scholarly journals Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial

2021 ◽  
Author(s):  
Dario Giugliano ◽  
Miriam Longo ◽  
Paola Caruso ◽  
Rosa Di Fraia ◽  
Lorenzo Scappaticcio ◽  
...  
Keyword(s):  
Basal Insulin ◽  
Insulin Dose ◽  
Pragmatic Trial ◽  
Sglt2 Inhibitor ◽  
Fixed Ratio ◽  
Insulin Regimen ◽  
Similar Reduction ◽  
Once Daily ◽  
Bolus Insulin ◽  
Basal Bolus

<b>OBJECTIVE </b> <p><b>BEYOND trial evaluated the feasibility of either basal insulin + GLP-1RA (glucagon-like peptide-1 receptor agonist), or basal insulin + SGLT-2i (sodium-glucose cotransporter-2 inhibitor) to replace a full basal-bolus insulin (BBI) regimen in participants with type 2 diabetes and</b><b> </b><b>inadequate glycemic control. </b></p> <p><b>RESEARCH DESIGN AND METHODS</b> </p> <p><b>Participants were randomized (1:1:1) to: a) intensification of the BBI regimen (n = 101), b) fixed-ratio of basal insulin + GLP-1RA (fixed-combo group, n = 102), and c) combination of basal insulin + SGLT-2i (gliflo-combo group, n = 102). The primary efficacy outcome was change from baseline in HbA1c at 6 months. </b><b></b></p> <p><b>RESULTS</b></p> <p><b>Baseline characteristics were similar among the 3 groups (mean HbA1c was 8.6%, 70 mmol/mol). At 6 months, patients experienced similar reduction in HbA1c level (-0.6 ± 0.8, -0.6 ± 0.8, -0.7 ± 0.9%, mean ± SD, respectively, noninferiority P < 0.001 vs BBI) and the proportion of patients with HbA1c ≤7.5% was also similar (34%, 28% and 27%, respectively, P = 0.489). Total insulin dose increased in BBI group (62 U/day), and decreased both in the fixed-combo and gliflo-combo groups (27 U and 21 U/day, respectively, P <0.01</b><b>). The proportion of patients with hypoglycemia was 17.8%, 7.8% and 5.9%, respectively (P = 0.015). There were 12 drop-outs in the fixed-combo group, 9 in the gliflo-combo group and none in the BBI group. </b><b></b></p> <p><b>CONCLUSIONS</b> </p> <p><b>BEYOND provides evidence that it is possible and safe to switch from a BBI regimen to either a once daily fixed-combo injection or once daily gliflozin added to basal insulin, with similar glucose control, less insulin doses, less injections daily, and less hypoglycemia.</b><b></b></p>

scholarly journals Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial

2021 ◽  
Author(s):  
Dario Giugliano ◽  
Miriam Longo ◽  
Paola Caruso ◽  
Rosa Di Fraia ◽  
Lorenzo Scappaticcio ◽  
...  
Keyword(s):  
Basal Insulin ◽  
Insulin Dose ◽  
Pragmatic Trial ◽  
Sglt2 Inhibitor ◽  
Fixed Ratio ◽  
Insulin Regimen ◽  
Similar Reduction ◽  
Once Daily ◽  
Bolus Insulin ◽  
Basal Bolus

