A call for a multidisciplinary approach to improving treatment of in-hospital non-severe hypoglycemia for people living with diabetes.

Type 1 Diabetes in Children and Adolescents.

Aims/hypothesisConsumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions.MethodsTwenty-four adults with insulin pump-treated type 1 diabetes (HbA1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods. During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively. Glycaemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event registration of prevention and treatment episodes.ResultsCompared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9–10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (−0.7, 5.5) and −0.5 %-points (−1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (−18, −3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia.Conclusions/interpretationUse of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.Trial registrationClinicalTrials.gov NCT04764968FundingThe study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial.Graphical abstract

Introducción: la hipoglucemia es un efecto adverso común del tratamiento de la diabetes y se considera el mayor factor limitante para alcanzar los objetivos. Abordar los eventos de hipoglucemia es muy importante tanto en el consultorio como en investigación.Objetivos: caracterizar a la población en términos de edad, sexo, tipo de diabetes, tiempo de evolución, HbA1c, tratamiento y prevalencia de hipoglucemia no severa (nivel 1 y nivel 2) en el último mes y severa (nivel 3) en los últimos tres meses. Evaluar desencadenantes de hipoglucemia. Evaluar conducta ante la hipoglucemia no severa y severa, el conocimiento reportado de las personas de su entorno y las fuentes de educación diabetológica. Evaluar la sensación de miedo frente a la hipoglucemia y su asociación con eventos de hipoglucemia.Materiales y métodos: estudio observacional, multicéntrico, de corte transversal, realizado desde mayo a julio de 2020 en el Capítulo Comahue de la SAD. Se encuestaron aleatoriamente pacientes con diabetes mayores de 18 años. Criterios de exclusión: pacientes que no puedan responder el interrogatorio, embarazadas, que no cuenten con método de medición de glucosa.

Background: For nonsevere hypoglycemia (NS-H), treatment guidelines recommend 15-20g of rapidly absorbed carbohydrates (CHO) and repeat intake at 15 min until recovery (glucose above 70 mg/dL). The adequacy of this one size fits all approach is questioned. Our group reported an average intake of 32 ± 24g CHO in a type 1 diabetes (T1D) outpatient study. We aim to validate N-SH treatment guidelines in the context of modern therapies. Methods: Randomized four way cross-over trial to assess treatment with 16g vs. 32 g CHO (glucose tablets) for fasting subcutaneous insulin induced NS-H at two glucose thresholds: a) below 54 mg/dL and b) between 54 to 63 mg/dL. Plasma glucose is measured every 5 min till recovery then at 15-30 min intervals. Results: Preliminary data was collected for 12 of 33 subjects (53.2 ± 16.8 years old, 58.3% females, HbA1c 56 ± 7.7 mmol/mol, diabetes duration 31.9 ± 15.8 years). Comparison of 16 vs. 32g CHO for each threshold revealed the following change in glucose 15 min post treatment (primary outcome): a) below 54 mg/dL: 12.0 ± 21.8 vs. 17.6± 28.4 mg/dL, p=0.4; b) between 54 to 63 mg/dL: -1.6 ± 19.7 vs. 12 ± 22.7 mg/dL, p=0.06; time needed to recovery (above70 mg/dL): a) below 54 mg/dL: 30 ± 13.6 vs. 29.6 ±14.4 min, p= 0.9; b) between 54 to 63 mg/dL: 37.5 ±14.4 vs. 28.7 ± 17.2 min, p= 0.1 and time needed for disappearance of symptoms: a) below 54 mg/dL: 27.8± 22.3 vs. 22.8 ± 9.5 min, p=0.8; b) between 54 to 63 mg/dL: 24.2 ± 10.7 vs. 16.7± 11.5 min, p=0.5. Regression analysis will be conducted to study response predictors (plasma insulin and catecholamines levels, body composition, etc.) Conclusion: The response to nonsevere hypoglycemia treatment is extremely variable. A one size fits all recommendation is unlikely to be appropriate. Data of this trial will add to the knowledge of hypoglycemia treatment in T1D. Disclosure N. Taleb: None. V. Messier: Other Relationship; Self; Eli Lilly and Company. V. Parent: None. D. Bovan: None. A. Brazeau: None. R. Rabasa-Lhoret: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk A/S. Funding Canadian Institutes of Health Research (354024); JDRF (4-SRA-2018-651-Q-R)

