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Insulin Dosing in Type 1 Diabetes

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1. Dapagliflozin with insulin for treating type 1 diabetes

for treating type 1 diabetes (TA597) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 241 1 Recommendations Recommendations 1.1 Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m 2 , when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if: they are on insulin doses of more than 0.5 (...) with type 1 diabetes with a 'low insulin need' . It should not be started in people with a glomerular filtration rate (GFR) of less than 60 ml/min and should be stopped at a GFR persistently below 45 ml/min. During treatment with dapagliflozin, insulin therapy should be continuously optimised to prevent ketosis and diabetic ketoacidosis, and the insulin dose should only be reduced to avoid hypoglycaemia. This treatment should only be 'started and supervised by specialist doctors' . Patients should

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

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

by the prescribing healthcare professional. Dose adjustments No dose adjustment is recommended. No dose adjustment is recommended. No dose adjustment is recommended. Abbreviations: SPC=summary of product characteristics PTJA04 - Sotagliflozin is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) = 27 kg/m 2 , who have failed to achieve adequate glycaemic control despite optimal insulin therapy June 2019 EUnetHTA Joint (...) %. 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

2019 EUnetHTA

3. Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes?

% in the liraglutide group compared with 0.3% in the placebo group. 44 There was a 20% reduction in insulin dose in the liraglutide group but no change in the placebo group. 44 It is unknown whether these differences are statistically significant, as statistical testing was not reported. 44 Results from another phase II/III trial of liraglutide in T1D patients, the Lira Pump Trial (The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial), should soon (...) error; SGLT-2 = sodium glucose cotransporter-2; T1D = type 1 diabetes. a P value < 0.05 when compared with placebo. Overall, use of SGLT-2 inhibitors as adjunctive therapy to insulin appears to reduce A1C, 13,20,25 total daily insulin dose, 13,24,25 and weight compared with placebo. 13,20,24,25 Where statistical comparison was available, SGLT-2 inhibitors reduced A1C by approximately 0.3% to 0.7%. 13,20,25 Available data indicate a small numerical decrease in FPG when SGLT-2 inhibitors were added

2018 CADTH - Issues in Emerging Health Technologies

4. Higher rates of large-for-gestational-age newborns mediated by excess maternal weight gain in pregnancies with Type 1 diabetes and use of continuous subcutaneous insulin infusion vs multiple dose insulin injection. (PubMed)

Higher rates of large-for-gestational-age newborns mediated by excess maternal weight gain in pregnancies with Type 1 diabetes and use of continuous subcutaneous insulin infusion vs multiple dose insulin injection. To compare glycaemic control, maternal and neonatal outcomes in pregnancies with Type 1 diabetes, managed either by continuous subcutaneous insulin infusion, multiple daily insulin injection or switch from multiple daily insulin injection (MDI) to continuous subcutaneous insulin (...) infusion (CSII) in early pregnancy.Data from 339 singleton pregnancies were retrospectively reviewed. HbA1c values were measured preconception and in each trimester. In a secondary analysis, use of CSII pre-pregnancy was compared with initiation of CSII during pregnancy.MDI was used in 140 pregnancies (41.3%) and CSII was used in 199 (58.7%), including 34 pregnancies (10.0%) during which the women switched to CSII. In pregnancies during which CSII was used duration of diabetes [median (interquartile

2019 Diabetic Medicine

5. 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

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 EvidenceUpdates

6. A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes

A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes To compare systematically the impact of two novel insulin-dosing algorithms (the Pankowska Equation and the Food Insulin Index) with carbohydrate counting on postprandial glucose excursions following a high fat and a high protein meal.A randomized, crossover trial at two Paediatric Diabetes centres was conducted. On each day, participants consumed a high protein or high fat meal (...) at the expense of an increase in hypoglycaemia. There were no significant differences when carbohydrate counting was compared to the Food Insulin Index. Further research is required to optimize prandial insulin dosing.© 2018 Diabetes UK.