<b>OBJECTIVE </b> <p><b>BEYOND trial evaluated the feasibility of either basal insulin + GLP-1RA (glucagon-like peptide-1 receptor agonist), or basal insulin + SGLT-2i (sodium-glucose cotransporter-2 inhibitor) to replace a full basal-bolus insulin (BBI) regimen in participants with type 2 diabetes and</b><b> </b><b>inadequate glycemic control. </b></p> <p><b>RESEARCH DESIGN AND METHODS</b> </p> <p><b>Participants were randomized (1:1:1) to: a) intensification of the BBI regimen (n = 101), b) fixed-ratio of basal insulin + GLP-1RA (fixed-combo group, n = 102), and c) combination of basal insulin + SGLT-2i (gliflo-combo group, n = 102). The primary efficacy outcome was change from baseline in HbA1c at 6 months. </b><b></b></p> <p><b>RESULTS</b></p> <p><b>Baseline characteristics were similar among the 3 groups (mean HbA1c was 8.6%, 70 mmol/mol). At 6 months, patients experienced similar reduction in HbA1c level (-0.6 ± 0.8, -0.6 ± 0.8, -0.7 ± 0.9%, mean ± SD, respectively, noninferiority P < 0.001 vs BBI) and the proportion of patients with HbA1c ≤7.5% was also similar (34%, 28% and 27%, respectively, P = 0.489). Total insulin dose increased in BBI group (62 U/day), and decreased both in the fixed-combo and gliflo-combo groups (27 U and 21 U/day, respectively, P <0.01</b><b>). The proportion of patients with hypoglycemia was 17.8%, 7.8% and 5.9%, respectively (P = 0.015). There were 12 drop-outs in the fixed-combo group, 9 in the gliflo-combo group and none in the BBI group. </b><b></b></p> <p><b>CONCLUSIONS</b> </p> <p><b>BEYOND provides evidence that it is possible and safe to switch from a BBI regimen to either a once daily fixed-combo injection or once daily gliflozin added to basal insulin, with similar glucose control, less insulin doses, less injections daily, and less hypoglycemia.</b><b></b></p>

scholarly journals Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Yuka Tosaka ◽  
Akio Kanazawa ◽  
Fuki Ikeda ◽  
Mayu Iida ◽  
Junko Sato ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Basal Insulin ◽  
Japanese Patients ◽  
Insulin Degludec ◽  
Insulin Regimen ◽  
Once Daily ◽  
Daily Insulin ◽  
Bolus Insulin ◽  
Basal Bolus

The aim of this study was to investigate the efficacy of insulin degludec used for basal-bolus insulin regimen after switching from twice-daily basal insulin in Japanese patients with type 1 diabetes mellitus. The subjects were 22 type 1 diabetes patients treated with basal-bolus insulin regimen with twice-daily basal insulin. Basal insulin was switched to once-daily injection of insulin degludec with 10% dose reduction. HbA1c and fasting plasma glucose (FPG) were measured before and 12 weeks after switching. The frequency of hypoglycemic episodes, standard deviation (SD) of blood glucose, and mean of daily difference (MODD) were evaluated by continuous glucose monitoring (CGM) before and 4 weeks after switching. HbA1c and FPG before and 12 weeks after switching were comparable (HbA1c 8.5 ± 1.4 versus 8.7 ± 1.6%,P=0.28; FPG 203.2 ± 81.2 versus 206.5 ± 122.4 mg/dL,P=0.91). The frequency of hypoglycemia during nighttime was not significantly different at 4 weeks after switching (14.4 ± 17.0 versus 11.1 ± 15.0%,P=0.45). In addition, SD and MODD before and 4 weeks after switching were also comparable. In conclusion, glycemic control under once-daily insulin degludec injection was almost comparable to that under twice-daily basal insulin injections in Japanese type 1 diabetes patients. This study was registered with ID:UMIN000010474.

scholarly journals Addition of a single short-acting insulin bolus to basal insulin-supported oral therapy: a systematic review of data on the basal-plus regimen

2019 ◽  
Vol 7 (1) ◽  
pp. e000679 ◽  
Author(s):  
Jochen Seufert ◽  
Anja Borck ◽  
Peter Bramlage
Keyword(s):  
Basal Insulin ◽  
Fixed Ratio ◽  
Severe Hypoglycemia ◽  
Insulin Regimen ◽  
Premixed Insulin ◽  
Minimal Impact ◽  
Short Acting ◽  
Acting Insulin ◽  
Short Acting Insulin ◽  
Basal Bolus

We summarize here clinical and trial data on a once-daily administration of a single bolus to the meal with the largest expected postprandial glucose excursion (basal-plus), and comment on its clinical utility in the treatment of type 2 diabetes. A PubMed search of data published until September 2018 was taken into consideration and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Eighteen reports representing 15 studies were identified (age: 18–80 years; 50–890 patients; follow-up: 8 days to 60 weeks). Data suggest basal-plus is efficacious for improving glycemic control, with a low incidence of (severe) hypoglycemia and minor increases in bodyweight. The timing of short-acting insulin administration and use of different monitoring/titration approaches appear to have minimal impact. When compared with premixed insulin, basal-plus results in largely comparable outcomes. Compared with basal-bolus, it may result in non-inferior glycemic improvements with less weight gain, less hypoglycemia and fewer daily injections. A basal insulin/glucagon-like peptide-1 receptor agonist fixed ratio combination may offer several advantages over the basal-plus regimen, at the cost of gastrointestinal side effects. We conclude that the stepwise introduction of short-acting insulin via the basal-plus strategy represents a viable alternative to a full basal-bolus regimen and may help to overcome barriers associated with multiple injections and anticipated complexity of the insulin regimen.

