Basal Bolus Research Articles

Adherence to insulin treatment in insulin-naïve type 2 diabetic patients initiated on different insulin regimens.

ObjectiveWe aimed to evaluate adherence to insulin treatment in terms of treatment persistence and daily adherence to insulin injections among insulin-naïve type 2 diabetic patients initiating insulin therapy with basal (long acting), basal-bolus, and premixed insulin regimens in a tertiary endocrinology outpatient clinic.MethodsA total of 433 (mean age of 55.5±13.0 years; 52.4% females) insulin-naïve type 2 diabetic patients initiated on insulin therapy were included in this questionnaire-based phone interview survey at the sixth month of therapy. Via the telephone interview questions, patients were required to provide information about persistence to insulin treatment, self-reported blood glucose values, and side effects; data on demographics and diabetes characteristics were obtained from medical records.ResultsSelf-reported treatment withdrawal occurred in 20.1% patients, while 20.3% patients were nonadherent to daily insulin. Negative beliefs about insulin therapy (24.1%) and forgetting injections (40.9%) were the most common reasons for treatment withdrawal and dose skipping, respectively. Younger age (49.5±15.0 vs 56.4±12.0 years) (P=0.001) and shorter duration of diabetes (4.8±4.3 vs 8.8±6.3 years) (P=0.0008) and treatment duration (5.2±2.4 vs 10.7±2.4 months) (P=0.0001) were noted, respectively, in discontinuers vs continuers. Basal bolus was the most commonly prescribed insulin regimen (51.0%), while associated with higher likelihood of skipping a dose than regular use (61.3% vs. 46.0%, P=0.04).ConclusionsPersistence to insulin therapy was poorer than anticipated but appeared to be higher in patients with the basal bolus regimen. Negative perceptions about insulin therapy seemed to be the main cause for poor adherence in our cohort.

Can laboratory based research regarding type 1 diabetes and exercise be applied into the real‐life environment?

AbstractThe aim of this study was to determine whether results from laboratory based research examining glycaemic control during and after exercise can be applied to a real‐life (non‐laboratory) environment.A comparative study of individuals with type 1 diabetes (n = 9) using basal bolus analogue insulin regimens was undertaken. Glycaemic control before and after two 40‐minute runs at 70% VO2 max, in both laboratory and real‐life environments, was measured across 10 time‐points during and up to 12 hours after exercise. Insulin was adjusted in all participants following a self‐management algorithm.Pooled mean glucose concentrations at each time‐point were compared. There was no statistically significant difference (F[1, 8] = 1.489, p = 0.257) in overall mean glucose concentrations between environments. Similarly, the exercise environment or time‐point of measurement had no statistically significant effect on mean glucose concentration (F[9, 72] = 0.499, p = 0.871). However, during exercise, episodes of both hypoglycaemia (<4.0 mmol/L) and hyperglycaemia (>9.0 mmol/L) were more frequent in the laboratory environment than in the real‐life environment: 5 vs 1 and 25 vs 19 episodes, respectively; the frequency of acceptable concentrations (4.0–9.0 mmol/L) was greater in the real‐life environment (24 vs 34). In the 8–12 hours after exercise, hypoglycaemia occurred more frequently in the real‐life environment (3 vs 8) with hyperglycaemia occurring more frequently in the laboratory environment (22 vs 14); again, there were slightly increased acceptable concentrations in the real‐life environment (29 vs 33).The exercise environment does not appear to affect overall mean blood glucose concentrations. However, it may affect the timing and frequency of hypoglycaemia and hyperglycaemia. Copyright © 2015 John Wiley & Sons.

