Flexible Insulin Research Articles

Sustaining the benefits of structured education: Participants' experiences of receiving structured individual support during a programme (DAFNEplus) informed by behavioural science.

The DAFNEplus programme seeks to promote sustained improvements in glycaemic management by incorporating techniques from behavioural science. It includes five sessions of structured individual support delivered over 12 months following group education. As part of a broader evaluation, and to inform decision-making about roll-out in routine care, we explored participants' experiences of, and engagement with, that individual support. We interviewed DAFNEplus participants (n = 28) about their experiences of receiving individual support and the impact they perceived it as having on their self management practices. We analysed data thematically. Participants described several important ways individual support had helped strengthen their self management, including: consolidating and expanding their understandings of flexible intensive insulin therapy; promoting ongoing review and refinement of behaviour; encouraging continued and effective use of data; and facilitating access to help from healthcare professionals to pre-empt or resolve emergent difficulties. Participants characterised themselves as moving towards independence in self management over the time they received individual support, with their accounts suggesting three key stages in that journey: 'Working with healthcare professionals'; 'Growing sense of responsibility'; and, 'Taking control'. Whilst all portrayed themselves as changed, participants' progress through those stages varied; a few continued to depend heavily on DAFNEplus facilitators for advice and/or direction at 12 months. While all participants benefited from individual support, our findings suggest that some may need, or gain further benefit from, longer-term, tailored support. This has important implications for decision-making about roll-out of DAFNEplus post-trial and for the development of future programmes seeking to bring about sustainable changes in self management practices.

FLEXIBLE INTENSIVE INSULIN THERAPY: PRACTICAL MODALITIES AND METABOLIC IMPACT

Background: Flexible intensive insulin therapy (FIT) is a therapeutic method aimed at reproducing physiological insulin secretion as rigorously as possible. The purpose of this study was to highlight the practicalities of FIT in our department in order to assess its outcomes on glycated hemoglobin (HbA1c) and severe hypoglycemia (SH) in baseline and after the follow-up of patients with type 1 diabetes. Methods: Over a period of 6 years, we retrospectively involved patients with type 1 diabetes who participated in an educational program of FIT during a 5-day hospitalization at the Endocrinology, Diabetology, and Nutrition department of the Hassan II University Hospital in Fez. Our study series was followed up at 3-6 and 12months after FIT to determine its effects on metabolic parameters. Results: The mean HbA1c decreased from 8.82% at baseline to 7.67% at follow-up in 3 months, 7.5% in 6 months to reach 7.16% in one year without increasing the risk of severe hypoglycemia. Indeed, the rate of hypoglycemia decreased significantly from 51.1% at baseline to 8.8% at follow-up (p = 0.011). Conclusion: Our results underscore the value of FIT education in improving glycemic control while decreasing episodes of hypoglycemia and providing patients with a better quality of life.

Intensive management from diagnosis improves HbA1c at 12 months postdiagnosis: results from a prospective cohort study in children with newly diagnosed type 1 diabetes

aims: To examine the impact of intensive management of type 1 diabetes (T1D) from diagnosis on HbA1c 12 months from diagnosis. methods: HbA1c measured 12 months after diagnosis for 70 consecutively newly diagnosed children with T1D following implementation of an intensive management protocol was compared with 70 children consecutively diagnosed immediately pre-implementation. Intensive management involved carbohydrate counting and flexible insulin dosing from first meal with subcutaneous insulin, targeted blood glucose levels from 4–8mmol/L irrespective of time of day, avoidance of twice daily insulin regimen and promotion of continuous glucose monitoring (CGM). HbA1c, diabetes technology use and insulin regimen at 12 months post-diagnosis were compared. results: The post-intensive management implementation cohort had an improved mean HbA1c of 58.2±15.3mmol/mol vs 63.7±10.7mmol/mol at 12 months (p=0.014). The proportion of young people with diabetes meeting a target HbA1c of <53mmol/mol at 12 months improved from 11% to 40% (p=<0.001). There was a reduction of twice daily insulin regimen from 66% to 11% (p=<0.001), and increased CGM use from 57% to 76% (p=0.02). conclusion: Intensive management when implemented with consistent messaging from the multi-disciplinary team resulted in clinic-wide improvements in HbA1c and the proportion meeting HbA1c targets.

