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Insulin Dosing

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141. Insulin Dosing

Insulin Dosing Insulin Dosing Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Insulin Dosing Insulin Dosing Aka: Insulin Dosing From (...) for consistent pattern in s for >3 days Compare for same time each day For each time of day: Calculate range Calculate median Consider eating and activity patterns during day Ignore spurious values Adjust only one dose at a time Correct first Correct highest s next Maintain a 50:50 mix of Basal to VI. Evaluation: Adjustment of Insulin Adjustment factors (for lows and highs) Adjust in small steps at a time Adjustment steps based on amount dose <10 units: Adjust by 1 unit dose 10-20 units: Adjust by 2 units

2018 FP Notebook

142. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. Full Text available with Trip Pro

Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. Exposing the oral mucosa to antigen may stimulate immune tolerance. It is unknown whether treatment with oral insulin can induce a tolerogenic immune response in children genetically susceptible to type 1 diabetes.To assess the immune responses and adverse events associated with orally administered insulin in autoantibody-negative, genetically at-risk (...) children.The Pre-POINT study, a double-blind, placebo-controlled, dose-escalation, phase 1/2 clinical pilot study performed between 2009 and 2013 in Germany, Austria, the United States, and the United Kingdom and enrolling 25 islet autoantibody-negative children aged 2 to 7 years with a family history of type 1 diabetes and susceptible human leukocyte antigen class II genotypes. Follow-up was completed in August 2013.Children were randomized to receive oral insulin (n = 15) or placebo (n = 10) once daily

2015 JAMA Controlled trial quality: predicted high

143. Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues

%. The recommended treatment approach is intensive insulin therapy using multi- ple subcutaneous insulin doses or continuous subcutaneous insulin infusion (CSII) using a personal insulin pump. (A) •A key element of therapy for diabetes type 1 is the patient’s ability to modify insulin doses based on carbohydrate meal content, baseline blood glucose level, and planned physical activity. Knowledge of the effect of protein and fat on blood glucose level is also important for optimization of insulin dosage. (E (...) Medicinal Products BG Blood Glucose BHB B-HydroxyButyrate BMI Body Mass Index CI Confidence Interval CFB Capillary Finger-stick Blood CFB Change From Baseline CGM Continuous Glucose Monitoring CHMP Committee for Medicinal Products for Human use CrI Credible Interval CSII Continuous Subcutaneous Insulin Infusion CSR Clinical Study Report CTR Clinical Trials Register CVD Cardiovascular Disease DBP Diastolic Blood Pressure DDG Deutsche Diabetes Gesellschaft DDS2 Diabetes Distress Screening Scale DIC

2019 EUnetHTA

144. Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial. Full Text available with Trip Pro

Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial. This trial assessed the efficacy and safety of the possibility of varying the daily injection time of once-daily, long-acting basal insulin degludec (IDeg) in Japanese patients with type 2 diabetes inadequately controlled with insulin glargine.This was a 26-week, multicenter, open (...) -label, randomized, treat-to-target trial, with a 2 × 2 factorial design comparing IDeg flexible (allowing dosing ±8 h from an agreed dosing time) with IDeg fixed dosing (at the same time each day). It was carried out in 458 adult patients who were inadequately controlled on insulin glargine with or without oral antidiabetic drugs.The majority of doses were taken within 2 h of the agreed dosing time, showing a high level of adherence among Japanese patients. After 26 weeks, IDeg flexible was non

2016 Journal of Diabetes Investigation Controlled trial quality: uncertain

145. Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

: Standard initial dose of insulin glargine Dose 1 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. Drug: INSULIN GLARGINE Pharmaceutical form: solution Route of administration: subcutaneous injection Other Name: HOE901 Drug: metformin Pharmaceutical form: table or capsule Route of administration: oral (...) administration Drug: acarbose Pharmaceutical form: table or capsule Route of administration: oral administration Experimental: Higher initial dose of insulin glargine Dose 2 of insulin glargine will be administered subcutaneously once a day at the same time every day. Previous non-sulfonylurea OADs (eg, metformin, acarbose) are background treatment and will be continued at the same dosage and dosing frequency as before. Drug: INSULIN GLARGINE Pharmaceutical form: solution Route of administration

2016 Clinical Trials

146. Influence of initial insulin dosage on blood glucose dynamics of children and adolescents with newly diagnosed type 1 diabetes mellitus. Full Text available with Trip Pro