SAFETY AND EFFICACY OF DPP-4 INHIBITORS FOR THE MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES

2020 ◽  
Vol 26 (7) ◽  
pp. 722-728 ◽  
Author(s):  
Cristina Lorenzo-González ◽  
Elena Atienza-Sánchez ◽  
David Reyes-Umpierrez ◽  
Priyathama Vellanki ◽  
Georgia M. Davis ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Basal Insulin ◽  
General Medicine ◽  
Insulin Regimen ◽  
Oral Agents ◽  
Dipeptidyl Peptidase 4 Inhibitors ◽  
Bolus Insulin ◽  
Basal Bolus

Objective: DPP-4 inhibitors (DPP-4i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from 3 prospective studies using DPP-4i in general medicine and surgery patients with type 2 diabetes (T2D). Methods: We combined data from 3 randomized studies comparing DPP-4i alone or in combination with basal insulin or a basal-bolus insulin regimen. Medicine (n = 266) and surgery (n = 319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dL, treated with diet, oral agents, or low-dose insulin therapy were included. Patients received DPP-4i alone (n = 144), DPP-4i plus basal insulin (n = 158) or basal-bolus regimen (n = 283). All groups received correctional doses with rapid-acting insulin for BG >140 mg/dL. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications. Results: There were no differences in mean hospital daily BG among patients treated with DPP-4i alone (170 ± 37 mg/dL), DPP-4i plus basal (172 ± 42 mg/dL), or basalbolus (172 ± 43 mg/dL), P = .94; or in the percentage of BG readings within target of 70 to 180 mg/dL (63 ± 32%, 60 ± 31%, and 64 ± 28%, respectively; P = .42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP-4i alone (2%) compared to DPP-4i plus basal (9%) and basal-bolus (10%); P = .004. Conclusion: Treatment with DPP-4i alone or in combination with basal insulin is effective and results in a lower incidence of hypoglycemia compared to a basal-bolus insulin regimen in general medicine and surgery patients with T2D. Abbreviations: BG = blood glucose; BMI = body mass index; CI = confidence interval; DPP-4i = dipeptidyl peptidase-4 inhibitors; HbA1c = hemoglobin A1c; OR = odds ratio; T2D = type 2 diabetes

scholarly journals Use of Linagliptin for the Management of Medicine Department Inpatients with Type 2 Diabetes in Real-World Clinical Practice (Lina-Real-World Study)

2018 ◽  
Vol 7 (9) ◽  
pp. 271 ◽  
Author(s):  
Luis Pérez-Belmonte ◽  
Juan Gómez-Doblas ◽  
Mercedes Millán-Gómez ◽  
María López-Carmona ◽  
Ricardo Guijarro-Merino ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Practice ◽  
Blood Glucose ◽  
Real World ◽  
Basal Insulin ◽  
Insulin Regimen ◽  
Medicine Department ◽  
Bolus Insulin ◽  
Basal Bolus

