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What Is Basal Plus Insulin Regimen?

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes: Basal Plus Trial

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes: Basal Plus Trial

Abstract OBJECTIVE Effective and easily implemented insulin regimens are needed to facilitate hospital glycemic control in general medical and surgical patients with type 2 diabetes (T2D).RESEARCH DESIGN AND METHODS This multicenter trial randomized 375 patients with T2D treated with diet, oral antidiabetic agents, or low-dose insulin (≤0.4 units/kg/day) to receive a basal bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI).RESULTSImprovement in mean daily blood glucose (BG) after the first day of therapy was similar between basal bolus and basal plus groups (P = 0.16), and both regimens resulted in a lower mean daily BG than did SSI (P = 0.04). In addition, treatment with basal bolus and basal plus regimens resulted in less treatment failure (defined as >2 consecutive BG >240 mg/dL or a mean daily BG >240 mg/dL) than did treatment with SSI (0 vs. 2 vs. 19%, respectively; P < 0.001). A BG <70 mg/dL occurred in 16% of patients in the basal bolus group, 13% in the basal plus group, and 3% in the SSI group (P = 0.02). There was no difference among the groups in the frequency of severe hypoglycemia (<40 mg/dL; P = 0.76).CONCLUSIONS The use of a basal plus regimen with glargine once daily plus corrective doses with glulisine insulin before meals resulted in glycemic control similar to a standard basal bolus regimen. The basal plus approach is an effective alternative to the use of a basal bolus regimen in general medical and surgical patients with T2D. Continue reading >>

Review Of Basal-plus Insulin Regimen Options For Simpler Insulin Intensification In People With Type 2 Diabetes Mellitus.

Review Of Basal-plus Insulin Regimen Options For Simpler Insulin Intensification In People With Type 2 Diabetes Mellitus.

Abstract AIMS: To identify simple insulin regimens for people with Type 2 diabetes mellitus that can be accepted and implemented earlier in primary and specialist care, taking into consideration each individual's needs and capabilities. METHODS: Using randomized clinical trials identified by a search of the PubMed database, as well as systematic reviews, meta-analyses and proof-of-concept studies, this review addresses topics of interest related to the progressive intensification of a basal insulin regimen to a basal-plus regimen (one basal insulin injection plus stepwise addition of one to three preprandial short-acting insulin injections/day) vs a basal-bolus regimen (basal insulin plus three short-acting insulin injections per day) in people with Type 2 diabetes. The review explores approaches that can be used to define the meal for first prandial injection with basal-plus regimens, differences among insulin titration algorithms, and the importance of self-motivation and autonomy in achieving optimum glycaemic control. RESULTS: A basal-plus regimen can provide glycaemic control equivalent to that obtained with a full basal-bolus regimen, with fewer injections of prandial insulin. The first critical step is to optimize basal insulin dosing to reach a fasting glucose concentration of ~6.7 mmol/l; this allows ~40% of patients with baseline HbA1c >75 mmol/mol (9%) to be controlled with only one basal insulin injection per day. CONCLUSIONS: Compared with a basal-bolus regimen, a basal-plus insulin regimen is as effective but more practical, and has the best chance of acceptance and success in the real world. © 2017 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. Continue reading >>

Examples Of Insulin Initiation And Titration Regimens In People With Type 2 Diabetes

Examples Of Insulin Initiation And Titration Regimens In People With Type 2 Diabetes

Appendix 3 All people starting insulin should be counseled about the recognition, prevention and treatment of hypoglycemia. Consider a change in type or timing of insulin administration if glycemic targets are not being reached. Example A: Basal insulin (Humulin®-N, Lantus®, Levemir®, Novolin®ge NPH) added to oral antihyperglycemic agents • Insulin should be titrated to achieve target fasting BG levels of 4.0 to 7.0 mmol/L. • Individuals can be taught self-titration, or titration may be done in conjunction with a healthcare provider. • Suggested starting dose is 10 units once daily at bedtime. • Suggested titration is 1 unit per day until target is reached. • A lower starting dose, slower titration and higher targets may be considered for elderly or normal weight subjects. • In order to safely titrate insulin, patients must perform SMBG at least once a day fasting. • Insulin dose should not be increased if the individual experiences 2 episodes of hypoglycemia (BG <4.0 mmol/L) in 1 week or any episode of nocturnal hypoglycemia. • For fasting BG levels consistently <5.5 mmol/L, a reduction of 1 to 2 units of insulin may be considered to avoid nocturnal hypoglycemia. • Oral antihyperglycemic agents (especially secretagogues) may need to be reduced if daytime hypoglycemia occurs. Example B: Basal Plus Strategy - Adding bolus (prandial) insulin (Apidra®, Humalog®, NovoRapid®) once daily to optimized basal insulin therapy • When intensification of insulin therapy is necessary, start one injection of meal time insulin to either main meal or breakfast. • Starting dose is 2 to 4 units and patient can be taught self titration or dose increase can be done by HCP. • To safely increase dose, glucose levels should be measured at least prior to insulin d Continue reading >>