Influence of initial insulin dosage on blood glucose dynamics of children and adolescents with newly diagnosed type 1 diabetes mellitus. To investigate the effect of initial insulin dosage on blood glucose (BG) dynamics, β-cell protection, and oxidative stress in type 1 diabetes mellitus.Sixty newly diagnosed type 1 diabetes mellitus patients were randomly assigned to continuous subcutaneous insulin infusions of 0.6 ± 0.2 IU/kg/d (group 1), 1.0 ± 0.2 IU/kg/d (group 2), or 1.4 ± 0.2 IU/kg/d (...) (group 3) for 3 wk. BG was monitored continuously for the first 10 d and the last 2 d of wk 2 and 3. A total of 24-hour urinary 8-iso-PGF2α was assayed on days 8, 9, and 10. The occurrence and duration of the honeymoon period were recorded. Fasting C-peptide and glycosylated hemoglobin (HbA1c) were assayed after 1, 6, and 12 months of insulin treatment.BG decreased to the target range by the end of wk 3 (group 1), wk 2 (group 2), or wk 1 (group 3). The actual insulin dosage over the 3 wk, frequency

2017 Pediatric diabetes Controlled trial quality: uncertain

147. Treatment of Pre-pubertal Patients with Growth Hormone Deficiency: Patterns in Growth Hormone Dosage and Insulin-like Growth Factor-I Z-scores Full Text available with Trip Pro

Treatment of Pre-pubertal Patients with Growth Hormone Deficiency: Patterns in Growth Hormone Dosage and Insulin-like Growth Factor-I Z-scores To describe the range of insulin-like growth factor-I (IGF-I) z-score values (IGF-Iz) and growth hormone (GH) dose adjustments in pre-pubertal patients with GH deficiency (GHD) treated with GH in a single tertiary care center.This is a retrospective review of GH-treated patients of ages ≤9 years with GHD, seen in an endocrinology clinic in 2013-2014 (...) . Patient demographics and pre-treatment anthropometrics, GH treatment duration, IGF-Iz, and GH dosage (mg/kg/week) were extracted. Multipredictor linear regression was used to evaluate the associations between IGF-Iz and GH dosage and subject gender, race, insurance type, age, and clinical characteristics. Logistic regression was used to calculate the odds ratio of direction of GH dose adjustment (decrease/no change versus increase) and IGF-Iz category based on patient clinical characteristics

2017 Journal of clinical research in pediatric endocrinology

148. Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial. Full Text available with Trip Pro

Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial. Neonatal hyperglycaemia is frequently treated with insulin, which may increase the risk of hypoglycaemia. Computer-determined dosage of insulin (CDD) with the STAR-GRYPHON program uses a computer model to predict an effective dose of insulin to treat hyperglycaemia while minimising the risk of hypoglycaemia. However, CDD models can require more frequent blood (...) , at least 4 hours apart) will be randomised to one of three groups: (1) CDD using the STAR-GRYPHON model-based decision support system: insulin dose and frequency of blood glucose testing advised by STAR-GRYPHON, with a maximum testing interval of 4 hours; (2) bedside titration: insulin dose determined by medical staff, maximum blood glucose testing interval of 4 hours; (3) standard care: insulin dose and frequency of blood glucose testing determined by medical staff. The target range for blood glucose

2017 BMJ open Controlled trial quality: predicted high

149. Effect of one time high dose "stoss therapy" of vitamin D on glucose homeostasis in high risk obese adolescents. Full Text available with Trip Pro

Effect of one time high dose "stoss therapy" of vitamin D on glucose homeostasis in high risk obese adolescents. To study the effect of using a one time high dose "stoss therapy" of vitamin D2 (ergocalciferol: VD2) on indices of insulin sensitivity {whole body sensitivity index: WBISI} and secretion {insulinogenic index: IGI} measured during an oral glucose tolerance test (OGTT) in obese adolescents with VDD (25 OHD; serum metabolite of vit D: < 30 ng/dL).In a randomized placebo controlled (...) respectively.Adolescents were obese and insulin resistant (mean ± SD: mean age = 15.1 ± 1.9 years; BMI: 32.7 ± 9.8; homeostatic model of insulin resistance: HOMA-IR: 4.2 ± 2.8). Stoss therapy with VD2 increased 25OHD from baseline (16.7 ± 2.9 to 19.5 ± 4.5; p = 0.0029) when compared to the placebo. WBISI (2.8 ± 1.9) showed a trend towards improvement in Rx group (p = 0.0577) after adjustment for covariates. IGI (3 ± 2.2) showed an improvement in both Rx and placebo groups.Our study demonstrated that using a high dose