2018 EvidenceUpdates

7. Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial. (PubMed)

Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial. Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine (...) the appropriate next insulin dose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone.In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21-70 years, diagnosed with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58

2019 Lancet

8. Addition of canagliflozin to insulin improves glycaemic control and reduces insulin dose in patients with type 2 diabetes mellitus: A randomized controlled trial

Addition of canagliflozin to insulin improves glycaemic control and reduces insulin dose in patients with type 2 diabetes mellitus: A randomized controlled trial The aim of this study was to evaluate the efficacy of canagliflozin in reducing the required insulin dose and the risk of hypoglycaemia in type 2 diabetes (T2D). This study was conducted in patients with T2D treated with insulin. They were randomly assigned to the control (n = 17) and canagliflozin (n = 17, plus 100 mg/day (...) canagliflozin) groups. In both groups, a defined insulin dose adjustment protocol was applied to achieve the same level of glycaemic control. The change from baseline in daily insulin dose was significantly smaller in the canagliflozin group (3.9 units/day) than in the control group (13.4 units/day; P = 0.040). Low blood glucose index and predicted % of blood glucose (BG) <70 mg/dL, which are hypoglycaemia-related variables, worsened significantly in the control group but both remained unchanged

2019 EvidenceUpdates

9. Preserved glucose response to low-dose glucagon after exercise in insulin-pump-treated individuals with type 1 diabetes: a randomised crossover study. (PubMed)

Preserved glucose response to low-dose glucagon after exercise in insulin-pump-treated individuals with type 1 diabetes: a randomised crossover study. This study aimed to compare the increase in plasma glucose after a subcutaneous injection of 200 μg glucagon given after 45 min of cycling with resting (study 1) and to investigate the effects of glucagon when injected before compared with after 45 min of cycling (study 2). We hypothesised that: (1) the glucose response to glucagon would (...) be similar after cycling and resting; and (2) giving glucagon before the activity would prevent the exercise-induced fall in blood glucose during exercise and for 2 h afterwards.Fourteen insulin-pump-treated individuals with type 1 diabetes completed three visits in a randomised, placebo-controlled, participant-blinded crossover study. They were allocated by sealed envelopes. Baseline values were (mean and range): HbA1c 54 mmol/mol (43-65 mmol/mol) or 7.1% (6.1-8.1%); age 45 years (23-66 years); BMI 26

2019 Diabetologia

10. Association of Insulin Dose, Cardiometabolic Risk Factors, and Cardiovascular Disease in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study. (PubMed)

Association of Insulin Dose, Cardiometabolic Risk Factors, and Cardiovascular Disease in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study demonstrated the beneficial effects of intensive therapy on atherosclerosis and clinical cardiovascular disease (CVD) outcomes. The current analyses evaluated the relationship between longitudinal changes in insulin dose (...) risk of any CVD (95% CI 3, 9). However, the association with insulin dose was no longer significant after adjustment for other CVD risk factors.During DCCT/EDIC, higher insulin doses were associated with adverse trends in several cardiometabolic risk factors, even after multivariable adjustment, but not with incident CVD outcomes.© 2019 by the American Diabetes Association.

2019 Diabetes Care

11. Effect of single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase 1 randomized trial. (PubMed)

Effect of single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase 1 randomized trial. This report describes novel clinical data assessing pharmacodynamics of insulin glargine/lixisenatide (iGlarLixi) compared with placebo and insulin glargine alone, to determine pharmacokinetics of lixisenatide, and to assess safety of iGlarLixi in Japanese patients with type 2 diabetes (...) mellitus (T2DM). In a single-center, open-label, randomized, placebo-controlled crossover study, patients received subcutaneous iGlarLixi 5U/5μg and 10U/10μg, placebo, and 5U insulin glargine. The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC0-2 ). Twenty patients completed all study periods. iGlarLixi 5U/5μg and 10U/10μg reduced mean PPG dose-dependently compared with placebo and insulin glargine 5U. Both combinations significantly reduced PPG-AUC0-2 dose-dependently

2019 obesity & metabolism

12. Insulin Glargine Dose and Weight Changes in Underweight, Normal Weight, and Overweight Children Newly Diagnosed with Type 1 Diabetes Mellitus. (PubMed)

