Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)

Introduction: Continuous glucose monitoring (CGM) is a better tool to detect hyper and hypoglycemia than capillary point of care in insulin-treated patients during hospitalization. We evaluated the incidence of hypoglycemia in patients with type 2 diabetes (T2D) treated with basal bolus insulin regimen using CGM and factors associated with hypoglycemia. Methods: Post hoc analysis of a prospective cohort study. Hypoglycemia was documented in terms of incidence rate and percentage of time <54 mg/dL (3.0 mmol/L) and <70 mg/dL (3.9 mmol/L). Factors evaluated included glycemic variability analyzed during the first 6 days of basal bolus therapy. Results: A total of 34 hospitalized patients with T2D in general ward were included, with admission A1c of 9.26 ± 2.62% (76.8 ± 13 mmol/mol) and mean blood glucose of 254 ± 153 mg/dL. There were two events of hypoglycemia below 54 mg/dL (3.0 mmol/L) and 11 events below 70 mg/dL (3.9 mmol/L) with an incidence of hypoglycemic events of 0.059 and 0.323 per patient, respectively. From second to fifth day of treatment the percentage of time in range (140-180 mg/dL, 7.8-10.0 mmol/L) increased from 72.1% to 89.4%. Factors related to hypoglycemic events <70 mg/dL (3.9 mmol/L) were admission mean glucose (IRR 0.86, 95% CI 0.79, 0.95, P < .01), glycemic variability measured as CV (IRR 3.12, 95% CI 1.33, 7.61, P < .01) and SD, and duration of stay. Conclusions: Basal bolus insulin regimen is effective and the overall incidence of hypoglycemia detected by CGM is low in hospitalized patients with T2D. Increased glycemic variability as well as the decrease in mean glucose were associated with events <70 mg/dL (3.9 mmol/L).

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Efficacy And Safety of Empagliflozin Continuation in Patients With Type 2 Diabetes Hospitalised For Acute Decompensated Heart Failure

10.21203/rs.3.rs-408104/v1 ◽

2021 ◽

Author(s):

Luis M Pérez-Belmonte ◽

Michele Ricci ◽

Jaime Sanz-Cánovas ◽

Mercedes Millán-Gómez ◽

Julio Osuna-Sánchez ◽

...

Keyword(s):

Heart Failure ◽

Type 2 Diabetes ◽

Urine Output ◽

Acute Decompensated Heart Failure ◽

Decompensated Heart Failure ◽

Insulin Regimen ◽

Propensity Matching ◽

Bolus Insulin ◽

Basal Bolus

Abstract Background: Sodium−glucose cotransporter 2 inhibitors have been shown to reduce hospitalisations for acute decompensated heart failure in patients with and without type 2 diabetes. However, there is little evidence on their use in hospitalised patients. This work aims to analyse the glycaemic and clinical efficacy and safety of empagliflozin continuation in patients with type 2 diabetes hospitalised for acute decompensated heart failure.Methods: This real-world study included non-critically ill patients with diabetes hospitalised for acute decompensated heart failure and treated with empagliflozin for at least three months prior to the hospitalisation between 2017 and 2020. According to our in-hospital antihyperglycaemic protocol, patients could be treated with two possible regimens: a basal-bolus insulin regimen and an empagliflozin-basal insulin regimen. Our primary endpoints were difference in glycaemic control, as measured via mean daily blood glucose level, and differences in the visual analogue scale dyspnoea score, NT-proBNP levels, diuretic response, and cumulative urine output. Safety endpoints were also analysed. A propensity matching analysis was used to match a patient on one regimen with a patient on the other regimen. The probability of starting the regimes was estimated with a logistic regression model including variables that could have affected treatment assignment or outcomes as independent variablesResults: After a propensity matching analysis, 91 patients were included in each group. There were no differences in mean blood glucose levels (152.1 ± 17.8 vs 155.2 ± 19.7 mg/dl, p=0.289). At discharge, NT-proBNP levels were lower and cumulative urine output greater in the empagliflozin group versus the basal-bolus insulin group (1,652 ± 501 vs 2,101 ± 522 pg/mL, p=0.032 and 16,100 ± 1,510 vs 13,900 ± 1,220 ml, p=0.037, respectively). Patients who continued empagliflozin had a lower total number of hypoglycaemic episodes (36 vs 64, p<0.001). No differences were observed in adverse events, length of hospital stay, or in-hospital deaths.Conclusions: For patients with acute heart failure, an in-hospital antihyperglycaemic regimen that includes continuation of empagliflozin achieved effective glycaemic control, lower NT-proBNP, and greater urine output. It was also safer, as it reduced hypoglycaemic episodes without increasing other safety endpoints.

