A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes.

OBJECTIVE: Qualitative meal-size estimation has been proposed instead of quantitative carbohydrate (CHO) counting with automated insulin delivery. We aimed to assess the noninferiority of qualitative meal-size estimation strategy. RESEARCH DESIGN AND METHODS: We conducted a two-center, randomized, crossover, noninferiority trial to compare 3 weeks of automated insulin delivery with 1) CHO counting and 2) qualitative meal-size estimation in adults with type 1 diabetes. Qualitative meal-size estimation categories were low, medium, high, or very high CHO and were defined as <30 g, 30-60 g, 60-90 g, and >90 g CHO, respectively. Prandial insulin boluses were calculated as the individualized insulin to CHO ratios multiplied by 15, 35, 65, and 95, respectively. Closed-loop algorithms were otherwise identical in the two arms. The primary outcome was time in range 3.9-10.0 mmol/L, with a predefined noninferiority margin of 4%. RESULTS: A total of 30 participants completed the study (n = 20 women; age 44 (SD 17) years; A1C 7.4% [0.7%]). The mean time in the 3.9-10.0 mmol/L range was 74.1% (10.0%) with CHO counting and 70.5% (11.2%) with qualitative meal-size estimation; mean difference was -3.6% (8.3%; noninferiority P = 0.78). Frequencies of times at <3.9 mmol/L and <3.0 mmol/L were low (<1.6% and <0.2%) in both arms. Automated basal insulin delivery was higher in the qualitative meal-size estimation arm (34.6 vs. 32.6 units/day; P = 0.003). CONCLUSIONS: Though the qualitative meal-size estimation method achieved a high time in range and low time in hypoglycemia, noninferiority was not confirmed.

A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System.

Aims: To assess the safety and efficacy of two exercise sessions performed 60- and 120-min postmeal with a combination of meal bolus reduction and increased glucose target to the automated insulin delivery (AID) system. Methods: A randomized crossover trial in 13 adult participants (6 females) living with type 1 diabetes using AID (A1c = 7.9% ± 0.6%, age = 53.5 ± 15.5 years, T1D duration = 29.0 ± 16.0 years) was conducted. Just before breakfast, at the time of meal bolus, the AID glucose target was increased from 6 to 9 mmol/L, and a meal bolus reduction of 33% was applied. Two 60-min exercise sessions (60% of VO2 peak) were undertaken either 60 min (60EX) or 120 min (120EX) after a standardized breakfast, followed by a 90-min recovery period. Results: The mean reduction in plasma glucose (PG) levels from prebreakfast to postexercise (-0.8 ± 2.4 mmol/L vs. +0.3 ± 2.3 mmol/L, P = 0.082) were similar between 60EX and 120EX. From prebreakfast to postexercise, PG times in range (3.9-10.0 mmol/L; 63.4% ± 43.1% 60EX vs. 51.9% ± 29.7% 120EX, P = 0.219) and time above range (>10.0 mmol/L; 36.3% ± 43.3% 60EX vs. 48.1% ± 29.7% 120EX, P = 0.211) did not differ between interventions. The 60EX attenuated the glucose rise between premeal to pre-exercise (+1.8 ± 2.1 mmol/L 60EX vs. +3.9 ± 2.1 mmol/L 120EX, P = 0.001). No hypoglycemic events (<3.9 mmol/L) occurred during the study. Conclusion: Premeal announcement combining meal bolus reduction and increased glucose target was effective and safe during 60 min of moderate-intensity aerobic exercise, whether exercise onset was 60 or 120 min following a meal. Clinical Trial Registration No.: NCT04031599.

Ketogenic Diet as a Normal Way of Eating in Adults With Type 1 and Type 2 Diabetes: A Qualitative Study.

OBJECTIVES: There are currently no recommendations on following the ketogenic diet (KD) in the context of diabetes and, therefore, health-care professionals may not be comfortable in supporting this dietary regimen. In this qualitative study, we aim to understand the perspective of patients with diabetes when following the KD, particularly with regard to reasons for starting the diet, motivators, support systems, sources of information and challenges. METHODS: Adults diagnosed with type 1 or type 2 diabetes who followed a KD for ≥3 months were recruited for inclusion in this study. Semistructured interviews were conducted, audio recorded and transcribed. Themes were analyzed using concept mapping until theme saturation was achieved. RESULTS: Participants were 54.5 (standard deviation 10.1) years old, on average, and had been following the KD for 6 to 19 (median 5) months; 43% were male and 79% had type 2 diabetes. The main motivation to start the diet was to improve blood glucose control or to reduce/stop taking diabetes medications, followed by weight loss and diabetes reversal. Participants reported benefits of the diet, such as improved glycemic control, weight loss and satiety, which appeared to strongly prevail over challenges, such as lack of support from health-care professionals and lack of information sources. Most participants considered the KD as a normalized way of eating that they would continue for the rest of their lives. CONCLUSIONS: A wide range of reported benefits, either expected or that emerged, strongly motivated individuals to follow the KD despite the lack of safety information and/or support. Further studies are needed to establish guidelines that health-care professionals can use to provide direction for individuals with diabetes who wish to follow the KD.

Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial.

Objective: Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared with sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform. Research Design and Methods: We conducted a two-center, randomized crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9-10.0 mmol/L. Results: The automated insulin delivery system was operational 90.2% of the time. Compared with the sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (interquartile range 53-74) to 69% (60-73; P = 0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30-49) to 45% (35-51; P = 0.011). Automated insulin delivery also reduced time spent below 3.9 and 3.3 mmol/L from 3.5% (0.8-5.4) to 1.6% (1.1-2.7; P = 0.0021) and from 0.9% (0.2-2.1) to 0.5% (0.2-1.1; P = 0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0-0.6) with sensor-augmented pump therapy and 0.1% (0.0-0.4; P = 0.155) with automated insulin delivery. Conclusions: Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy. ClinicalTrials.gov no. NCT02846831.

Artificial Pancreas Systems and Physical Activity in Patients with Type 1 Diabetes: Challenges, Adopted Approaches, and Future Perspectives.

Physical activity is important for patients living with type 1 diabetes (T1D) but limited by the challenges associated with physical activity induced glucose variability. Optimizing glycemic control without increasing the risk of hypoglycemia is still a hurdle despite many advances in insulin formulations, delivery methods, and continuous glucose monitoring systems. In this respect, the artificial pancreas (AP) system is a promising therapeutic option for a safer practice of physical activity in the context of T1D. It is important that healthcare professionals as well as patients acquire the necessary knowledge about how the AP system works, its limits, and how glucose control is regulated during physical activity. This review aims to examine the current state of knowledge on exercise-related glucose variations especially hypoglycemic risk in T1D and to discuss their effects on the use and development of AP systems. Though effective and highly promising, these systems warrant further research for an optimized use around exercise.

Single Injection of High Volume of Autologous Pure PRP Provides a Significant Improvement in Knee Osteoarthritis: A Prospective Routine Care Study.

BACKGROUND: Evidence is growing regarding the ability of platelet-rich plasma (PRP) injections to enhance functional capacity and alleviate pain in knee osteoarthritis (OA). However, heterogeneity in common practice regarding PRP preparation and biological content makes the initiation of this activity in a hospital complex. The aim of this study was to document the efficacy of a single PRP injection to treat knee OA and validate a routine care procedure. METHODS: Fifty-seven patients with symptomatic knee OA received a single injection of large volume of very pure PRP. They were assessed at baseline and after one, three and six months, by measuring Knee Injury and Osteoarthritis Score (KOOS), Observed Pain after a 50-foot walk test and Visual Analog Scale (VAS) assessments. Magnetic Resonance Imaging (MRI) analysis was performed at baseline and six months after the procedure. The objective was to recover 50% of responders three months after the procedure using OMERACT-OARSI criteria. RESULTS: A single administration of high volume pure PRP provided significant clinical benefit for 84.2% of the responders, three months after the procedure. The KOOS total score significantly increased from 43.5 ± 14.3 to 66.4 ± 21.7 six months after the procedure (p < 0.001). Pain also significantly decreased from 37.5 ± 25.1 to 12.9 ± 20.9 (p < 0.001). No difference was observed on MRI parameters. CONCLUSION: A single injection of large volume of very pure PRP is associated with significant functional improvement and pain relief, allowing initiation of daily PRP injection within our hospital.

Managing pain and anxiety during transabdominal chorionic villus sampling. A noninferiority randomized trial of nitrous oxide vs local anesthesia.