Important Safety Information For Apidra® (insulin Glulisine [rdna Origin] Injection)

Important Safety Information For Apidra® (insulin Glulisine [rdna Origin] Injection)

Increased A1C and BG Control In the OPAL study, the Apidra® Basal-Plus 1 regimen helped patients reach A1C goal1 Treatment equivalence of both breakfast and main meal Apidra® regimens was demonstrated Adding 1 dose of Apidra® a day to Lantus® (insulin glargine injection) and OADs resulted in significant A1C reductions from baseline to endpoint: breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94%1 Improvements in BG control were significant in both breakfast and main meal groups1 Improved 8-pt BG profiles for breakfast and main meal groupsa In the breakfast arm, improved BG levels also extended to the prelunch period1 Safety Results a Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia during which the person required the assistance of another person which was associated with blood glucose level below 36 mg/dL (2.0 mmol/l) and/or an administration of oral carbohydrate, intravenous glucose or glucagons.2 b P=NS. c Evaluated for safety. Study Design1,2 24-week, multicenter, parallel, open-label, 1:1 randomized study comparing the efficacy of Apidra® administered at breakfast or the main meal in 316 patients ≥18 years with type 2 diabetes who were previously uncontrolled on Lantus® (insulin glargine injection) and OADs and whose A1C was >6.5% and <9%. At the end of the screening phase, 316 patients with FBG ≤120mg/dL were randomized and administered 1 injection of Apidra® at either breakfast (n=162) or main mealtime (n=154). The dosage was individually titrated at the investigator’s discretion to the target goals of 2h PPG ≤135 mg/dL and FBG ≤100 mg/dL in the absence of hypoglycemia. Next Page Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabet Continue reading >>

Review Of Basal-plus Insulin Regimen Options For Simpler Insulin Intensification In People With Type 2 Diabetes Mellitus

Review Of Basal-plus Insulin Regimen Options For Simpler Insulin Intensification In People With Type 2 Diabetes Mellitus

Artificial pancreas is a long awaited dream for generations of endocrinologists. Technological advances made closed loop systems a reality and the dream comes closer. Hybrid closed-loop (HCL) Insulin Delivery Systems use various combinations of control algorithms, glucose sensors data, and insulin pumps to automatically and safely increase, decrease, and suspend insulin delivery. In a pivotal trial, Minimed 670G HCL system was investigated with sufficient number of participants and a duration of three months to demonstrate its safety and effectiveness. This single-arm study was performed in a multicentre setup in 10 sites (9 diabetes centres in the United States and one in Israel). The primary endpoint of the study was safety of HCL system use. 124 participants thereof 30 adolescents and 94 adults with Type 1 diabetes for more than 2 years using Insulin pumps with or without continuous glucose monitoring for more than 6 months have been included in this study. There was a 2-week in-home period (run-in phase), in which subjects used the system in Manual Mode followed by a 3-month in-home study phase in which Auto Mode was enabled. The HCL algorithm included a high alert setting of 300mg/dL and low alert setting of 70mg/dL. Several alarms were set for rapid value decrease. Target was fixed at 120mg/dL. Participants had to calibrate the sensors, 3-4 times a day, enter carbohydrate for meal boluses and perform finger prick BG values for correction insulin boluses. HCL system could be stopped by users any time. Previous results already reported by Bergenstal RM, Garg S, Weinzimmer SA et al. proved that adolescents and adults with Type 1 Diabetes in an outpatient setting could use this HCL system safely. No episode of severe hypoglycaemia or diabetic acidosis was reported in Continue reading >>