Safety of basal-bolus versus premixed insulin intensification regimens in the management of type 2 diabetes mellitus: A narrative review of a 14-year experience

Abstract Objectives The best insulin regimen for the intensification of insulin therapy in the management of type 2 diabetes mellitus (T2DM) remains controversial. Despite substantial research, the body of evidence concerning the safety aspects of such regimens has never been summarized. We conducted a 14-year narrative review to compare the safety outcomes of basal-bolus (BB) versus premixed (PM) insulin regimens. Methods We searched electronic databases (PubMed, Scopus, Proquest and Google Scholar) for English-language studies published from January 2000 to December 2014 to identify studies comparing insulin intensification regimens. Only studies measuring the safety-related parameters of the specific regimens in T2DM adult patients were selected for further review. The extracted data were independently reviewed by two researchers, and disagreements were resolved by discussion. Results Of the 20 retrieved studies, we included 10 studies that specifically compared the safety parameters of BB and PM Insulin regimens. Among the safety outcomes measured were hypoglycaemia, weight gain and adverse events. Broadly, we determined that the BB insulin regimens were comparable to the PM insulin regimens in terms of hypoglycaemia and adverse events. In terms of weight gain, two of seven studies showed significant weight gain in BB insulin regimen arms. Conclusions Generally, the safety profile of BB insulin regimen was comparable to that of the PM insulin regimen. None of the identified studies performed head-to-head comparisons utilizing human insulin regimens in both arms. Research comparing non-analogue insulin regimens is warranted.

Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300UmL(-1) and Glargine 100UmL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study.

IntroductionNew insulin glargine 300 U mL−1 (Gla-300) is a basal insulin that shows more stable and prolonged pharmacokinetic and pharmacodynamic profiles than insulin glargine 100 U mL−1 (Gla-100). This study used continuous glucose monitoring (CGM) to compare 24-h glucose profiles in a Japanese population using Gla-300 versus Gla-100.MethodsThis was an exploratory 8.4-week, single-center, 2-sequence, 2-period, open-label crossover study. Japanese adults with type 1 diabetes mellitus (T1DM) treated with basal–bolus insulin, with glycated hemoglobin (HbA1c) 6.5–10.0% and median fasting self-monitored plasma glucose concentration ≤13 mmol L−1, were randomized to Gla-300 followed by Gla-100 (subgroup 1) or vice versa (subgroup 2), with no washout period. CGM was performed on the last 3 days of the screening period and each treatment period. Primary endpoint was comparison of 24-h glucose variability (area under the curve [AUC]mean_24 h) on the second day of each CGM measurement with Gla-300 versus Gla-100. Baseline and end of treatment period values for HbA1c, fasting plasma glucose (FPG) and daily basal/mealtime insulin doses were recorded. Hypoglycemia and adverse events (AEs) were recorded.ResultsTwenty participants were randomized (10 to subgroup 1 and 10 to subgroup 2). Participants showed comparable glucose variability over 24 h (AUCmean_24 h during treatment with Gla-300 or Gla-100 (treatment ratio 0.96; 90% confidence interval 0.79, 1.16). HbA1c and FPG were generally stable across both treatment periods. There was a trend towards fewer participants experiencing ≥1 hypoglycemia event at any time (24 h) and at night (00:00–05:59 h) with Gla-300 versus Gla-100. Treatment-emergent AEs, reported by 9/20 (45%) and 4/20 (20%) participants during Gla-300 and Gla-100 treatment, respectively, were unrelated to study medication.ConclusionsIn this cohort of Japanese people with T1DM, no between-treatment difference was observed in glucose variability with Gla-300 versus Gla-100, as measured by CGM. There was a trend for less hypoglycemia with Gla-300, particularly at night, versus Gla-100. Both treatments were well tolerated.FundingSanofi, Tokyo, Japan. Clinical trial registration: NCT01676233, ClinicalTrials.gov.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0115-1) contains supplementary material, which is available to authorized users.

Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway

Background:Lixisenatide is a potent, selective and short-acting once daily prandial glucagon-like peptide-1 receptor agonist which lowers glycohemoglobin and body weight by clinically significant amounts in patients with type 2 diabetes treated with basal insulin, with limited risk of hypoglycemia.Objective:To assess the cost-effectiveness of lixisenatide versus bolus insulin, both in combination with basal insulin, in patients with type 2 diabetes in Norway.Methods:The IMS CORE Diabetes Model, a non-product-specific and validated simulation model, was used to make clinical and cost projections. Transition probabilities, risk adjustments and the progression of complication risk factors were derived from the UK Prospective Diabetes Study, supplemented with Norwegian data. Patients were assumed to receive combination treatment with basal insulin, lixisenatide or bolus insulin therapy for 3 years, followed by intensification of a basal–bolus insulin regimen for their remaining lifetime. Simulated healthcare costs, taken from the public payer perspective, were derived from microcosting and diagnosis related groups, discounted at 4% per annum and reported in Norwegian krone (NOK). Productivity costs were also captured based on extractions from the Norwegian Labor and Welfare Administration. Health state utilities were derived from a systematic literature review. Sensitivity and scenario analyses were performed.Results:Lixisenatide in combination with basal insulin was associated with increased quality-adjusted life years (QALYs) and reduced lifetime healthcare costs compared to bolus insulin in combination with basal insulin in patients with Type 2 diabetes, and can be considered dominant. The net monetary benefit of lixisenatide versus bolus insulin was NOK 39,369 per patient. Results were sensitive to discounting, the application of excess body weight associated disutility and uncertainty surrounding the changes in HbA1c.Conclusions:Lixisenatide may be considered an economically efficient therapy in combination with basal insulin in the Norwegian setting, due to cost savings, weight loss and associated gains in health-related quality of life.

Feasibility of intensive insulin therapy in a developing country – the Indian experience

The superiority of the Intensive insulin regimen over the conventional split mix is very well established in Western centres, often considered a prelude to pump therapy. Developing countries find it a challenge to initiate Basal bolus therapy. The main problems include: lack of support systems in school environment to take up the injections and glucose monitoring at school, and difficulties in assessing carbohydrate content of native foods prepared at home (considering the variability in preparation of any given food item). The parental acceptance of five injections a day also remains a challenge. There are numerous extraneous influences and myths in minds of parents that discourage them from accepting this regimen. We present our experience in surmounting these challenges and establishing Intensive insulin therapy as a first line of insulin therapy and also share the advantages in terms of the glycemic control and growth of children on follow-up with us.

Classifying insulin regimens--difficulties and proposal for comprehensive new definitions.

Modern insulin regimens for the treatment of type 1 diabetes are highly individualized. The concept of an individually tailored medicine accounts for a broad variety of different insulin regimens applied. Despite clear recommendations for insulin management in children and adolescents with type 1 diabetes there is little distinctiveness about concepts and the nomenclature is confusing. Even among experts similar terms are used for different strategies. The aim of our review--based on the experiences of the Hvidoere Study Group (HSG)--is to propose comprehensive definitions for current insulin regimens reflecting current diabetes management in childhood and adolescence. The HSG--founded in 1994--is an international group representing 24 highly experienced pediatric diabetes centers, from Europe, Japan, North America and Australia. Different benchmarking studies of the HSG revealed a broad variety of insulin regimens applied in each center, respectively. Furthermore, the understanding of insulin regimens has been persistently different between the centers since more than 20 yr. Not even the terms 'conventional' and 'intensified therapy' were used consistently among all members. Besides the concepts 'conventional' and 'intensified', several other terms for the characterization of insulin regimens are in use: Basal Bolus Concept (BBC), multiple daily injections (MDI), and flexible insulin therapy (FIT) are most frequently used, although none of these expressions is clearly or consistently defined. The proposed new classification for insulin management will be comprehensive, simple, and catchy. Currently available terms were included. This classification may offer the opportunity to compare therapeutic strategies without the currently existing confusion on the insulin regimen.