INTRODUCTION: Transabdominal chorionic villus sampling (CVS) is an invasive procedure for prenatal diagnosis reported to be associated with anxiety and pain. In this context, the need for analgesia during CVS has been considered useful. Even though several authors have been interested in pain management during amniocentesis, no study has been published on pain reduction during CVS. Our objective was to evaluate pain and anxiety management during transabdominal CVS using nitrous oxide (N2 O) and local anesthesia. MATERIAL AND METHODS: In a randomized controlled noninferiority trial, self-administered nitrous oxide (N2 O) inhalation (equimolar premix of oxygen and nitrous oxide) was compared with local anesthesia (1% lidocaine) before CVS. Primary outcome was pain and secondary outcome was anxiety, both measured on a visual analog scale 30-60 minutes before, immediately after (5-10 minutes) and 30-60 minutes after CVS. With a statistical power of 90%, type I error of 5% and two-sided test and potential exclusions, a sample size of 96 patients per group was enrolled and randomized. No patient was enrolled before the trial registration date. RESULTS: From 13 March 2013 through 10 February 2015, 192 patients (96 per group) were screened and randomized. Most characteristics were similar across groups. Pain in the N2 O group was 2.65 ± 0.22 vs 3.32 ± 0.26 in local anesthesia group [mean ± standard error of mean  (SEM)]. Mean anxiety in the N2 O group was 3.17 ± 0.27 vs 5.19 ± 0.30 in the local anesthesia group. CONCLUSION: N2 O was as efficient and even superior to local anesthesia for both pain and anxiety reduction during CVS, as the 95% confidence intervals were both below the prespecified noninferiority margin of 0.8 and below zero.

Global and public health core competencies for nursing education: A systematic review of essential competencies.

OBJECTIVES: Nurses are learning and practicing in an increasingly global world. Both nursing schools and nursing students are seeking guidance as they integrate global health into their learning and teaching. This systematic review is intended to identify the most common global and public health core competencies found in the literature and better inform schools of nursing wishing to include global health content in their curricula. DESIGN: Systematic review. DATA SOURCES: An online search of CINAHL and Medline databases, as well as, inclusion of pertinent gray literature was conducted for articles published before 2013. REVIEW METHODS: Relevant literature for global health (GH) and public and community health (PH/CH) competencies was reviewed to determine recommendations of both competencies using a combination of search terms. Studies must have addressed competencies as defined in the literature and must have been pertinent to GH or PH/CH. The databases were systematically searched and after reading the full content of the included studies, key concepts were extracted and synthesized. RESULTS AND CONCLUSION: Twenty-five studies were identified and resulted in a list of 14 global health core competencies. These competencies are applicable to a variety of health disciplines, but particularly can inform the efforts of nursing schools to integrate global health concepts into their curricula.

Barriers and facilitators to preparing families with premature infants for discharge home from the neonatal unit. Perceptions of health care providers.

OBJECTIVE: To explore Colombian health care provider perceptions of barriers and facilitators to preparing families with premature infants for discharge home from the neonatal intensive care unit (NICU). METHODOLOGY: Using a qualitative descriptive design, in-depth semi-structured interviews were conducted with fifteen neonatal health care providers (HCPs) in Colombia. Data were analyzed using qualitative content analysis. RESULTS: Participant responses centered on three main themes: 1) establishment of the parent-infant bond, 2) acquisition of parenting skills, and 3) getting ready for the transition from hospital to home. Barreirs to preparing parents for NICU discharge included obstacles to parental visiting in the NICU, communication barriers, difficulties related to the establishment of successful breastfeeding, insufficient human resources and poor links between hospital and community-based resources. Facilitators included the availability of social aids for vulnerable families, 24-hour telephone access to the neonatal units, tailored educational materials and group sessions, continuing education for staff and the community-based Kangaroo Program available to parents post-discharge. Adolescent mothers, indigenous parent and working fathers were identified as particularly challenging to reach and engage in discharge preparation. CONCLUSION: Neonatal HCPs identified numerous challenges as well as helpful strategies for preparing families for hospital discharge. Additional studies are needed on the experience of neonatal discharge from the perspective of parents of premature infants in Colombia, to help inform optimal interventions for supporting families during the transition from hospital to home.

