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Insulin Dosing

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101. Short-term fully closed-loop insulin delivery using faster insulin aspart compared with standard insulin aspart in type 2 diabetes. (PubMed)

insulin dose was higher with faster insulin aspart (mean difference [95% CI] 3.7 U [0.7; 6.8], P = 0.021). No episodes of severe hypoglycaemia or other serious adverse events occurred. In conclusion, short-term fully closed-loop in type 2 diabetes may require higher dose of faster insulin aspart compared with standard insulin aspart to achieve comparable glucose control.© 2019 John Wiley & Sons Ltd. (...) Short-term fully closed-loop insulin delivery using faster insulin aspart compared with standard insulin aspart in type 2 diabetes. We evaluated the efficacy and safety of short-term fully closed-loop insulin delivery using faster versus standard insulin aspart in type 2 diabetes. Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of closed-loop insulin delivery with either faster or standard insulin aspart in a double-blind randomized crossover design. Basal-bolus regimen

2019 obesity & metabolism Controlled trial quality: predicted high

102. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. (PubMed)

insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA1c control compared with IAsp.© 2019 by the American Diabetes Association. (...) Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years

2019 Diabetes Care Controlled trial quality: predicted high

103. Weight loss in patients with type 2 diabetes (T2D) mellitus receiving once-weekly dulaglutide plus insulin lispro or insulin glargine plus insulin lispro: An AWARD-4 post-hoc analysis across baseline body mass index subgroups. (PubMed)

Weight loss in patients with type 2 diabetes (T2D) mellitus receiving once-weekly dulaglutide plus insulin lispro or insulin glargine plus insulin lispro: An AWARD-4 post-hoc analysis across baseline body mass index subgroups. Insulin-treated patients with type 2 diabetes (T2D) and obesity are challenged in achieving body weight stability or reduction, in addition to glycaemic control. Post-hoc analyses of body weight and insulin dose data from the AWARD-4 trial involved comparison of treatment (...) with once-weekly dulaglutide 1.5 mg (N = 295) or 0.75 mg (N = 293) and treatment with daily insulin glargine (N = 296), each with prandial insulin lispro (± metformin).Changes in weight and in the proportion of patients without weight gain or with weight loss of at least 3%, 5% or 10% or composites of HbA1c less than 7% without weight gain and weight loss of at least 3% after 52 weeks were compared between the dulaglutide (either dose) groups and the insulin glargine group, overall and by baseline BMI

2019 obesity & metabolism Controlled trial quality: uncertain

104. The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people (PubMed)

The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people The requirement to inject current basal insulin analogs at a fixed time each day may complicate adherence and compromise glycemic control. This trial evaluated the efficacy and safety of varying the daily injection time of insulin degludec (...) (IDeg), an ultra-long-acting basal insulin.This 26-week, open-label, treat-to-target trial enrolled adults (≥18 years) with type 2 diabetes who were either insulin naïve and receiving oral antidiabetic drugs (OADs) (HbA(1c) = 7-11%) or previously on basal insulin ± OAD(s) (HbA(1c) = 7-10%). Participants were randomized to 1) once-daily (OD) IDeg in a prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n = 229); 2) once-daily IDeg at the main evening meal (IDeg

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2013 EvidenceUpdates Controlled trial quality: uncertain

105. Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I

Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved (...) studies (100). Please remove one or more studies before adding more. Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03053089 Recruitment Status : Completed First Posted : February 14, 2017

2017 Clinical Trials

106. Dapagliflozin in Patients with Type 1 Diabetes: A post-hoc analysis of the effect of insulin dose adjustments on 24-hour continuously monitored mean glucose and fasting beta-hydroxybutyrate levels from a Phase IIa pilot study. (PubMed)

Dapagliflozin in Patients with Type 1 Diabetes: A post-hoc analysis of the effect of insulin dose adjustments on 24-hour continuously monitored mean glucose and fasting beta-hydroxybutyrate levels from a Phase IIa pilot study. To investigate the effects of total daily insulin dose (TDD) reductions on 24-hour continuously monitored mean glucose and fasting β-hydroxybutyrate (a marker for diabetic ketosis/ketoacidosis [DKA]) levels, using patient-level data from a 14-day, pilot study (...) of dapagliflozin in type 1 diabetes (T1DM).A post hoc exploratory correlation analysis was performed to determine the relationship between change in TDD and (1) 24-hour mean glucose, assessed by continuous glucose monitoring, and (2) fasting β-hydroxybutyrate, in 70 patients with T1DM receiving insulin and dapagliflozin (1, 2.5, 5 or 10 mg) or placebo. The pharmacodynamic effect of dapagliflozin was estimated as a virtual "insulin dose" using 24-hour urinary glucose excretion values and a recognized insulin