Delayed hypoglycaemia in people with type 1 diabetes after performing moderate intensity exercise before the evening meal

AbstractFor a person with type 1 diabetes, participation in exercise may increase the risk of hypoglycaemia. Research has been performed during or immediately after exercise in a laboratory environment, with limited evidence regarding strategies for post‐exercise hypoglycaemia prevention.The aim of this study was to investigate the occurrence of delayed hypoglycaemia after 40 minutes of moderate intensity exercise at 70% VO2 max before the evening meal, in both the real‐life and laboratory exercise environments.Nine individuals (five males, four females) with type 1 diabetes using basal bolus analogue insulin regimens participated. All performed two sessions of 40 minutes of moderate intensity exercise in two environments (laboratory and real‐life), while following a self‐management algorithm that included a 30% reduction of post‐exercise evening meal insulin. Data were collected by continuous glucose monitoring for episodes of interstitial glucose <4.0 mmol/L at two‐hourly time‐points for 12 hours post‐exercise.Before the evening meal, the mean blood glucose concentrations were: laboratory 8.0 ± 1.9 mmol/L and real‐life 9.9 ± 4.1 mmol/L. During 2–6 hours after exercise, episodes of glucose concentrations <4.0 mmol/L were: laboratory n = 5, and real‐life n = 2. This compared to 8–12 hours after: laboratory n = 3, and real‐life n = 8. Hypoglycaemia unawareness was noted in eight of all 18 post‐evening meal episodes of <4.0 mmol/L (laboratory n = 5, real‐life n = 3).Despite post‐exercise fast‐acting insulin dose reduction of 30%, delayed hypoglycaemia occurred in both environments with an increase during 8–12 hours in the real‐life environment. Recommendations from data suggest carbohydrate consumption at bedtime, and evening exercisers to perform blood glucose monitoring 8–12 hours post‐exercise. Copyright © 2015 John Wiley & Sons.

G480(P) Carbohydrate counting from diagnosis: is it practical, acceptable and effective?

Background Carbohydrate counting has become a principal strategy for children with type1 diabetes. Precision with carbohydrate counting are associated with lower HbA1C in children with type 1 diabetes (Mehta, 2009). Traditionally, children were not taught this during their first presentation with diabetes. In Gloucester and our network, carbohydrate counting is being taught from diagnosis to embed this practice early. Aims With regards early carbohydrate counting education, we asked: is it practical? is it acceptable to families? is it effective? Methods We compared two 12 month time periods 1/3/12–28/2/13 (education delayed) and 1/3/13–28/2/14 (education early). A sample of 15 patients from both years had their notes and biochemistry results examined. A questionnaire about patient’s experience of early carbohydrate counting was sent. Results Comparing the two time periods (delayed vs. early); the mean age at diagnosis was 9.07 vs. 9.33 years, 36% vs. 47% of patients presented in DKA. The majority started on basal bolus regime but 14% vs. 7% of patients were started on a pump during first admission. There was no significant difference in length of stay (4.21 vs. 5.13 days, p = 0.056). Falls in HbA1C appear sustained across the early education group. 81% learnt CHO counting within a week, 64% preferred to learn CHO counting in hospital and 100% found the education useful. Conclusion Early education about carbohydrate counting appears both practical and effective. There was no increase in length of stay between the two groups. There was generally positive feedback from those families that had early CHO counting education.

Clinical outcomes of adult inpatients treated with continuous subcutaneous insulin infusion for diabetes mellitus: a systematic review.

To provide a systematic review of the current evidence concerning the diabetes-related outcomes of patients provided with continuous subcutaneous insulin infusion for treating diabetes mellitus while a hospital inpatient. Relevant publications were obtained from MEDLINE and EMBASE databases concerning hospital inpatients with diabetes being treated with continuous subcutaneous insulin infusion. Studies were assessed independently by two reviewers, and data on the following outcomes were extracted: inpatient mortality; clinical complications, e.g. diabetic ketoacidosis; hyperglycaemia; hypoglycaemia; length of hospital stay; mean bedside glucose level; and glucose level on discharge. Obstetric cases were examined separately to look at maternal and neonatal glycaemic outcomes. A total of 11 studies met the required criteria and were analysed in detail, 5 of which were predominantly obstetric. No significant complications were reported, with no incidences of death, ketoacidosis or severe hypoglycaemia. Length of hospital stay appeared to be shorter in those patients who remained on continuous subcutaneous insulin infusion, while data on mild hyperglycaemia and hypoglycaemia were inconclusive. There are limited data available to form a significant conclusion about the safety of continuous subcutaneous insulin infusion continuation in hospital; however, its use can be justified with the presence of a specialized inpatient diabetes team for advice and support and an alternative treatment regime (e.g. subcutaneous basal bolus) should be accessible if the need were to arise.