2018 Archives of endocrinology and metabolism Controlled trial quality: uncertain

150. Insulin degludec requires lower bolus insulin doses than does insulin glargine in Japanese diabetic patients with insulin-dependent state. Full Text available with Trip Pro

Insulin degludec requires lower bolus insulin doses than does insulin glargine in Japanese diabetic patients with insulin-dependent state. The study presents a comparison of the glucose-lowering effects, glycemic variability, and insulin doses during treatment with insulin degludec or insulin glargine.In this open-label, single-center, 2-way crossover study, 13 Japanese diabetic outpatients in the insulin-dependent state on basal-bolus therapy were assigned to receive either insulin glargine (...) followed by insulin degludec, or insulin degludec followed by insulin glargine. Basal insulin doses were fixed in principle, and patients self-adjusted their bolus insulin doses. Seventy-two-hour continuous glucose monitoring was performed 2 weeks after switching the basal insulin.Mean blood glucose (mg/dL) was not significantly different between insulin degludec and insulin glargine over 48 hours (141.8 ± 35.2 vs 151.8 ± 43.3), at nighttime (125.6 ± 40.0 vs 124.7 ± 50.4), or at daytime (149.3 ± 37.1

2015 Journal of diabetes science and technology Controlled trial quality: uncertain

151. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Full Text available with Trip Pro

Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Initiation and titration of human regular U-500 insulin (U-500R) with a dosing algorithm of either thrice daily (TID) or twice daily (BID) improved glycemic control with fewer injections in patients with type 2 diabetes treated with high-dose, high-volume U-100 insulin. The objective (...) and BID groups (and no differences between TID and BID groups) from baseline to endpoint. VAS-ISP scores improved for both treatment groups (-5.60 TID; -6.47 BID; p < .05 for both) from baseline to endpoint.U500 can be successfully titrated for improved glycemic control using BID and TID regimens with diabetes-specific Patient-Reported Outcomes showing improvements in both arms; however, BID had better scores than TID in overall, treatment burden, daily life, and compliance domains.These secondary

2016 Health and quality of life outcomes Controlled trial quality: uncertain

152. Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed Full Text available with Trip Pro

Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed Improving management of Type 1 diabetes in the UK: the Dose Adjustment for Normal Eating (DAFNE) programme as a research test-bed. A mixed method analysis of the barriers and facilitators to successful diabetes self management, a health economic analysis, a cluster RCT of different models of delivery of an educational intervention and the potential of insulin pumps

2014 NIHR HTA programme

153. CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

will be assessed. Safety and tolerability will be assessed using adverse event (AE) monitoring, measurement of vital signs, recording 12-lead electrocardiogram (ECG), physical examination and clinical laboratory safety tests. Blood samples will be collected at intervals for assay of plasma concentration of CORT125281 and CORT125324. The SAD part of the study is double-blind, randomized and placebo-controlled with respect to CORT125281. Two cohorts, each of 9 subjects, will receive three sequential single doses (...) Measures Go to Primary Outcome Measures : Adverse Events (AEs) [ Time Frame: SAD Cohorts Day 1 to Day 14; MAD Cohorts Day 1 to Day 30 ] Secondary Outcome Measures : AUCtau Pharmacokinetic (PK) parameter [ Time Frame: MAD Cohorts Day 3 to 19 ] Area under the curve over a dose-interval (AUCtau) AUC 0-tz PK parameter [ Time Frame: CORT125281/CORT125324 - SAD Cohorts Day 1 to 4; MAD Cohorts Day 3 to 19; Pioglitizone - MAD Cohort Day 1 to 15 ] Area under the curve from the time of dosing until the last

2017 Clinical Trials

154. Efficacy and Bone Safety of Sotagliflozin Dose 1 and Dose 2 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen. Secondary Objectives: To compare the effects of sotagliflozin dose 1 and dose 2 versus placebo with respect to the percent change in bone mineral density (BMD) at lumbar spine, total hip, and femoral neck, measured by dual-energy X-ray absorptiometry (DXA). To demonstrate the superiority of sotagliflozin dose 1 versus placebo on change in body weight (BW), fasting plasma glucose (FPG), systolic blood pressure (...) Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria : Patients with Type 2 Diabetes (T2D) managed with diet and exercise only or with a stable antidiabetes regimen (in monotherapy or combination therapy that can include oral antidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more than 12 weeks. Patient has given written informed consent to participate in the study in accordance with local regulations. Exclusion criteria: Age <55 years. Women who