2017 obesity & metabolism

107. Dose-response effects of exercise on insulin among colon cancer survivors. (PubMed)

Dose-response effects of exercise on insulin among colon cancer survivors. Physical activity is associated with a lower risk of disease recurrence among colon cancer survivors. The pathways through which physical activity may alter disease outcomes are unknown, but may include changes in metabolic growth factors, such as insulin. Between January 2015 and August 2015, 39 stage I-III colon cancer survivors were randomized to one of the three groups: usual care control, 150 min/week of aerobic (...) exercise (low-dose) and 300 min/week of aerobic exercise (high-dose) for six months. The pre-specified key metabolic growth factor outcome was fasting insulin. Insulin resistance was quantified using the homeostatic model assessment. Mean age was 56.5 ± 10.0 years, 51% had stage III disease, 72% were treated with chemotherapy and the mean time since finishing treatment was 10.9 ± 6.1 months. Over six months, the low-dose group completed 141.5 ± 9.9 min/week of aerobic exercise, and the high-dose group

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2017 Endocrine-Related Cancer

108. A comparison of insulin doses for the treatment of hyperkalemia in patients with renal insufficiency. (PubMed)

A comparison of insulin doses for the treatment of hyperkalemia in patients with renal insufficiency. To compare the safety and efficacy of 5 units versus 10 units of insulin for the treatment of hyperkalemia in patients with renal insufficiency.Retrospective cohort study.Large academic medical center emergency department.Between March 1, 2008, and February 29, 2016, 675 patients met the inclusion criteria of age 18 years and older, serum potassium greater than 5 mEq/L, renal insufficiency, 5 (...) units or 10 units of intravenous regular insulin administered in the emergency department, and blood glucose documented within 5 hours after insulin administration. Of these patients, 133 (19.7%) received 5 units of insulin and 542 (80.3%) received 10 units of insulin.The primary outcome was incidence of hypoglycemia (blood glucose < 70 mg/dl). Secondary outcomes were incidence of severe hypoglycemia (blood glucose < 40 mg/dl) and change in serum potassium after insulin therapy. Hypoglycemia

2017 Pharmacotherapy

109. Low dose prednisolone and insulin sensitivity differentially affect arterial stiffness and endothelial function: An open interventional and cross-sectional study. (PubMed)

Low dose prednisolone and insulin sensitivity differentially affect arterial stiffness and endothelial function: An open interventional and cross-sectional study. Glucocorticoids could impair vascular function directly, or indirectly by reducing insulin sensitivity. The aim of this study was to determine the direct and indirect effects of acute and chronic low dose prednisolone on arterial stiffness and endothelial function.Twelve subjects with inflammatory arthritis, who had not taken oral (...) during hyperinsulinemic-euglycemic clamp (p = 0.02), but not with suppression of endogenous glucose production (p = 0.15) or glucocorticoid use (p = 0.70). Chronic (2.4 ± 0.2 vs. 1.9 ± 0.1, p = 0.02), but not acute (1.8 ± 0.2 vs. 1.9 ± 0.1, p = 0.24), prednisolone resulted in a higher RHI.Arterial stiffness is not affected by low dose prednisolone per se, but is negatively associated with peripheral insulin sensitivity. Patients with rheumatoid arthritis taking long-term prednisolone had better

2017 Atherosclerosis

110. Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD

Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Effect of Dosing (...) Details Study Description Go to Brief Summary: A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing prior to meal, duration between meals and type of meal . Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: IN-105 (Insulin Tregopil) Other: Placebo comparator Phase 1 Detailed Description: A Phase 1, Randomized, Placebo Controlled, Crossover Trial in Type 2 Diabetes Patients to evaluate the effect of pre-meal dosing time, inter-meal

2017 Clinical Trials

111. Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment

Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment (ICT) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our

2017 Clinical Trials

112. Associations Between Home Insulin Dose Adjustments and Glycemic Outcomes at Hospital Admission (PubMed)

Associations Between Home Insulin Dose Adjustments and Glycemic Outcomes at Hospital Admission To describe patterns of home insulin dose adjustments for non-surgical, non-critically ill patients at admission and to describe associations between these adjustments and inpatient glycemic control.Hospital records of non-critically ill patients treated with basal insulin prior to admission were identified. After exclusion of records in which a confounding factor influencing insulin dosing (...) was present, 258 patient-admissions over a 3-year time period were included. Multivariate logistic regression was used to analyze the association between adjustments to home insulin total daily dose (TDD) and inpatient glycemic control within the first 48h, adjusting for relevant confounders.On hospital days 1 (HD1) and 2 (HD2), the home insulin TDD was reduced by 43.5% and 23.9%, respectively. Reductions in the home TDD ranging from 10% to 50% were not associated with normoglycemia or hyperglycemia

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2017 Diabetes research and clinical practice

113. A Large Difference in Dose Timing of Basal Insulin Introduces Risk of Hypoglycemia and Overweight: A Cross-Sectional Study (PubMed)

A Large Difference in Dose Timing of Basal Insulin Introduces Risk of Hypoglycemia and Overweight: A Cross-Sectional Study Basal insulin should be injected at the same time each day, but people with diabetes sometimes mistime their injections. It is not known whether irregular daily dose timing affects diabetes-related factors. We report here our evaluation of the effects of deviations from a regular dosing schedule on glycemic control and hypoglycemia on patients treated with long-acting (...) insulin (insulin glargine U100). We also consider the effects of ultra-long-acting insulin (insulin degludec) in this context.Nineteen individuals with type 1 diabetes and 58 with type 2 diabetes were enrolled. Demographic data on all participants were retrieved from their medical records. Variation in dose timing was determined as the difference between the time of the earliest mistimed dose and the time of the latest mistimed dose, for each participant, over a 2-week period. All participants