Objective: To evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia in people with type 1 diabetes during free-living conditions. Methods: Twenty-four adults with insulin pump-treated type 1 diabetes completed a phase 2, randomized, open-label, 2-period cross-over study with 2-week periods. During the usual care (UC) and dasiglucagon (DASI) period, participants managed impending and manifest episodes of hypoglycemia with regular carbohydrate consumption or pen-administered low-dose (80 µg) s.c. dasiglucagon, respectively. Glycemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event-registration of prevention and treatment episodes. Patient-reported outcomes (PRO) were collected following study completion. Results: Participants administered dasiglucagon (IQR: 7-15) times during the 2-week period. Compared with UC, the mean difference (±SEM) in time in range (70-180 mg/dL) was 2.4%-point (±1.5%) (UC: 61.5%, DASI: 63.9%, p=0.129) , difference in time below range (&amp;lt;70 mg/dL) was 0.5%-point (±0.4%) (UC: 3.1%, DASI: 2.6%, p=0.170) , while total daily carbohydrate intake was significantly reduced (UC: 192 g, DASI: 172 g, p=0.007) . Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8, p=0.206) . PRO demonstrated that 96% (p&amp;lt;0.001) of participants were likely to include dasiglucagon as part of their future routine management of hypoglycemia. Conclusion: Utilization of pen-administered, low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia during free-living conditions was safe and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction. Disclosure C.Laugesen: None. A.G.Ranjan: None. S.Schmidt: None. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk A/S, Consultant; Novo Nordisk A/S, Research Support; Dexcom, Inc., Medtronic, Novo Nordisk A/S, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Stock/Shareholder; Novo Nordisk A/S. Funding SteDiabetes Center Copenhagen is the sponsor of this investigator-initiated trial. Zealand Pharma provided financial support to the conduct of the study and supplied the study medication.

To determine the views of nurses and physicians working in intensive care units (ICU) about the aims of glycaemic control and use of their protocols. Evidence about the optimal aims and methods for glycaemic control in ICU is controversial, and current local protocols guiding practice differ between ICUs, both nationally and internationally. The views of professionals on glycaemic control can influence their practice. Cross-sectional, multicentre, survey-based study. An online short survey was sent to all physicians and nurses of seven ICUs, including questions on effective glycaemic control, treatment of hypoglycaemia and deviations from protocols' instructions. STROBE reporting guidelines were followed. Over half of the 40 respondents opined that a patient spending <75% admission time within the target glycaemic levels constituted poor glycaemic control. Professionals with more than 5years of experience were more likely to rate a patient spending 50%-74% admission time within target glycaemic levels as poor than less experienced colleagues. Physicians were more likely to rate a patient spending <50% admission time within target as poor than nurses. There was general agreement on how professionals would rate most deviations from their protocols. Nurses were more likely to rate insulin infusions restarted late and incorrect dosage of rescue glucose as major deviations than physicians. Most professionals agreed on when they would treat hypoglycaemia. When surveyed on various aspects of glycaemic control, ICU nurses and physicians often agreed, although there were certain areas of disagreement, in which their profession and level of experience seemed to play a role. Differing views on glycaemic control amongst professionals may affect their practice and, thus, could lead to health inequalities. Clinical leads and the multidisciplinary ICU team should assess and, if necessary, address these differing opinions.