Insulinothérapie fonctionnelle chez les diabétiques de type 1: Impact à court terme sur le poids et les apports nutritionnels

Flexible insulin therapy is currently considered the gold standard therapy of type 1 diabetes. We aimed to study the evolution of glycemic control, weight and nutritional intake of a group of patients with type 1 diabetes, three months after the initiation of functional insulin therapy (FIT). This was a prospective longitudinal study having included 30 type 1 diabetic patients hospitalized for education to FIT. Each patient underwent an assessment of glycemic control (glycated hemoglobin (A1C) and number of hypoglycemia), weight and nutritional intake before FIT and 3 months after the initiation of this educative approach. The mean age of patients was 21,8 ± 7,9 years and the sex ratio was 0,5. The mean duration of diabetes was 7,2 ± 6 years. Three months after initiation of FIT, we observed a significant lowering of A1C, which went from 9,2 ± 1,6% to 8,3 ± 1,4% (p<0,001) of the number of minor hypoglycemia (p=0,001) and that of severe hypoglycemia (p= 0,021). the average weight went from 64,6 ± 13,1 kg to 65,5 ± 13,5 kg (p = 0,040) with a significant increase in BMI (p = 0,041). Weight gain was observed in 67% of patients. This weight gain contrasted with a significant decrease in caloric (p = 0,040) and in carbohydrates intakes (p = 0,027). Weight gain, associated with better glycemic control, should encourage the healthcare team to strengthen therapeutic education of patients undergoing FIT in order to limit weight gain.

Multiple daily injection insulin regimen is an effective, and more economical, alternative to continuous insulin infusion for type 1 diabetics

A clinical decision report using: Heller S, White D, Lee E, et al. A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Health Technol Assess. 2017 Apr;21(20):1-278. https://doi.org/10.3310/hta21200 for a patient with type 1 diabetes.

Participants' experiences of attending a structured education course (DAFNEplus) informed by behavioural science.

As part of a broader process evaluation, we explored participants' experiences of, and engagement with, the DAFNEplus programme's group-based structured education course. This course, which was informed by behavioural science, provided participants with education and instruction to use flexible intensive insulin therapy (FIIT) together with techniques to identify and address unhelpful cognitive and emotional influences on their type 1 diabetes self-management. We interviewed n = 28 DAFNEplus participants. Data were analysed thematically and took account of previous work exploring individuals' experiences of standard DAFNE courses. As well as benefitting from the DAFNEplus course's skills-based training and educational curriculum, participants' accounts suggested they had experienced cognitive and emotional changes that had positively influenced their confidence and motivation to adopt and sustain the use of FIIT. These benefits were most keenly felt by those who reported negative emotional states and mind-sets pre-course which had made their diabetes self-management challenging. Participants' cognitive and emotional changes were enabled through techniques used during the course to normalise setbacks and imperfect diabetes self-management, capitalise upon group synergies and encourage the use of social support, including from healthcare professionals. Participants also highlighted motivational gains arising from being reassured that diabetes complications are not common or inevitable if a FIIT regimen is followed. Our findings suggest that offering training in FIIT, in conjunction with behaviour change techniques that target unhelpful mindsets and emotional resilience, may be more effective in promoting diabetes self-management than offering education and skills training alone.

390-P: Improving Quality of Life and Self-Efficacy through a Hypoglycemia Management Program—The HARPdoc Randomised Controlled Trial