Barreras y facilitadores para las familias con bebés prematuros que se preparan para el alta de la unidad neonatal. Percepciones del personal de salud / Barreiras e facilitadores para as famílias com bebês prematuros que se preparam para a alta da unidade neonatal. Percepções do pessoal de saúde / Barriers and facilitators to preparing families with premature infants for discharge home from the neonatal unit. Perceptions of health care providers

Explorar las percepciones del personal de salud neonatal sobre las barreras y facilitadores para las familias con bebés prematuros que se preparan para el alta de la Unidad de Cuidado Intensivo Neonatal –UCIN-. Metodología. Utilizando un diseño cualitativo descriptivo, se realizaron entrevistas semi-estructuradas a profundidad a 15 profesionales de la salud neonatal en Colombia. Los datos fueron analizados mediante el análisis de contenido. Resultados. Las respuestas de los participantes se centraron en tres temas principales: 1) el establecimiento del vínculo entre padres y el niño, 2) la adquisición de habilidades parentales, y 3) preparación para la transición del hospital al hogar. Las barreras para la preparación de los padres para el egreso del niño, incluyen desde los obstáculos a los padres para la visita en la UCIN, las barreras de comunicación, las dificultades relacionadas con el establecimiento de la lactancia materna exitosa, los recursos insuficientes de personal de salud y escasos vínculos entre el hospital y la comunidad. Los facilitadores fueron la disponibilidad de ayudas sociales para las familias vulnerables, el acceso telefónico de 24 horas a las unidades neonatales, los materiales educativos adaptados, la educación continua para el personal de salud, y la disponibilidad para los padres del Programa Canguro de base comunitaria después del alta. Las madres adolescentes, los padres que trabajan y la familia indígena fueron grupos identificados como particularmente difíciles para que participaran en la preparación del alta. Conclusión. El personal de salud identificó numerosos desafíos, así como estrategias útiles para la preparación de las familias para el alta hospitalaria del prematuro...

Objective. To explore Colombian health care provider perceptions of barriers and facilitators to preparing families with premature infants for discharge home from the neonatal intensive care unit (NICU). Methodology. Using a qualitative descriptive design, in-depth semi-structured interviews were conducted with fifteen neonatal health care providers (HCPs) in Colombia. Data were analyzed using qualitative content analysis. Results. Participant responses centered on three main themes: 1) establishment of the parent-infant bond, 2) acquisition of parenting skills, and 3) getting ready for the transition from hospital to home. Barreirs to preparing parents for NICU discharge included obstacles to parental visiting in the NICU, communication barriers, difficulties related to the establishment of successful breastfeeding, insufficient human resources and poor links between hospital and community-based resources. Facilitators included the availability of social aids for vulnerable families, 24-hour telephone access to the neonatal units, tailored educational materials and group sessions, continuing education for staff and the community-based Kangaroo Program available to parents post-discharge. Adolescent mothers, indigenous parent and working fathers were identified as particularly challenging to reach and engage in discharge preparation. Conclusion. Neonatal HCPs identified numerous challenges as well as helpful strategies for preparing families for hospital discharge. Additional studies are needed on the experience of neonatal discharge from the perspective of parents of premature infants in Colombia, to help inform optimal interventions for supporting families during the transition from hospital to home...

Objetivo. Explorar as percepções do pessoal de saúde neonatal sobre as barreiras e facilitadores para as famílias com bebês prematuros que se preparam para a alta da Unidade de Cuidado Intensivo Neonatal –UCIN-. Metodologia. Utilizando um desenho qualitativo descritivo, realizaram-se entrevistas semiestruturadas a profundidade a 15 profissionais da saúde neonatal na Colômbia. Os dados foram analisados mediante a análise de conteúdo. Resultados. As respostas dos participantes se centraram em três temas principais: 1) o estabelecimento do vínculo entre pais e o menino, 2) a aquisição de habilidades parentais, e 3) preparação para a transição do hospital ao lar. As barreiras para a preparação dos pais para a saída da criança, incluem desde os obstáculos aos pais para a visita na UCIN, as barreiras de comunicação, as dificuldades relacionadas com o estabelecimento da lactância materna exitosa, os recursos insuficientes de pessoal de saúde e escassos vínculos entre o hospital e a comunidade. Os facilitadores foram a disponibilidade de ajudas sociais para as famílias vulneráveis, o acesso telefônico de 24 horas às unidades neonatais, os materiais educativos adaptados, a educação contínua para o pessoal de saúde, e a disponibilidade para os pais do Programa Canguru de base comunitária depois da alta. As mães adolescentes, os pais que trabalham e a família indígena foram grupos identificados como particularmente difíceis para que participassem na preparação da alta. Conclusão. O pessoal de saúde identificou numerosos desafios, bem como estratégias úteis para a preparação das famílias para a alta hospitalar do prematuro. Precisam-se estudos adicionais na experiência da alta neonatal desde a perspectiva dos pais de bebês prematuros na Colômbia, para ajudar a documentar as intervenções ótimas para apoiar às famílias durante a transição do hospital ao lar...