Context We describe an ongoing multidisciplinary quality improvement project at a maternity hospital with a busy level 3 neonatal unit. The project involved all staff caring for newborns including midwives, nursery nurses, health care assistants and doctors. Problem Hypoglycaemia is a common presentation in newborns and second most common reason for term infant admissions to neonatal units in England. Delayed recognition and treatment of hypoglycaemia can lead to serious neurological deficit and death. Intervention An NHSLA audit was carried out in July 2012 to assess the care of neonates at risk of hypoglycaemia. This showed multiple problem areas including neonates not being managed as per the guideline and “at risk” neonates being monitored using incorrect proformas or not being monitored at all. The audit also revealed unnecessary glucose monitoring of some neonates who no longer required it. A survey of all staff involved in newborn care was carried out and factors contributing to the problem were identified at all levels. At an organisational level, there were obsolete proformas on the ward with different thresholds for referral and three differing guidelines available on the intranet. At team level, the survey revealed that midwifes felt it was difficult to contact a neonatal SHO for referral and that there was lack of consistency in advice provided. At an individual level, staff indicated a lack of education regarding the guideline and testing revealed a lack of familiarity, especially amongst trainees. Strategy for change Obsolete proformas were removed from clinical areas and out of date guidelines from the intranet. The current guideline was streamlined and summarised with the addition of a bedside algorithm. An education programme was implemented to disseminate this information, called the RHINO project, an acronym for Referral/Review for Hypoglycaemia/Hypothermia detected during Newborn Observations. Colourful posters were prominently placed on postnatal wards and teaching sessions were organised at postnatal ward handover to call attention to posters and key messages. Nursery nurses based on postnatal wards also continue to act as champions for the project to reinforce the message. Hypoglycaemia guideline education was added to the induction programme for new doctors. Measurement of improvement Further audits carried out at 1, 4 and 18 months showed 100% compliance with almost all criteria, compared with 68 to 89% in the original audit (see Table 1). An audit of neonates admitted to the neonatal unit with hypoglycaemia during the 6 months following implementation of the programme showed 100% and 91% compliance with thresholds for referral and admission respectively. Case review identified the non-compliance was caused by confusion over the discrepancy between blood sugar levels measured on bedside and blood gas machines. This led to a guideline amendment that blood sugars less than 2.5 mmol/L should now be confirmed with capillary gas sample. A further staff survey showed improvement in guideline familiarity. Lessons learnt Success of this quality improvement project relied on information from all members of the multidisciplinary team. Their survey responses helped us identify interventions required. We feel the presence of human champions to continue reinforcing the message has helped us maintain good practice. Message for others Our main message is the value of human factors to maintain good practice and involving all members of multidisciplinary team in quality improvement work. Our project has also shown the importance of addressing problems at all levels.

Development of a Diabetes Self-Management Screening Tool for the Acute Care Setting

Type 1 Diabetes in Children and Adolescents

Introduction &amp; Objective: More than 1.7 million adults in the U.S. live with type 1 diabetes (T1D), which requires daily management to maintain optimal glycemic levels and prevent serious complications. Daily self-management may lead to obsessionality over food choices and therefore affect self-management behaviors. For example, some adults with T1D may delay hypoglycemia treatment due to beliefs about fast-acting carbohydrates, while others may restrict particular foods or food groups to achieve glycemic control. This qualitative study explored the tension between food choices and beliefs about healthy living among adults with T1D. Methods: As part of a larger study on experiences of hypoglycemia self-management, participants using continuous glucose monitors (CGMs) ≥70% of the time for more than six months were recruited from a Midwest academic medical center. Maximum variation sampling included adults with T1D across different percentages of time spent in level 2 hypoglycemia (glucose level &amp;lt;54 mg/dL). Diabetes history and sociodemographic data were collected. A semi-structured interview explored the thoughts and behaviors of participants using CGMs. Inductive thematic analysis was conducted focusing on relationships with food during self-management. Results: Preliminary findings include the impact of food characterization (e.g., “healthy” or “unhealthy”) in hypoglycemia treatment, the influence of family/friends on treatment food choices, and ways adults with T1D reconcile their diabetes needs and personal lifestyle goals. Conclusions: These findings will add to the few studies on the specific responses to dietary intake of adults with T1D, particularly related to self-management. The results suggest the need for more mixed-methods research to understand the role of food beliefs in daily and long-term T1D self-management to inform better diabetes education and interventions. Disclosure J. Lucien: None. A. Agni: None. F.A. Amjad: None. S. Chuisano: None. Y. Lin: None. M. DeJonckheere: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK129724); Michigan Diabetes Research Center Diabetes Interdisciplinary Study Program Award (P30DK020572)