“basal Plus” Insulin Achieves Outcomes Similar To Those Of Basal Bolus Therapy

“basal Plus” Insulin Achieves Outcomes Similar To Those Of Basal Bolus Therapy

This article requires a subscription for full access. NEJM Journal Watch articles published within the last six months are available to subscribers only. Articles published more than 6 months ago are available to registered users. Continue reading >>

Initiation And Intensification Strategies In Type 2 Diabetes Management: A Comparison Of Basal Plus And Premix Regimens

Initiation And Intensification Strategies In Type 2 Diabetes Management: A Comparison Of Basal Plus And Premix Regimens

Abstract The progressive nature of type 2 diabetes (T2D) often results in the need for initiation and subsequent intensification of insulin treatment to achieve glycemic control. The aim of this review is to examine published clinical evidence that has directly compared two recommended treatment approaches in patients with T2D: (1) a ‘basal plus’ regimen, whereby 1–2 injections of prandial insulin are added to basal insulin; or (2) the use of once- or twice-daily premix insulin analogs, which contain both basal and prandial insulin in a single injection. Broadly, the available evidence suggests that both basal plus and premix regimens are comparable in terms of efficacy and safety when used for insulin initiation in insulin-naïve patients and intensification in patients who have failed on basal insulin; instances of greater glycemic control are observed with premix insulin; however, these are often accompanied by increases in hypoglycemia and/or weight relative to basal plus treatment, and results should be interpreted within the context of total insulin doses used. Relatively low numbers of patients achieved glycemic control when both regimens were used for insulin intensification following failure of basal insulin, suggesting that a full basal–bolus regimen and/or the use of different treatments is clinically indicated in certain patients. In summary, the current review argues that both basal plus and premix insulin regimens are relatively efficacious and safe options for patients with T2D during both insulin initiation in insulin-naïve patients and intensification in patients who have failed on basal insulin. This emphasizes the important role of patient-centered factors in clinical decision-making. Funding: Novo Nordisk. Notes Sponsorship and article proce Continue reading >>

Get Unlimited Access On Medscape.

Get Unlimited Access On Medscape.

WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide, one of the components of Xultophy® 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Xultophy® 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Xultophy® 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Xultophy® 100/3.6 and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Xultophy® 100/3.6. Xultophy® 100/3.6 has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Xultophy® 100/3.6 promptly and if pancreatitis is confirmed, do not restart. Consider other antidiabetic therapies in patients with a history of pancreatitis. Overdose Due to Medication Errors: Instruct patients to check the label before each injection sin Continue reading >>

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes

OBJECTIVE Effective and easily implemented insulin regimens are needed to facilitate hospital glycemic control in general medical and surgical patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This multicenter trial randomized 375 patients with T2D treated with diet, oral antidiabetic agents, or low-dose insulin (≤0.4 units/kg/day) to receive a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI). RESULTS Improvement in mean daily blood glucose (BG) after the first day of therapy was similar between basal-bolus and basal plus groups (P = 0.16), and both regimens resulted in a lower mean daily BG than did SSI (P = 0.04). In addition, treatment with basal-bolus and basal plus regimens resulted in less treatment failure (defined as >2 consecutive BG >240 mg/dL or a mean daily BG >240 mg/dL) than did treatment with SSI (0 vs. 2 vs. 19%, respectively; P < 0.001). A BG <70 mg/dL occurred in 16% of patients in the basal-bolus group, 13% in the basal plus group, and 3% in the SSI group (P = 0.02). There was no difference among the groups in the frequency of severe hypoglycemia (<40 mg/dL; P = 0.76). CONCLUSIONS The use of a basal plus regimen with glargine once daily plus corrective doses with glulisine insulin before meals resulted in glycemic control similar to a standard basal-bolus regimen. The basal plus approach is an effective alternative to the use of a basal-bolus regimen in general medical and surgical patients with T2D. Inpatient hyperglycemia in patients, with or without diabetes, is associated with poor hospital outcomes, including prolonged hospital stay, infections, and disability after hospital discharge, Continue reading >>

Use Of A Basal-plus Insulin Regimen In Persons With Type 2 Diabetes Stratified By Age And Body Mass Index: A Pooled Analysis Of Four Clinical Trials