Background: A significant minority (15-18%) of adults with type 1 diabetes (T1D) continue to experience problematic hypoglycemia despite access to structured education in flexible insulin therapy and advanced technologies. Many have impaired awareness of hypoglycemia, now recognised to be associated with significant mental health burden. The HARPdoc trial (Hypoglycemia Awareness Restoration Program for people with problematic hypoglycemia Despite Optimised Care) showed that a group programme focused on cognitions and motivation improved scores for diabetes distress, anxiety and depression compared to BGAT (blood glucose awareness training, which addresses education and behaviours), with similarly reduced rates of severe hypoglycaemia. Methods: This exploratory study addresses the further impact of these programmes on quality of life and mental health. Quality of life was measured at baseline with EQ-5D-5L and it and service use (Adult Service Utilisation Schedule) were measured at 12 and 24 months after randomised participation to either HARPdoc or BGAT. Results: Mean EQ-5D scores rose by 14%, +0.1 HRQoL utility score (HUS), over 24 months in HARPdoc and fell by 1%, -0.007 HUS in BGAT. Use of mental health services after HARPdoc or BGAT was 26 vs 56 contacts with a psychiatrist, psychologist or counsellor in months 0-12 and 1 vs 17 contacts in months 13 - 24 respectively. Conclusions: We conclude that HARPdoc reduces previously treatment-resistant severe hypoglycaemia in adults with type 1 diabetes but also enhances quality of life, whilst reducing use of mental health services. We hypothesise that the psychosocial aspects of HARPdoc increase self-efficacy and coping skills, thereby reducing disease burden and the need to access general and mental healthcare provision. Disclosure S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. E.Toschi: Advisory Panel; Eli Lilly and Company. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.A.Stadler: None. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. N.De zoysa: None. Funding JDRF (4-SRA-2017-266-M-N); National Institute of Health Research UK

A metamodel-based flexible insulin therapy for type 1 diabetes patients subjected to aerobic physical activity

Patients with type 1 diabetes are subject to exogenous insulin injections, whether manually or through (semi)automated insulin pumps. Basic knowledge of the patient’s characteristics and flexible insulin therapy (FIT) parameters are then needed. Specifically, artificial pancreas-like closed-loop insulin delivery systems are some of the most promising devices for substituting for endogenous insulin secretion in type 1 diabetes patients. However, these devices require self-reported information such as carbohydrates or physical activity from the patient, introducing potential miscalculations and delays that can have life-threatening consequences. Here, we display a metamodel for glucose-insulin dynamics that is subject to carbohydrate ingestion and aerobic physical activity. This metamodel incorporates major existing knowledge-based models. We derive comprehensive and universal definitions of the underlying FIT parameters to form an insulin sensitivity factor (ISF). In addition, the relevance of physical activity modelling is assessed, and the FIT is updated to take physical exercise into account. Specifically, we cope with physical activity by using heart rate sensors (watches) with a fully automated closed insulin loop, aiming to maximize the time spent in the glycaemic range (75.5% in the range and 1.3% below the range for hypoglycaemia on a virtual patient simulator).These mathematical parameter definitions are interesting on their own, may be new tools for assessing mathematical models and can ultimately be used in closed-loop artificial pancreas algorithms or to extend distinguished FIT.

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT

Aims/hypothesisProblematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia.MethodsWe documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81).ResultsThe HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0–12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group.Conclusions/interpretationThe HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies.Graphical abstract

Too Much Dietary Flexibility May Hinder, Not Help: Could More Specific Targets for Daily Food Intake Distribution Promote Glycemic Management among Youth with Type 1 Diabetes?

Average glycemic levels among youth with type 1 diabetes (T1D) have worsened in some parts of the world over the past decade despite simultaneous increased uptake of diabetes technology, thereby highlighting the persistent need to identify effective behavioral strategies to manage glycemia during this life stage. Nutrition is fundamental to T1D management. We reviewed the evidence base of eating strategies tested to date to improve glycemic levels among youth with T1D in order to identify promising directions for future research. No eating strategy tested among youth with T1D since the advent of flexible insulin regimens—including widely promoted carbohydrate counting and low glycemic index strategies—is robustly supported by the existing evidence base, which is characterized by few prospective studies, small study sample sizes, and lack of replication of results due to marked differences in study design or eating strategy tested. Further, focus on macronutrients or food groups without consideration of food intake distribution throughout the day or day-to-day consistency may partially underlie the lack of glycemic benefits observed in studies to date. Increased attention paid to these factors by future observational and experimental studies may facilitate identification of behavioral targets that increase glycemic predictability and management among youth with T1D.