Context The project was undertaken at a level 3 NICU in a DGH in Surrey, UK, involving junior and senior doctors, midwives, nursery nurses, pharmacists and the pathology department. Problem Staff anecdotally felt the hypoglycaemia operational threshold was too high, monitors were inaccurate, blood sugar level (BSL) tests too frequent and management inconsistent. Treatment with formula feed supplements was hindering efforts to establish breastfeeding and prolonging stays. Assessment of problem and analysis of its causes Initial assessment involved an audit of current practice against Baby-Friendly Initiative standards and interviews with 62 multidisciplinary team members to explore concerns and collate ideas for improvement. To check equipment accuracy, 50 samples were tested for blood glucose on both the portable metres and blood gas machine, which found on average glucosmeters under-read by 0.5mmol/L (range 0–2.0mmol/L). A review of literature and other UK trust’s policies was carried out to identify best practice and alternatives to formula-feed supplementation. It was recognised that new equipment would need to be used for BSL monitoring and all staff would need to be trained in any policy changes. Intervention New guidelines lowered the working definition of hypoglycaemia, limited the number of BSL tests performed by stopping routine measurement of post-feed BSLs, and changed first line treatment of moderate hypoglycaemia (BSL >2mmol/L) from formula top-up to dextrose gel. A new proforma with step-by-step management plan and built in escalation was designed with the midwives. The pathology department is acquiring more accurate glucosmeters for the trust; in the meantime a “glucose only” micro-sample setting on NICU gas machine has been set up. Study design Audit of practice pre- and post- new management guidelines was undertaken to measure the number of needle pricks each baby had, number of days each infant at risk of hypoglycaemia was monitored for, supplementation rates, the number of babies treated for hypoglycaemia who were discharged breast feeding and still doing so at 3 months, and the number of infants admitted to NICU for management of hypoglycaemia. Strategy for change Management of hypoglycaemia guidelines were re-written and a new proforma produced within 6 months. This was sent to all Neonatal Consultants and senior midwives for review. All midwives and nursery nurses were trained by the authors and the point-of-care team in the new guidelines, how to take a capillary blood gas and how to run a glucose only sample. Audit of practice as outlined above was carried out for infants treated 6 months before and 6 months after guideline implementation, and the results fed back to the Neonatal Consultant body. Measurement of improvement Audit of practice showed post-implementation the average number of BSL tests per baby reduced by 73% (15 to 4 pricks) and average monitoring time reduced by 52%- saving 520hrs/month staff time. Breastfeeding rates at 3 months post discharge have doubled and provisional data shows a 38% reduction in SCU/NICU admissions for neonatal hypoglycaemia. Effects of changes Changes implemented meant more accurate blood sugar analysis, fewer needle pricks for infants, shorter admission time for infants at risk of hypoglycaemia, and decreased use of formula supplementation which has enabled the trust to apply for Level 3 Baby Friendly accreditation. Some senior staff were concerned the new proforma was too complicated; this was addressed through face-to-face consultation. Lessons learnt The most important lesson was the necessity of having all members of the multi-disciplinary team involved in the project from the beginning. Message for others Change to the status quo to improve patient care and experience is possible by quantifying a long-standing anecdotal problem and implementing evidence based practice.

Glucagon is essential for endogenous glucose regulation along with the paired hormone, insulin. Unlike insulin, pharmaceutical use of glucagon has been limited due to the unstable nature of the peptide. Glucagon has the potential to address hypoglycemia as a major limiting factor in the treatment of diabetes, which remains very common in the type 1 and type 2 diabetes. Recent developments are poised to change this paradigm and expand the use of glucagon for people with diabetes. Glucagon emergency kits have major limitations for their use in treating severe hypoglycemia. A complicated reconstitution and injection process often results in incomplete or aborted administration. New preparations include intranasal glucagon with an easy-to-use and needle-free nasal applicator as well as two stable liquid formulations in pre-filled injection devices. These may ease the burden of severe hypoglycemia treatment. The liquid preparations may also have a role in the treatment of non-severe hypoglycemia. Despite potential benefits of expanded use of glucagon, undesirable side effects (nausea, vomiting), cost, and complexity of adding another medication may limit real-world use. Additionally, more long-term safety and outcome data are needed before widespread, frequent use of glucagon is recommended by providers.

Hypoglycemia will occur on school grounds in students with diabetes who are receiving glucose-lowering drugs. Hypoglycemia may be severe, in which a student is unconscious or comatose. Fast-acting carbohydrates remain the first line of treatment for nonsevere hypoglycemia but preparedness with emergency injectable or intranasal glucagon is ideal. Students may not have their own glucagon devices, so unassigned or undesignated glucagon for use with any student in which glucagon is part of their hypoglycemia treatment plan is critical. Several states have laws permitting undesignated glucagon in schools, and school nurses residing in states without such laws could strongly advocate their state legislators to enact similar laws to ensure students in the nurses' care have access to this lifesaving treatment.

Quels enjeux thérapeutiques chez la personne âgée diabétique ?

Identification of highly concentrated dextrose solution (50% dextrose) extravasation and treatment—a clinical report