The design and evaluation of a self‐management algorithm for people with type 1 diabetes performing moderate intensity exercise

AbstractLimited evidence is available to advise people with type 1 diabetes about self‐management strategies for maintaining acceptable glycaemic control when exercising.A systematic review was conducted to design a self‐management algorithm for moderate intensity exercise. The effectiveness was investigated regarding the attainment of acceptable glucose concentrations during and after 40 minutes of exercise at 70% VO2 max in the real‐life environment.Nine individuals with type 1 diabetes (five male, four female) completed the study over a two‐week period. All used a basal bolus analogue insulin regimen and exercised regularly. Participants undertook 40 minutes of moderate intensity exercise on days 1 and 8 in real‐life environments, and followed the self‐management algorithm. Data were collected for glucose concentrations at 10 time‐points, i.e. before, during and after exercise.Analysis showed that during the whole time‐period, 56% of participant episodes were in the acceptable glucose range of 4–9 mmol/L, and 39% were above 9 mmol/L. In relation to hypoglycaemic episodes, one episode occurred during exercise, and eight episodes occurred during 8–12 hours after exercise.Despite post‐exercise insulin reduction, nocturnal hypoglycaemia occurred and algorithm adjustments are required regarding carbohydrate consumption at bedtime for future prevention. An addition to the current self‐management algorithm would be to perform blood glucose monitoring 8–12 hours after post‐exercise insulin and meal. Copyright © 2015 John Wiley & Sons, Ltd.

Efficacy of a basal bolus insulin protocol to treat prednisolone-induced hyperglycaemia in hospitalised patients.

Few studies have specifically investigated treatment of prednisolone-induced hyperglycaemia. To determine if a basal bolus insulin (BBI) protocol for inpatient hyperglycaemia is effective in patients prescribed acute prednisolone for an inflammatory disease. In a cross-sectional study, 66 patients with type 2 diabetes admitted to a general medical ward and treated with BBI for up to 5 days were studied. Twenty-four patients were taking prednisolone ≥10 mg/day to treat an acute inflammatory disease. The remaining 42 patients were a control group. The primary outcome was mean daily blood glucose level. There were no significant differences in glycosylated haemoglobin (8.1 ± 1.0 vs 8.1 ± 1.6%, P = 0.88), age (77 ± 11 vs 75 ± 14 years, P = 0.57), male sex (63 vs 60%, P = 0.81) or body mass index (30.0 ± 5.3 vs 30.2 ± 11.5 kg/m(2) , P = 0.90) between patients taking prednisolone and controls. Mean daily glucose concentration was higher in patients taking prednisolone than in controls (12.2 ± 0.3 vs 10.0 ± 0.1 mmol/L, P < 0.001). Blood glucose level was higher in patients on prednisolone at 1700 h (14.6 ± 0.6 vs 10.3 ± 0.3 mmol/L, P < 0.001) and 2100 h (14.5 ± 0.6 vs 10.5 ± 0.3 mmol/L, P < 0.001), with no significant differences at 0700 h and 1200 h. These findings occurred despite patients taking prednisolone receiving a higher daily insulin dose than controls (0.67-0.70 vs 0.61-0.65 U/kg, P = 0.001) because of higher doses of ultra-rapid-acting insulin at 1200 h and 1700 h. Hospitalised patients taking prednisolone had substantial afternoon and evening hyperglycaemia despite receiving BBI via a protocol for inpatient hyperglycaemia. Specific insulin regimens for prednisolone-induced hyperglycaemia are needed that recommend more insulin during this time period.