2017 Clinical Trials

155. Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

hours after dosing ] Area under the curve of NNC 0113-0217 [ Time Frame: From 0-168 hours after dosing ] Morning fasting plasma glucose [ Time Frame: At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19) ] Morning fasting insulin [ Time Frame: At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19) ] Morning fasting glucagon [ Time Frame: At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19) ] Eligibility Criteria Go to Information (...) Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x

2017 Clinical Trials

156. A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

dose of 1.0 U/kg Drug: BioChaperone® Combo 75/25 at 1.0 U/kg Injection of BioChaperone® Combo 75/25 at 1.0 U/kg Active Comparator: Humalog® Mix25 at 0.8 U/kg Single subcutaneous dose of 0.8 U/kg Drug: Humalog® Mix25 at 0.8 U/kg Injection of Humalog® Mix25 at 0.8 U/kg Outcome Measures Go to Primary Outcome Measures : AUC last_total [ Time Frame: From 0 to 30 hours ] Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ (...) years (both inclusive) Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months HbA1c level between 6.5% and 9.0 % (both inclusive) Body mass index between 20.0 and 40.0 kg/m2 (both inclusive) Body weight <= 125.0 kg at the screening visit Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day Exclusion Criteria: Type 1 diabetes mellitus Known or suspected hypersensitivity to IMP(s) or related products Previous participation in this trial. Participation is defined as randomised

2017 Clinical Trials

157. Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque

Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque - 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. Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (Rosuzet-IVUS) 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 for details. ClinicalTrials.gov Identifier

2017 Clinical Trials

158. Dose-response effects of sex hormone concentrations on body composition and adipokines in medically castrated healthy men administered graded doses of testosterone gel. Full Text available with Trip Pro

and insulin concentrations were measured at baseline and week 10.Forty-eight men completed the study. A significant treatment effect was observed for change in lean mass (ANOVAP=.01) but not fat mass (P=.14). Lean mass increased in the 15 g T group relative to all lower dose groups, except the 10 g T group. When all subjects were analysed together, changes in lean mass correlated directly and changes in fat mass correlated inversely with serum T, E2 and DHT. No changes were noted in serum glucose, insulin (...) Dose-response effects of sex hormone concentrations on body composition and adipokines in medically castrated healthy men administered graded doses of testosterone gel. Serum sex steroid concentrations may alter body composition and glucose homoeostasis in men in a dose-response manner. We evaluated these end-points in healthy men rendered medically castrate through use of a gonadotrophin-releasing hormone antagonist (acyline) with incremental doses of exogenous testosterone (T) gel.Subjects (n

2017 Clinical endocrinology Controlled trial quality: uncertain

159. Insulin in a Pill: Barriers to Development of Oral Insulin

if the medication can’t be created and brought to market, though researchers have been trying to do so for nearly one hundred years. The first attempt at delivering insulin orally came in 1922, one year after the protein’s discovery. Researchers soon recognized that even the highest doses of oral .[4] Why is it so hard to make an oral insulin pill? The main reason is that insulin has a low oral bioavailability; it is very difficult for an intact insulin peptide to get from your mouth to your circulation without (...) Insulin in a Pill: Barriers to Development of Oral Insulin Insulin in a Pill: Barriers to Development of Oral Insulin – Clinical Correlations Search Insulin in a Pill: Barriers to Development of Oral Insulin May 8, 2018 4 min read By Nicolas Gillingham Peer Reviewed Over 30 million Americans—9.4% of the population—live with diabetes, .[1] Insulin can be self-administered by subcutaneous injection, either classically via a syringe, an insulin pen, or using an insulin pump. However, patients

2018 Clinical Correlations

160. Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes Full Text available with Trip Pro

Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes Patients with type 1 diabetes who do aerobic exercise often experience a drop in blood glucose concentration that can result in hypoglycemia. Current approaches to prevent exercise-induced hypoglycemia include reduction in insulin dose or ingestion of carbohydrates, but these strategies may still result in hypoglycemia or hyperglycemia. We sought to determine whether mini-dose glucagon (MDG) given (...) subcutaneously before exercise could prevent subsequent glucose lowering and to compare the glycemic response to current approaches for mitigating exercise-associated hypoglycemia.We conducted a four-session, randomized crossover trial involving 15 adults with type 1 diabetes treated with continuous subcutaneous insulin infusion who exercised fasting in the morning at ∼55% VO2max for 45 min under conditions of no intervention (control), 50% basal insulin reduction, 40-g oral glucose tablets, or 150-μg

2018 EvidenceUpdates

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