Use Of A Basal-plus Insulin Regimen In Persons With Type 2 Diabetes Stratified By Age And Body Mass Index: A Pooled Analysis Of Four Clinical Trials

Abstract Aims To evaluate the efficacy and safety of adding a single bolus dose of insulin glulisine to basal insulin (‘basal-plus’) in persons with type 2 diabetes. Methods Data from patients with poor glycemic control on oral antihyperglycemic drugs who were initiated on a ‘basal-plus’ regimen for up to 6 months were pooled from four randomized, multicenter studies. Glycated hemoglobin (HbA1c), fasting blood glucose, postprandial glucose (PPG), insulin dose and demographics were measured at baseline and end of study. Results 711 patients with a mean age of 59.9 years and a mean duration of diabetes of 11.0 years were included in the analysis population. A ‘basal-plus’ regimen was associated with significant decreases in HbA1c and PPG at 6 months, an increase in glargine and glulisine doses and small, but statistically significant, changes in body weight and BMI in all patient subsets. The proportion of patients with HbA1c < 7% also increased in all populations studied, while the prevalence of severe hypoglycemia was low and did not significantly differ across patient groups. Conclusions These results suggest that the use of ‘basal-plus’ can achieve a good therapeutic response with a low risk of hypoglycemia and weight gain, regardless of a patient's age or BMI. Continue reading >>

Use Of A Basal-plus Insulin Regimen In Persons With Type 2 Diabetes Stratified By Age And Body Mass Index: A Pooled Analysis Of Four Clinical Trials.

Use Of A Basal-plus Insulin Regimen In Persons With Type 2 Diabetes Stratified By Age And Body Mass Index: A Pooled Analysis Of Four Clinical Trials.

Abstract AIMS: To evaluate the efficacy and safety of adding a single bolus dose of insulin glulisine to basal insulin ('basal-plus') in persons with type 2 diabetes. METHODS: Data from patients with poor glycemic control on oral antihyperglycemic drugs who were initiated on a 'basal-plus' regimen for up to 6 months were pooled from four randomized, multicenter studies. Glycated hemoglobin (HbA1c), fasting blood glucose, postprandial glucose (PPG), insulin dose and demographics were measured at baseline and end of study. RESULTS: 711 patients with a mean age of 59.9 years and a mean duration of diabetes of 11.0 years were included in the analysis population. A 'basal-plus' regimen was associated with significant decreases in HbA1c and PPG at 6 months, an increase in glargine and glulisine doses and small, but statistically significant, changes in body weight and BMI in all patient subsets. The proportion of patients with HbA1c<7% also increased in all populations studied, while the prevalence of severe hypoglycemia was low and did not significantly differ across patient groups. CONCLUSIONS: These results suggest that the use of 'basal-plus' can achieve a good therapeutic response with a low risk of hypoglycemia and weight gain, regardless of a patient's age or BMI. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved. Continue reading >>

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes

Randomized Study Comparing A Basal-bolus With A Basal Plus Correction Insulin Regimen For The Hospital Management Of Medical And Surgical Patients With Type 2 Diabetes

Author Notes: G.E.U. wrote the initial research proposal and manuscript and collected and researched data. D.S., A.K., D.E.O., C.N., S.J., M.R., L.P., A.G., and V.A.F. reviewed and edited the research proposal and manuscript and contributed to the discussion. K.H. reviewed and edited the research proposal and manuscript, contributed to the discussion, and collected and researched data. D.R., I.P., M.E.F., V.H., and M.T.T. collected and researched data. G.E.U. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Parts of this study were presented in abstract form at the 72nd Scientific Sessions of the American Diabetes Association, Philadelphia, Pennsylvania, 8–12 June 2012. No other potential conflicts of interest relevant to this article were reported. Subjects: Research Funding: G.E.U. is supported in part by research grants from the American Diabetes Association (7-03-CR-35) and by PHS Grant UL1 RR025008 from the Clinical and Translational Science Award program, National Institutes of Health, National Center for Research Resources. This investigator-initiated study was supported by an unrestricted grant from Sanofi (Bridgewater, NJ). The sponsors of the study were not involved in the study design, data collection, analysis or interpretation of the results, or preparation of the manuscript. Keywords: Continue reading >>