Clinical use and efficacy of biphasic insulin lispro 50/50 in people with insulin treated diabetes – a nationwide evaluation of clinical practice

Objectives:This study aims to investigate the metabolic effects of biphasic insulin lispro 50/50 in routine clinical practice. A total of 229 patients who were ≥18 years old with diabetes, newly treated with biphasic insulin lispro 50/50, were sourced from six secondary care services in England.Methods:Detailed clinical parameters were compared at baseline, and 3 and 6 months post-initiation. Responders was defined as those with HbA1c <7.5% (58 mmol/mol) and/or an HbA1c reduction of >1% (11 mmol/mol) at 6 months.Results:HbA1c showed significant reduction: −0.93% (−10 mmol/mol) and −1.2% (−13 mmol/mol) at 3 and 6 months respectively, while no significant change was noted for all the other parameters. When analyzed according to frequencies of injections/day, the greatest reduction was observed with the three times a day regimen (−1.0% [−11.0 mmol/mol] and −1.3% [−14.6 mmol/mol] at 3 and 6 months respectively). HbA1c reduction was greatest in the group who previously received a basal–bolus insulin regimen: (−0.8% [−9.0 mmol/mol] and −1.5% [−16.2 mmol/mol] at 3 and 6 months respectively). Reduction in weight was observed at 3 months (−1.8 kg ± 4.3) only for those who were previously on a basal–bolus insulin regimen. Insulin doses increased following conversion to biphasic insulin lispro 50/50, irrespective of the types of insulin used prior to biphasic insulin lispro 50/50, but this was not associated with weight gain. The independent predictors of response to biphasic insulin lispro 50/50 were baseline HbA1c, Caucasian, presence of nephropathy, prior use of basal–bolus insulin and prior use of other premixed combination.Conclusion:Biphasic insulin lispro 50/50 is therefore an effective therapeutic option for achieving glycemic control in patients with suboptimal HbA1c levels, especially among those who were previously on a basal–bolus insulin regimen and those who received it three times daily, with a neutral effect on weight parameters.Limitations:This was a retrospective study of routine clinical practice and is therefore limited by allocation bias and some missing data. Information on rates of hypoglycemia and quality of life are not available.

Trials and tribulations of managing type 1 diabetes.

Effective type 1 diabetes mellitus (T1DM) management tools are education, empowerment, insulin, and diet control. Exercise should be of moderate intensity so as to avoid hypoglycaemia. It is prudent to ensure that the required insulin levels are achieved in all children in order to manage the disorder well. The total daily dose of insulin may be 0.6–1.0 u/kg body weight, and it may be 2/3, 1/3 for split mixed insulin, and 50/50 for multiple subcutaneous injections. The dosages for the pump also vary from child to child. Basal bolus regimen is important and necessary in all T1DM children. It is not necessary to use all types of insulin analogs in all T1DM children, and the decision should depend on cost and delivery limiting factors. The advantages of using analogues are that some of these exhibit low hypoglycemic events (especially nocturnal events with basal insulin) and a few offer flexibility of administration to patients (most prandial analogs and some basal analogs).

Hyperglycemia in the Intensive Care Unit

E-mail: rainer.lenhardt@louisville.edu Phone: +90 001 502-852-5851 SUMMARY Hyperglycemia is frequently encountered in the intensive care unit. In this disease, after severe injury and during diabetes mellitus homeostasis is impaired; hyperglycemia, hypoglycemia and glycemic variability may ensue. These three states have been shown to independently increase mortality and morbidity. Patients with diabetics admitted to the intensive care unit tolerate higher blood glucose values without increase of mortality. Stress hyperglycemia may occur in patients with or without diabetes and has a strong association with increased mortality in the intensive care unit patients. Insulin is the drug of choice to treat hyperglycemia in the intensive care unit. In patients with moderate hyperglycemia a basal–bolus insulin concept can be used. Close glucose monitoring is of paramount importance throughout the intensive care unit stay of the patient. In the guidelines for glycemic control based on meta-analyses it was shown that a tight glycemic control does not have a significant mortality advantage over conventional treatment. Given the controversy about optimal blood glucose goals in the intensive care unit setting, it seems reasonable to target a blood glucose level around 140 mg/dL to avoid episodes of hypoglycemia and minimize glycemic variability. The closed loop system with continuous glucose monitoring and algorithm based insulin application by an infusion pump is a promising new concept with the potential to further reduce mortality and morbidity due to hyperglycemia, hypoglycemia and glycemic variability. The goal of this review was to give a brief overview about pathophysiology of hyperglycemia and to summarize current guidelines for glycemic control in critically ill patients.