The use of noninsulin antihyperglycaemic drugs in the hospital setting has not yet been fully described. This observational study compared the efficacy and safety of the standard basal-bolus insulin regimen versus a dipeptidyl peptidase-4 inhibitor (linagliptin) plus basal insulin in medicine department inpatients in real-world clinical practice. We retrospectively enrolled non-critically ill patients with type 2 diabetes with mild to moderate hyperglycaemia and no injectable treatments at home who were treated with a hospital antihyperglycaemic regimen (basal-bolus insulin, or linagliptin-basal insulin) between January 2016 and December 2017. Propensity score was used to match patients in both treatment groups and a comparative analysis was conducted to test the significance of differences between groups. After matched-pair analysis, 227 patients were included per group. No differences were shown between basal-bolus versus linagliptin-basal regimens for the mean daily blood glucose concentration after admission (standardized difference = 0.011), number of blood glucose readings between 100–140 mg/dL (standardized difference = 0.017) and >200 mg/dL (standardized difference = 0.021), or treatment failures (standardized difference = 0.011). Patients on basal-bolus insulin received higher total insulin doses and a higher daily number of injections (standardized differences = 0.298 and 0.301, respectively). Basal and supplemental rapid-acting insulin doses were similar (standardized differences = 0.003 and 0.012, respectively). There were no differences in hospital stay length (standardized difference = 0.003), hypoglycaemic events (standardized difference = 0.018), or hospital complications (standardized difference = 0.010) between groups. This study shows that in real-world clinical practice, the linagliptin-basal insulin regimen was as effective and safe as the standard basal-bolus regimen in non-critical patients with type 2 diabetes with mild to moderate hyperglycaemia treated at home without injectable therapies.

scholarly journals Predicting the Need for Basal-Bolus Insulin in Hospitalized Patients With Hyperglycemia: Is Sliding Scale Sometimes the Answer?

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A429-A430
Author(s):  
Ivana Jankovic ◽  
Minh Nguyen ◽  
Laurynas Kalesinskas ◽  
Jonathan H Chen
Keyword(s):  
Machine Learning ◽  
Basal Insulin ◽  
Hospitalized Patients ◽  
Receiver Operating Curve ◽  
Insulin Regimen ◽  
Electronic Health Record Data ◽  
Sliding Scale ◽  
Bolus Insulin ◽  
Insulin Use ◽  
Basal Bolus

Abstract Uncontrolled blood glucose (BG) is associated with increased risk of infection, complications, and mortality in hospitalized patients. American Diabetes Association guidelines currently recommend basal insulin for all hospitalized, non-critically ill patients requiring insulin and state that “use of only a sliding scale insulin regimen in the inpatient hospital setting is strongly discouraged”. In practice, however, sliding scale only is used not infrequently. Here, we challenge the recommendation for universal basal insulin use and leverage machine learning to predict which inpatients would indeed benefit from basal insulin at time of admission. Querying inpatient electronic health record data for hospitalizations between 2008–2020, we identified a cohort of 16,868 unique patients who achieved a day of “good control”, defined as ≥ 3 BGs that were within 100–180 mg/dL without any values outside that range. Inclusion criteria were adult inpatients receiving subcutaneous insulin with BG of 100-180mg/dL on one calendar day. If patients had more than one “good day”, the first day of their most recent hospitalization was chosen. We excluded patients ordered for insulin pumps, insulin infusion, any insulin type that is rarely used (ordered &lt; 25 times), TPN or PPN, or tube feeds. We also excluded patients with missing weights. We aimed to predict which patients would require &gt; 6 units of insulin. We chose this threshold clinically, as patients with a total daily dose (TDD) of insulin &lt; 6 units could reasonably be managed on sliding scale insulin alone. Using the threshold of 6 units, we used an ensemble machine learning method, called SuperLearner, to model a binary classification for high vs. low insulin users. Features included in the algorithm were collected prior to prediction time, including weight, height, age, sex, race, insurance status, A1c categories (normal, high, panic high, and missing), creatinine, diet, steroid use in prior 48 hours, admission BG, summary statistics of BG, numerous counts of relevant lab values in quantiles, history of basal insulin use, and counts of major diagnosis code groups. Prior insulin doses were not considered to better simulate admission insulin dosing. Compared to using only weight in the model, with an area under the receiver operating curve (AUROC) of 0.59, our machine learning algorithm showed excellent predictive ability, with an AUROC of 0.85 (95% CI: 0.84 - 0.87) and area under the precision recall curve (AUPRC) of .65 (95% CI: 0.64 - 0.68) vs 0.29 with the weight-only model. Although it will need to be validated prospectively, our algorithm could be used to emphasize basal-bolus insulin on admission in patients predicted to require more insulin, whereas those predicted to require less could be started on sliding scale insulin or considered for oral anti-hyperglycemics.

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