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Comparison of the FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-Care Capillary Glucose Testing (POC) in Hospitalized Patients With Type 2 Diabetes (T2D) Treated With Basal-Bolus Insulin Regimen

Diabetes Care ◽

10.2337/dc19-2073 ◽

2020 ◽

pp. dc192073 ◽

Cited By ~ 4

Author(s):

Rodolfo J. Galindo ◽

Alexandra L. Migdal ◽

Georgia M. Davis ◽

Maria A. Urrutia ◽

Bonnie Albury ◽

...

Keyword(s):

Type 2 Diabetes ◽

Point Of Care ◽

Glucose Monitoring ◽

Insulin Regimen ◽

Glucose Testing ◽

Freestyle Libre ◽

Capillary Glucose ◽

Bolus Insulin ◽

Basal Bolus

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Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro with Lispro in a Basal-Bolus Regimen in Patients with Type 2 Diabetes: PRONTO-T2D

10.2337/figshare.12149319.v1 ◽

2020 ◽

Cited By ~ 3

Author(s):

Thomas Blevins ◽

Qianyi Zhang ◽

Juan P Frias ◽

Hideaki Jinnouchi ◽

Annette M Chang

Keyword(s):

Type 2 Diabetes ◽

Postprandial Glucose ◽

Treat To Target ◽

Insulin Regimen ◽

Double Blind ◽

Significant Treatment ◽

Double Blind Clinical Trial ◽

Bolus Insulin ◽

Basal Bolus

OBJECTIVE To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS This was a Phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi (n=336) or lispro (n=337) injected 0 to 2 minutes prior to meals. Patients could continue metformin and/or sodium glucose co-transporter-2 inhibitor. The primary end point was change from baseline HbA1c to 26 weeks (noninferiority margin 0.4%), with multiplicity adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test. RESULTS HbA1c improved for both URLi and lispro and noninferiority was confirmed: estimated treatment difference (ETD) +0.06% (95% CI -0.05; 0.16). Mean change in HbA1C was -0.38% for URLi and -0.43% for lispro, with an end of treatment HbA1c of 6.92% and 6.86% respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-hour ETD, -0.66 mmol/L (95% CI -1.01, -0.30); 2-hour ETD, -0.96 mmol/L (-1.41, -0.52). Significantly lower PPG excursions were evident from 0.5 to 4 hours postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments. CONCLUSIONS URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA1c and superior to lispro for PPG control in patients with type 2 diabetes.

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Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro with Lispro in a Basal-Bolus Regimen in Patients with Type 2 Diabetes: PRONTO-T2D

10.2337/figshare.12149319 ◽

2020 ◽

Cited By ~ 2

Author(s):

Thomas Blevins ◽

Qianyi Zhang ◽

Juan P Frias ◽

Hideaki Jinnouchi ◽

Annette M Chang

Keyword(s):

Type 2 Diabetes ◽

Postprandial Glucose ◽

Treat To Target ◽

Insulin Regimen ◽

Double Blind ◽

Significant Treatment ◽

Double Blind Clinical Trial ◽

Bolus Insulin ◽

Basal Bolus

OBJECTIVE To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS This was a Phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi (n=336) or lispro (n=337) injected 0 to 2 minutes prior to meals. Patients could continue metformin and/or sodium glucose co-transporter-2 inhibitor. The primary end point was change from baseline HbA1c to 26 weeks (noninferiority margin 0.4%), with multiplicity adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test. RESULTS HbA1c improved for both URLi and lispro and noninferiority was confirmed: estimated treatment difference (ETD) +0.06% (95% CI -0.05; 0.16). Mean change in HbA1C was -0.38% for URLi and -0.43% for lispro, with an end of treatment HbA1c of 6.92% and 6.86% respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-hour ETD, -0.66 mmol/L (95% CI -1.01, -0.30); 2-hour ETD, -0.96 mmol/L (-1.41, -0.52). Significantly lower PPG excursions were evident from 0.5 to 4 hours postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments. CONCLUSIONS URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA1c and superior to lispro for PPG control in patients with type 2 diabetes.

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