The Benefits of Carbohydrate Counting in Type 1 Diabetes Mellitus : A Scoping Review

Backgrounds: Carbohydrate intake is a major determinant of blood glucose stability in patients with type 1 diabetes. Carbohydrate counting as a meal planning approach for patients with type 1 diabetes is known to have flexibility in controlling blood glucose by regulating the amount of carbohydrate intake and insulin dose, yet a good understanding about carbohydrate counting practices is still needed in order to achieve blood glucose control targeted blood glucose control.Objectives: this article aims to review the result of previous studies relating to effect, impact and benefits in metabolic control, anthropometry, also impact and practices of education relating to carbohydrate counting in type 1 diabetes.Discussion: Carbohydrate counting has an impact on HbA1c, body mass index, waist circumference, diabetes-related quality of life and type 1 diabetes therapy satisfaction. Effects of carbohydrate counting depends on age, diet management, ability to calculate ideal insulin requirements, provided education, patient readiness to apply carbohydrate counting, family support, and additional interventions provided to support improved metabolic control. The use of Automated Bolus Calculator (ABC) with carbohydrate counting and FIIT simultaneously was thought to be able to support the effectiveness of type 1 diabetes mellitus therapy.Conclusions: Carbohydrate counting can improve metabolic control in children, adolescents and adults with type 1 diabetes. It is necessary to emphasize continuous education by registered dietitian using media in estimating the portion of food and insulin doses, also involving parents to improve the accuracy of carbohydrate counting in children and adolescents.The combination of Automated Bolus Calculator (ABC) and Flexible Intensive Insulin Therapy (FIIT) is known to increase carbohydrate counting effectiveness in type 1 DM therapy.

The first and only combination of basal and prandial insulin analogs degludec and aspart: the position of Russian endocrinologists

Insulin therapy for diabetes mellitus is the most effective way to control glycemia with the progression of the disease and the ineffectiveness of other sugar-lowering drugs. At the same time, the existing limitations of traditional insulin preparations, along with increasing attention to the individualized treatment of this disease, are pushing developers to create drugs that most closely reproduce the effect of natural human insulin. In this regard, the appearance of a combination of insulin analogs, the action profile of which practically imitates insulin secretion by a healthy pancreas, presents new possibilities in the treatment of diabetes mellitus. Insulin degludec / insulin aspart (IDegAsp, Ryzodeg®, Novo Nordisk, Denmark) is the first and only soluble combination preparation containing 70% of the ultra-long-acting insulin analogue degludec and 30% of the ultra-short-acting insulin analogue aspart in one injection, which meets the need for both basal and prandial insulin. The combined drug has nothing in common with traditional mixed insulin preparations (both human and analog) and provides doctors and patients with significant advantages over the latter. The article presents the position of Russian experts-diabetologists with extensive experience in the use of IDegAsp regarding the role and place of the drug in real clinical practice. Data from real clinical practice confirm that IDegAsp is a reasonable choice for starting and intensifying insulin therapy for type 2 diabetes mellitus when basal and prandial glycemic control is required. The use of the drug is most appropriate in patients who are on basal, biphasic, basal-plus/basal-bolus regimens and who do not achieve the goals of glycemic control during prior therapy. One of the leading reasons for choosing IDegAsp may also be a lower risk of developing hypoglycemia compared to insulin analogues of previous generations — biphasic insulin aspart and basal insulin glargine 100 U/ml. In addition, IDegAsp is a simple, flexible and safe insulin therapy for patients on premix therapy and basal-plus/basis-bolus regimens who require basal and prandial glycemic control. IDegAsp is a simple, flexible and safe insulin therapy. The greatest benefit of this drug use can be obtained by patients for whom adherence to a complex therapy regimen is difficult (the elderly, with cognitive impairment, after a stroke, with dementia), as well as patients who have an active lifestyle, accompanied by irregular food intake. It is important to note that since January 1, 2021, there is no need for a decision by a special medical commission to prescribe (IDegAsp) Ryzodeg®. This fact, as well as a significant price reduction at the end of 2020, opens up broader prospects for using the drug in the routine practice of a Russian endocrinologist.

Flexible insulin therapy improves metabolic control and decreases the risk of hypoglycemia in type 1 diabetic patients.

