although recovery appears to occur thereafter
Relationship Between Symptom Perception and Postprandial Glycemic Profiles in Patients With Postbariatric Hypoglycemia After Roux-en-Y Gastric Bypass Surgery.
No full textOBJECTIVE
Post-bariatric surgery hypoglycemia (PBH) is a metabolic complication of Roux-en-Y gastric bypass (RYGB). Since symptoms are a key component of the Whipple's triad to diagnose nondiabetic hypoglycemia, we evaluated the relationship between self-reported symptoms and postprandial sensor glucose profiles.
RESEARCH DESIGN AND METHODS
Thirty patients with PBH after RYGB (age: 50.1 [41.6-60.6] years, 86.7% female, BMI: 26.5 [23.5-31.2] kg/m2; median [interquartile range]) wore a blinded Dexcom G6 sensor while recording autonomic, neuroglycopenic, and gastrointestinal symptoms over 50 days. Symptoms (overall and each type) were categorized into those occurring in postprandial periods (PPPs) without hypoglycemia, or in the preceding dynamic or hypoglycemic phase of PPPs with hypoglycemia (nadir sensor glucose <3.9 mmol/L). We further explored the relationship between symptoms and the maximum negative rate of sensor glucose change and nadir sensor glucose levels.
RESULTS
In 5,851 PPPs, 775 symptoms were reported, of which 30.6 (0.0-59.9)% were perceived in PPPs without hypoglycemia, 16.7 (0.0-30.1)% in the preceding dynamic phase and 45.0 (13.7-84.7)% in the hypoglycemic phase of PPPs with hypoglycemia. Per symptom type, 53.6 (23.8-100.0)% of the autonomic, 30.0 (5.6-80.0)% of the neuroglycopenic, and 10.4 (0.0-50.0)% of the gastrointestinal symptoms occurred in the hypoglycemic phase of PPPs with hypoglycemia. Both faster glucose dynamics and lower nadir sensor glucose levels were related with symptom perception.
CONCLUSIONS
The relationship between symptom perception and PBH is complex, challenging clinical judgement and decision-making in this population
Exercise-associated glucose metabolism in individuals with type 1 diabetes mellitus.
Full text linkPURPOSE OF REVIEW
The primary focus of this review is threefold: first, to summarize available knowledge on exercise-associated glucose metabolism in individuals with type 1 diabetes mellitus (T1DM); second, to elucidate physiological mechanisms predisposing to glycemic variations in patients in T1DM; and third, to describe novel approaches derived from physiological perceptions applicable to stabilize exercise-related glycemia in individuals with T1DM.
RECENT FINDINGS
Recent studies corroborate the concept that despite partial differences in counter-regulatory mechanisms individuals with T1DM do not fundamentally differ in their glucose response to exercise when compared with healthy individuals if studies are performed under standardized conditions with insulin and glucose levels held close to physiological ranges. Novel approaches derived from a better understanding of exercise-associated glucose metabolism (e.g., the concept of intermittent high-intensity exercise) may provide alternative ways to master the challenges imposed by exercise to individuals with T1DM.
SUMMARY
Exercise still imposes high demands on patients with T1DM and increases risks for hypoglycemia and hyperglycemia. Deeper insight into the associated metabolic pathways has revealed novel options to stabilize exercise-associated glucose levels in these patients
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