Similar glucose control with basal–bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification

ObjectiveThis study aimed to demonstrate the non-inferiority of 50-week treatment with stepwise insulin intensification of basal–bolus insulin analogues [insulin detemir (IDet) and aspart (IAsp)] versus biphasic insulin aspart 30 (BIAsp30) in insulin-naive type 2 diabetes mellitus (T2DM) patients not controlled by oral glucose-lowering drugs (OGLDs). Research design and methodsIn this open-label multicentre, multinational, randomized, parallel-arm treat-to-target trial, 403 insulin-naive patients with T2DM in four African countries were randomized to either an IDet+IAsp (n=200) or BIAsp1-2-3 (n=203) treatment group. Stepwise insulin intensification was performed at the end of 14, 26 and 38 weeks, depending on HbA1c values. The primary endpoint was change in HbA1c after 50 weeks of treatment. Safety variables were hypoglycaemia incidence, occurrence of adverse events and weight gain. ResultsNon-inferiority of the IDet+IAsp versus BIAsp1-2-3 treatment regimen was demonstrated by their similar HbA1c levels at the end of trial (IDet+IAsp: baseline 8.6%, 50 weeks 7.4%; BIAsp1-2-3: baseline 8.7%, 50 weeks 7.3%; full analysis set difference: 0.1% [95% CI: −0.1, 0.3]; per protocol: 0.2% [95% CI: −0.1, 0.4]). At week 50, 40.3 and 44.9% of patients achieved HbA1c <7.0% with IDet+IAsp and BIAsp1-2-3, respectively. The rate of overall hypoglycaemia during the trial was also similar in both groups (IDet+IAsp: 9.4 events/patient-year; BIAsp1-2-3: 9.8 events/patient-year). ConclusionInsulin initiation and intensification using IDet+IAsp was not inferior to BIAsp1-2-3 in insulin-naive patients with T2DM not controlled by OGLDs. Both regimens led to similar reductions in HbA1c values after 50 weeks of treatment.

PO083 PRACTICAL GUIDANCE ON THE USE OF PREMIX INSULIN ANALOGUES FOR INITIATING, INTENSIFYING OR SWITCHING INSULIN REGIMENS IN TYPE 2 DIABETES

Introduction Premix insulin analogs are a well-established treatment for type 2 diabetes (T2D). However, there is a lack of simple, clear guidance on some aspects of their use. These include choosing a regimen for insulin initiation, recognizing when patients need intensification of therapy, and switching from basal–bolus to a premix insulin analog when appropriate.

Safe and effective dosing of basal-bolus insulin in patients receiving high-dose steroids for hyper-cyclophosphamide, doxorubicin, vincristine, and dexamethasone chemotherapy.

Hyperglycemia occurs in cancer patients receiving high-dose steroids with cyclophosphamide, doxorubicin, vincristine, and dexamethasone (hyper-CVAD) protocol. The purpose of our study was to determine insulin requirements in patients with hyperglycemia on hyper-CVAD therapy using a systematic algorithm. We did a retrospective chart review of 23 leukemia inpatients with hyperglycemia (two glucose values >250 mg/dL) on hyper-CVAD chemotherapy managed by the Endocrine Diabetes Inpatient Team algorithm. We reviewed demographic and glycemic data, insulin dosages, and use of oral hypoglycemic agents. Using our algorithm, the dose of insulin for each patient was titrated daily and with each subsequent cycle of hyper-CVAD. Ninety-one percent of patients had known diabetes. The median body mass index was 32.5 (range, 21.6-40.9) kg/m², and median age was 61 (range, 40-80) years. The overall trend in glucose values across cycles showed a statistically significant decrease with each subsequent cycle of hyper-CVAD. Hyperglycemia accounted for 81% of glucose measurements in the first cycle and 60% of glucose values in the last cycle. Patients received 1-1.3 units/kg of insulin per cycle, and insulin requirements were similar across cycles. The distribution of basal versus bolus insulin for each cycle was 63-77% prandial and 23-37% basal. Nine of the 23 patients had at least one glucose value <70 mg/dL, which accounted for 1.3% of all recorded glucose values. None of the patients had severe hypoglycemia. Multiple-dose insulin therapy initiated at 1-1.2 units/kg/day, distributed as 25% basal and 75% prandial, reduced hyperglycemia in patients who were receiving high-dose dexamethasone as part of hyper-CVAD.