Introductionflexible insulin therapy (FIT) is considered as a crucial turning point in the management of type 1 diabetes. The purpose of this study was to evaluate the impact of this optimum therapeutic approach on improving metabolic control and decreasing hypoglycemic events in patients with type 1 diabetes.Methodsthirty-seven type 1 diabetic patients were included in a five days training programme of FIT. They had an HbA1c between 7.5 and 10%. Those patients were enrolled in a flexible insulin program and we evaluate clinical and metabolic parameters (glycated haemoglobin (HbA1c), hypoglycemic events, body mass index (BMI) and the rate of blood glucose measurements) before the course of FIT and 3, 6 and 9 months after the course.Resultsover a 9 months period of the study, the frequency of mild hypoglycemia decreased from 11.7 to 1.7 episodes/3 months (p = 0.005). The baseline HbA1c value improved by 1% at 3 months with an increase of 0.2% at 6 months, which remained unchanged at 9 months (p = <0.0001). Patients who were poorly controlled (HbA1c ≥ 8%) improved their baseline HbA1c value from 9.2% to 8.0% (p = <0.0001).Conclusionthe present study confirms that a structured training programme for FIT improves glycemic control and decreases hypoglycemic events in patients with type 1 diabetes and it can be adopted in countries with weak or intermediate income (e.g. Morocco), which allows those patients to take advantages of this therapeutic approach.

Revision of Alberta’s Provincial Insulin Pump Therapy Criteria for Adults and Children With Type 1 Diabetes: Process, Rationale and Framework for Evaluation

ObjectivesInsulin pump therapy is a valuable, but costly approach, with public funding in Alberta for eligible individuals since 2013. The Provincial Insulin Pump Therapy Program Clinical Advisory Committee has revised and updated the clinical criteria, integrating current literature, best practice and feedback from clinicians. The objective was to develop criteria that would: 1) optimize safety and effectiveness of insulin pump therapy, while 2) carefully stewarding resources available to care for people with type 1 diabetes. MethodsThe Clinical Advisory Committee comprised health-care professionals with expertise in pump therapy and included adult and pediatric endocrinologists, an internist, a pediatrician, certified pump trainers, diabetes educators and clinic managers. The group meets regularly by teleconference. Decisions are made by consensus. ResultsIndications for insulin pump therapy for adults and children with insulin-deficient diabetes were divided into 4 hierarchical levels: 1) problematic hypoglycemia, inability to achieve acceptable control or progressive complications; 2) unpredictable activity, dawn phenomenon or children for whom use of multiple daily injections is not appropriate; 3) individual preference and 4) clinical exception, with priority given to indications with clear evidence of benefit. The criteria emphasize the importance of: 1) adequate education in diabetes self-management; 2) adequate trial of flexible insulin therapy with modern analogues and 3) evidence of active, safe diabetes self-management. Tools to facilitate effective and efficient annual review and surveillance were developed incorporating biological, behavioural evaluation and self-reflection to provide a framework for program evaluation. The recommendations were implemented in January 2019. ConclusionsThe process and revised criteria may be valuable for jurisdictions considering how to develop and implement a publicly funded insulin pump program.

Flexible Insulin Therapy: Results of a Tunisian Experience

Aims: To evaluate the adherence of type 1 diabetic patients to long-term flexible insulin therapy (FIT), and the impact of this approach on the glycemic balance, basal insuline dose and quality of life of patients.&#x0D; Methods: This is a rospective descriptive study, conducted between January and April 2017, including 50 patients with type 1 diabetes having following the FIT of department B of Endocrinology-Diabetology and Metabolic Diseases service B at the National Institute of Nutrition and Food Technology of Tunis.&#x0D; Results: The FIT decreased mean HbA1c from 8.96% to 7.57% (p=0.04) and mean basal insulin dose from 0.35 to 0.27 IU/kg /day. Hypoglycemia's frequency decreased from 3.2±2.1 to 0.93±2.1 episodes /patient /week (p=0.03), with improved quality of life. However, there was a significant weight gain (p=0.02).&#x0D; Conclusions: FIT allows for better glycemic control while reducing hypoglycemia, especially severe episodes, and improves the quality of life of patients with type 1 diabetes but seems to cause weight gain.

Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial

People with type 1 diabetes who use continuous subcutaneous insulin infusion (CSII, or insulin pump therapy) often remove their pump before extended periods of exercise, but this approach might result in reduced glycaemic control and increased risk of hyperglycaemia and ketogenesis. We aimed to assess the efficacy and safety of a hybrid approach, in which basal insulin delivery was divided between CSII and a daily injection of insulin degludec. In this single-centre, open-label, proof-of-concept, randomised crossover trial done at the LMC Diabetes & Endocrinology research centre, we recruited physically active and aerobically fit participants aged 18 years or older with type 1 diabetes who were using CSII. Participants were randomly assigned (1:1) by use of a computer-generated sequence to one of two sequences of either usual CSII, involving the continuation of the participant's usual CSII regimen, followed by crossover to hybrid CSII, in which the delivery of the participant's usual daily basal insulin dose was split (50% delivered by CSII and 50% delivered by a once-daily morning injection of 100 U/mL insulin degludec), or the opposite sequence (ie, hybrid CSII followed by crossover to usual CSII). Treatment was not masked to the investigators or participants. For each intervention, participants completed a moderate-intensity and a high-intensity in-clinic exercise session in the first week, followed by four high-intensity and two moderate-intensity home-based exercise sessions in the subsequent 3 weeks. Insulin pumps were suspended or disconnected 60 min before exercise and reconnected immediately after exercise during both treatment regimens. The coprimary outcomes were: (1) time spent in the target control range of 4·0-10·0 mmol/L blood glucose after high-intensity exercise, and (2) time spent in target control range of 4·0-10·0 mmol/L blood glucose after moderate-intensity exercise, measured by continuous glucose monitoring in the 6-h period from the start of the high-intensity and moderate-intensity in-clinic exercise sessions. Outcomes were assessed in a modified intention-to-treat population that included all participants who started both intervention phases and completed all of the in-clinic exercise visits. This trial is registered with ClinicalTrials.gov, NCT03838783, and is complete. Between May 15, 2018, and March 5, 2019, we assessed 43 patients for eligibility, of whom 31 were randomly assigned to receive the usual CSII regimen (n=14) or hybrid CSII regimen (n=17) in the first phase (before crossover). The analysis population consisted of 24 participants who completed both study phases. Compared with the usual CSII regimen, participants on the hybrid CSII regimen had a significantly longer time in blood glucose range of 4-10 mmol/L during the 6-h period from the start of both moderate-intensity (mean difference 86 min [95% CI 61-147], p=0·005; percentage time in range 64% [SD 35] vs 40% [35]) and high-intensity in-clinic exercise session (60 min [11-109], p=0·01; 66% [32] vs 50% [27]). Participants on the hybrid CSII regimen also showed a higher time in blood glucose range of 4-10 mmol/L during home-based exercise sessions (mean difference 23 min [95% CI -1 to 46], p=0·055), with significantly lower time spent in hyperglycaemia than participants on the usual CSII regimen (mean difference 25 min [2-48], p=0·04). These exploratory outcomes also showed no significant difference in the amount of time spent in hypoglycaemia, nor the number of hypoglycaemic events, between the two interventions. There were three study-related adverse events reported with the usual CSII regimen (two hypotension events and one nausea event) and four with the hybrid CSII regimen (two hypotension events and two nausea events). A hybrid regimen of injected insulin degludec and CSII (with pump removal during exercise) appears to be safe and effective in adults with type 1 diabetes who exercise regularly. This approach could offer improved glycaemic control immediately after exercise and should be further assessed in a larger-scale randomised trial. Novo Nordisk.

What are the characteristics of the best type 1 diabetes patient education programmes (from diagnosis to long-term care), do they improve outcomes and what is required to make them more effective?

The last 20 years have witnessed a marked change in approaches to the management of type 1 diabetes in the UK. This is exemplified by National Institute of Health and Care Excellence (NICE) guidance which acknowledges that reaching and maintaining target glucose depends on people with type 1 diabetes effectively implementing flexible intensive insulin therapy. The guidance emphasizes that successful self-management requires the acquisition of complex skills and is best achieved by participation in high-quality structured education. Controlled trials and other research have shown that programmes teaching self-management can lower glucose levels while reducing hypoglycaemia, improve psychological outcomes and are highly cost-effective. An important principle of successful programmes is therapeutic education in which learning becomes a partnership between the professional and the person with diabetes who learns to fit diabetes into his/her everyday life. Other recommended elements of programmes include a written curriculum, group teaching by a professional multidisciplinary team and quality assurance. Yet many participants struggle post-course to implement and maintain skills, and overall HbA1c levels, particularly in the UK, remain far from target. Recent studies have identified the barriers to sustained effective self-management and concluded that even high-quality programmes generally lack critical components. These include incorporating evidence from behaviour change research, exploiting the promise of new technologies in reducing the burden of self-management, and providing structured professional support once people have completed the training. Studies are currently underway to evaluate structured training courses which have added these elements and examine whether they can lower glucose to levels closer to target without impairing quality of life.