Basal Bolus - Basal Bolus Injection Regimen

Basal Bolus - Basal Bolus Injection Regimen

Tweet A basal-bolus injection regimen involves taking a number of injections through the day. A basal-bolus regimen, which includes an injection at each meal, attempts to roughly emulate how a non-diabetic person’s body delivers insulin. A basal-bolus regimen may be applicable to people with type 1 and type 2 diabetes. What is a basal-bolus insulin regimen? A basal-bolus routine involves taking a longer acting form of insulin to keep blood glucose levels stable through periods of fasting and separate injections of shorter acting insulin to prevent rises in blood glucose levels resulting from meals. What is basal insulin? The role of basal insulin, also known as background insulin, is to keep blood glucose levels at consistent levels during periods of fasting. When fasting, the body steadily releases glucose into the blood to our cells supplied with energy. Basal insulin is therefore needed to keep blood glucose levels under control, and to allow the cells to take in glucose for energy. Basal insulin is usually taken once or twice a day depending on the insulin. Basal insulin need to act over a relatively long period of time and therefore basal insulin will either be long acting insulin or intermediate insulin. What is bolus insulin? A bolus dose is insulin that is specifically taken at meal times to keep blood glucose levels under control following a meal. Bolus insulin needs to act quickly and so short acting insulin or rapid acting insulin will be used. Bolus insulin is often taken before meals but some people may be advised to take their insulin during or just after a meal if hypoglycemia needs to be prevented. Your doctor will be able to advise you if you have any questions as to when your bolus insulin should be taken. Advantages of a basal-bolus regimen One of t Continue reading >>

Comparison Of A Basal Plus One Insulin Regimen With A Biphasic Insulin Regimen In Type 2 Diabetes Patients (lanscape)

Comparison Of A Basal Plus One Insulin Regimen With A Biphasic Insulin Regimen In Type 2 Diabetes Patients (lanscape)

The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes. The secondary objective are: To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period To compare the rates of hypoglycaemia (total, severe, nocturnal) To compare the change in body weight from visit 10 to visit 24 To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24 Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c) Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire Insulin Treatment Satisfaction Questionnaire (ITSQ) EuroQoL 5 Dimensions (EQ5D) questionnaire To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24 Study Type : Interventional (Clinical Trial) Actual Enrollment : 463 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Comparison of a Basal Plus One Insulin Regimen (Insulin Glargine/Insulin Glulisine) With a Biphasic Insulin Regimen (Insulin Aspart/Insulin Aspart Protamine 30/70) in Type 2 Diabetes Patients Following Basal Insulin Optimisation Study Start Date : July 2009 Primary Completion Date : December 2012 Study Completion Date : December 2012 Arm Intervention/treatment Experimental: Lantus + Apidra basal plus one Before randomization (common with arm 2): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy Continue reading >>

Keeping It Simple With Insulin Regimens

Keeping It Simple With Insulin Regimens

Published in the July 2013 issue of Today’s Hospitalist DESPITE MOUNTING EVIDENCE against sliding scale regular insulin, the strategy continues to be widely used for patients with type 2 diabetes who are hospitalized and need to stop their oral diabetes medications. Many physicians seem to find the alternative “basal bolus “too complicated and too difficult. As a result, experts have been trying to figure out a way to make the basal bolus regimen easier. Drawing on the fact that people tend to eat very little while they are hospitalized, researchers have hit on a relatively simple idea: Use only basal insulin and forget about fast-acting boluses unless needed by individual patients experiencing hyperglycemia in the hospital. This regimen is called basal plus correction, or “basal plus” for short. “I believe this is the simpler way,” explains Guillermo Umpierrez, MD, a professor of medicine and director of endocrinology and diabetes at Grady Health System and Emory University in Atlanta. His research, which was published in the Feb. 22, 2013, issue of Diabetes Care, showed that basal plus “resulted in glycemic control similar to a standard basal bolus regimen.” The study also found that both methods produced better results than sliding scale regular insulin. The multicenter trial randomized 375 patients with type 2 diabetes into three groups: One received sliding scale regular insulin. A second received a basal bolus regimen of glargine once daily and regular doses of rapid-acting glulisine before meals. And patients in the basal plus group received glargine once a day and supplemental doses of glulisine only when regular pre-meal blood sugar checks showed they were hyperglycemic. Besides finding that the basal bolus and basal plus regimens controlled t Continue reading >>

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