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2017 Diabetes Therapy

114. Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? (PubMed)

Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? With the increasing accuracy of continuous glucose monitors (CGM) have come calls for the Food and Drug Administration (FDA) to label these devices as safe for nonadjunctive dosing of insulin. However, there is evidence that these devices are subject to sporadic, unpredictable, large errors. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25 000 complaints of CGM sensor inaccuracy

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2017 Journal of diabetes science and technology

115. Commentary Regarding Shapiro, “Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?” (PubMed)

Commentary Regarding Shapiro, “Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?” The FDA recently expanded the approved use of Dexcom's G5 Mobile continuous glucose monitoring (CGM) system to allow for diabetes treatment decisions. This decision is expected to reduce the burden of SMBG testing and increase the adoption and persistent use of CGM. The safety of nonadjunctive CGM use was questioned because of sporadic large discrepancies between CGM and SMBG

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2017 Journal of diabetes science and technology

116. A Methodology to Compare Insulin Dosing Recommendations in Real-Life Settings (PubMed)

A Methodology to Compare Insulin Dosing Recommendations in Real-Life Settings We propose a methodology to analyze complex real-life glucose data in insulin pump users.Patients with type 1 diabetes (T1D) on insulin pumps were recruited from an academic endocrinology practice. Glucose data, insulin bolus (IB) amounts, and self-reported alcohol consumption and exercise events were collected for 30 days. Rules were developed to retrospectively compare IB recommendations from the insulin pump bolus (...) postprandial glucose was higher than target, the PDA suggested higher doses in 25%, lower doses in 13%, and equivalent doses in 62%. In 64% of all alcohol events the PDA would have provided appropriate advice. In 75% of exercise events, the PDA appropriately advised an IB, a carbohydrate snack, or neither.This study provides a methodology to systematically analyze real-life data generated by insulin pumps and allowed a preliminary analysis of the performance of the PDA for insulin dosing. Further testing

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2017 Journal of diabetes science and technology

117. The Safety of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Still Not Resolved (PubMed)

The Safety of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Still Not Resolved 28420260 2018 11 13 1932-2968 11 4 2017 07 Journal of diabetes science and technology J Diabetes Sci Technol The Safety of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Still Not Resolved. 856-857 10.1177/1932296817704446 Shapiro Alan R AR 1 Department of Medicine, New York University School of Medicine, New York, NY, USA. eng Letter 2017 04 18 United States J Diabetes

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2017 Journal of diabetes science and technology

118. Higher-Than-Conventional Subcutaneous Regular Insulin Doses Following Diabetic Ketoacidosis in Children and Adolescents (PubMed)

Higher-Than-Conventional Subcutaneous Regular Insulin Doses Following Diabetic Ketoacidosis in Children and Adolescents To evaluate the effect of initial insulin dosage on glycemic control in the first 48 hours of subcutaneous regular insulin therapy after resolution of diabetic ketoacidosis (DKA).Records of patients with DKA hospitalized in the past 3 years [n=76, median age=10.0 (6.0-12.0) years, Male/Female: 44/32] were reviewed. The patients were designated into two groups according (...) to distribution of starting doses of subcutaneous insulin. Group 1 (n=28) received a median dose of 1.45 U/kg/day (1.41-1.5) and group 2 (n=48) a median dose of 0.96 U/kg/day (0.89-1). Clinical and laboratory data were analyzed.Median, minimum, and maximum blood glucose levels of Group 1 in the first 48 hours of treatment were significantly lower than that of Group 2 [213 (171-242) vs. 255 (222-316), p=<0.001; 102 (85-151) vs. 129 (105-199), p=0.004; and 335 (290-365) vs. 375 (341-438), p=0.001, respectively

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2017 Journal of clinical research in pediatric endocrinology

119. Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems (PubMed)

Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial.For each blood glucose measurement, premeal bolus (...) insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results.In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR®NEXT EZ BGMS (EZ), -0.9 to 0.5; Accu-Chek® Aviva BGMS (ACA), -0.5 to 1.8; FreeStyle

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2017 Journal of diabetes science and technology

120. Glargine and degludec: Solution behaviour of higher dose synthetic insulins (PubMed)

Glargine and degludec: Solution behaviour of higher dose synthetic insulins Single, double and triple doses of the synthetic insulins glargine and degludec currently used in patient therapy are characterised using macromolecular hydrodynamic techniques (dynamic light scattering and analytical ultracentrifugation) in an attempt to provide the basis for improved personalised insulin profiling in patients with diabetes. Using dynamic light scattering and sedimentation velocity in the analytical (...) doses of synthetic insulins remaining in the physiological system for extended periods of time, in some case 24-40 hours, double and triple dose insulins may impact adversely on personalised insulin profiling in patients with diabetes.

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2017 Scientific reports

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