Practical identification of a glucose-insulin dynamics model

Glycemia regulation algorithms which are designed to be implemented in several artificial pancreas projects are often model based control algorithms. However, actual diabetes monitoring is based throughout the world on the so-called Flexible Insulin Therapy (FIT) which does not always cope with current mathematical models. In this paper, we initiate an identification methodology of those FIT parameters from some standard ambulatory clinical data. This issue has an interest per se, or for a further use in any closed-loop regulation system.

Biosimilars and Novel Insulins.

Insulin therapy is the mainstay of treatment for type 1 diabetes and may be necessary in type 2 diabetes. Current insulin analogues present a more physiological profile, are effective, and with less risk of hypoglycemia, but they are expensive. Biosimilar insulins should offer the advantages of insulin analogues at reduced costs. In addition, current rapid-acting insulin analogues are not fast enough to control excessive postprandial glucose excursions in many patients. Biosimilar insulins demonstrated that are safe and effective, but interchangeability and automatic substitution remain an issue. Ultrafast-acting insulins should reduce postprandial hyperglycemia and improve flexibility in insulin dosing. This systematic review was conducted following widely recommended methods. We searched for each topic in Medline, Embase, the Cochrane Library, and SCISEARCH for relevant citations for the appropriate period. LY2963016 and MK-1293 are biosimilar insulins of insulin glargine, and SAR342434 is a biosimilar of insulin lispro. The abbreviated developed program demonstrated comparable efficacy and safety and supports their use for treatment of people with diabetes but no interchangeability. Faster-acting insulin aspart is a new formulation of insulin aspart with accelerated subcutaneous absorption. Faster aspart demonstrated noninferiority in reducing HbA1c as compared to insulin aspart with superiority in controlling postprandial hyperglycemia without increasing hypoglycemia, and flexible insulin dosing. Biosimilar insulins have comparable PK-PD profiles and equivalent efficacy and safety to original insulins at a lower price, making them available for more people with diabetes. Faster aspart is the first ultrafast-acting insulin. New upcoming clinical trials and more clinical experience with faster aspart will show the real potential of this new insulin.

Carbohydrate counting accuracy in adults with cystic fibrosis related diabetes.

Poorly controlled Cystic Fibrosis-Related Diabetes (CFRD) is associated with adverse impacts on lung function and nutritional status. Insulin therapy is the only recommended medical treatment. Carbohydrate Counting (CC) is used to guide insulin doses and can assist in achieving optimal postprandial blood glucose levels. This study aimed to determine the prevalence of individuals with CFRD who carbohydrate count, explore barriers to its use and assess the accuracy of CC in hospitalised patients. A cross-sectional, mixed-methods, descriptive study recruited individuals with CFRD hospitalised at an Australian tertiary hospital. Consenting patients completed a questionnaire. Patients were asked to estimate the carbohydrate content of their ordered meals provided by hospital foodservices. The study dietitian assessed each meal's estimation against the actual content. 17 individuals were recruited to this study and five declined. Seven had a fixed insulin regimen, and ten had a flexible insulin regimen and used CC. Patients in the fixed insulin group reported lower levels of confidence in their ability to carbohydrate count (P < .001) and placed less importance on CC (P < .001). 53% of the fixed insulin group's and 41.7% of the flexible insulin group's estimations of the carbohydrate content of the hospital food items were accurate. Of those patients recruited to this study, 59% used CC as a tool to guide insulin dosing, and patients estimated accurate carbohydrate values in only 46% of meals. Further research is warranted to investigate the most suitable method to assist accurate carbohydrate content estimations in a hospital setting.