Hospital discharge algorithm based on admission HbA1c for the management of patients with type 2 diabetes.

Effective treatment algorithms are needed to guide diabetes care at hospital discharge in general medicine and surgery patients with type 2 diabetes. This was a prospective, multicenter open-label study aimed to determine the safety and efficacy of a hospital discharge algorithm based on admission HbA1c. Patients with HbA1c <7% (53.0 mmol/mol) were discharged on their preadmission diabetes therapy, HbA1c between 7 and 9% (53.0-74.9 mmol/mol) were discharged on a preadmission regimen plus glargine at 50% of hospital daily dose, and HbA1c >9% were discharged on oral antidiabetes agents (OADs) plus glargine or basal bolus regimen at 80% of inpatient dose. The primary outcome was HbA1c concentration at 12 weeks after hospital discharge. A total of 224 patients were discharged on OAD (36%), combination of OAD and glargine (27%), basal bolus (24%), glargine alone (9%), and diet (4%). The admission HbA1c was 8.7 ± 2.5% (71.6 mmol/mol) and decreased to 7.3 ± 1.5% (56 mmol/mol) at 12 weeks of follow-up (P < 0.001). The change of HbA1c from baseline at 12 weeks after discharge was -0.1 ± 0.6, -0.8 ± 1.0, and -3.2 ± 2.4 in patients with HbA1c <7%, 7-9%, and >9%, respectively (P < 0.001). Hypoglycemia (<70 mg/dL) was reported in 22% of patients discharged on OAD only, 30% on OAD plus glargine, 44% on basal bolus, and 25% on glargine alone and was similar in patients with admission HbA1c ≤7% (26%) compared with those with HbA1c >7% (31%, P = 0.54). Measurement of HbA1c on admission is beneficial in tailoring treatment regimens at discharge in general medicine and surgery patients with type 2 diabetes.

PO-0955 Closing The Loop – Successful Implementation Of Audit Recommendations In A Regional Diabetes Centre

Background A previous audit was performed in 2011 by the Paediatric Diabetes department in Sligo Regional Hospital which examined practices, results and key care processes at annual review and compared them to International Standards (1,2). This resulted in several recommendations aimed to improve metabolic control within the cohort. Objectives The objectives of this audit were to compare HbA1c levels in 2013 to those in 2011 and to International Standards (3,4,5), to investigate if the previous recommendations had been implemented and to investigate the proportion of patients with secondary complications. Methods All paediatric patients with diabetes who had an annual review scheduled during 2013 in our centre were included. Exclusion criteria were those who had annual review scheduled at a tertiary centre. Data were collated from retrospective chart review. Results In our cohort of 50 patients, HbA1c results reflected significant improvement from 2011 levels (see Graph 1). The complication rate was found to be comparable to International Standards (5,6) (see Table 1). There was no improvement in the key care processes performed (see Table 2). Conclusion Our improved HbA1c results reflect the increased frequency of appointments and use of basal bolus regimes. References 1 NICE 2009 2 NPDA 2009–2010 3 NPDA 2011–2012 4 IDF/ISPAD 2011 Global Guideline for diabetes in childhood and adolescence 5 Maike C et al . Prevalence of diabetes complications in adolescents with type 2 compared with Type 1 Diabetes . 6 Downie E et al . Continued reduction in the Prevalance of retinopathy in adolescents with type 1 diabetes. Diabetes care , 2011;34