Insulin Glargine Dose and Weight Changes in Underweight, Normal Weight, and Overweight Children Newly Diagnosed with Type 1 Diabetes Mellitus. Newly diagnosed pediatric patients with type 1 diabetes mellitus (T1D) can be underweight, overweight, or normal weight at presentation. Study objectives were to determine if, across weight categories, admission body weight (ABW)-based initial insulin glargine dosing resulted in similar fasting blood glucose responses on day of discharge, how initial ABW (...) -based doses differed from doses at outpatient follow-up, and whether an ideal body weight (IBW) would provide a better estimate of body weight after discharge.Retrospective chart review.Urban tertiary academic medical center.Eighty-one pediatric patients newly diagnosed with T1D who started therapy with subcutaneous insulin glargine between October 2014 and October 2016; patients were categorized by weight using body mass index (BMI) percentiles (underweight, normal weight, or overweight/obese).Data

2019 Pharmacotherapy

13. A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes. (PubMed)

A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes. To compare systematically the impact of two novel insulin-dosing algorithms (the Pankowska Equation and the Food Insulin Index) with carbohydrate counting on postprandial glucose excursions following a high fat and a high protein meal.A randomized, crossover trial at two Paediatric Diabetes centres was conducted. On each day, participants consumed a high protein or high fat (...) hyperglycaemia at the expense of an increase in hypoglycaemia. There were no significant differences when carbohydrate counting was compared to the Food Insulin Index. Further research is required to optimize prandial insulin dosing.© 2018 Diabetes UK.

2019 Diabetic medicine : a journal of the British Diabetic Association

14. Proportion of Basal to Total Insulin Dose Is Associated with Metabolic Control, Body Mass Index, and Treatment Modality in Children with Type 1 Diabetes-A Cross-Sectional Study with Data from the International SWEET Registry. (PubMed)

Proportion of Basal to Total Insulin Dose Is Associated with Metabolic Control, Body Mass Index, and Treatment Modality in Children with Type 1 Diabetes-A Cross-Sectional Study with Data from the International SWEET Registry. To investigate in a large population the proportion of daily basal insulin dose (BD) to daily total insulin dose (TD) (BD/TD) and its association with glycated hemoglobin A1c (HbA1c), body mass index (BMI)- SDS, and treatment modality in children with type 1 diabetes.Cross (...) -sectional study in subjects with type 1 diabetes, age ≤18 years, and ≥2 years of diabetes duration, registered in the international multicenter Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference registry in March 2018. Variables included region, sex, age, diabetes duration, treatment modality (multiple daily injections [MDI] or continuous subcutaneous insulin infusion [CSII]), self-monitoring blood glucose, HbA1c, BD/TD, and BMI-SDS. BMI was converted to BMI-SDS

2019 Journal of Pediatrics

15. Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus. (PubMed)

Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus. Glucose variability (GV) remains a key limiting factor in the success of diabetes management. While new technologies, for example, accurate continuous glucose monitoring (CGM) and connected insulin delivery devices, are now available, current treatment standards fail to leverage the wealth of information generated. Expert (...) systems, from automated insulin delivery to advisory systems, are a key missing element to richer, more personalized, glucose management in diabetes.Twenty four subjects with type 1 diabetes mellitus (T1DM), 15 women, 37 ± 11 years of age, hemoglobin A1c 7.2% ± 1%, total daily insulin (TDI) 46.7 ± 22.3 U, using either an insulin pump or multiple daily injections with carbohydrate counting, completed two randomized crossover 48-h visits at the University of Virginia, wearing Dexcom G4 CGM, and using

2018 Diabetes technology & therapeutics

16. Adjusting insulin doses in patients with type 1 diabetes that use insulin pump and continuous glucose monitoring - Variations among countries and physicians. (PubMed)

Adjusting insulin doses in patients with type 1 diabetes that use insulin pump and continuous glucose monitoring - Variations among countries and physicians. To evaluate physicians' adjustments of insulin pump settings based on continuous glucose monitoring (CGM) for patients with type 1 diabetes and to compare these to automated insulin dose adjustments.A total of 26 physicians from 16 centres in Europe, Israel and South America participated in the study. All were asked to adjust insulin (...) dosing based on insulin pump, CGM and glucometer downloads of 15 patients (mean age 16.2 ± 4.3 years, six female, mean glycated haemoglobin 8.3 ± 0.9% [66.8 ± 7.3 mmol/mol]) gathered over a 3-week period. Recommendations were compared for the relative changes in the basal, carbohydrate to insulin ratio (CR) and correction factor (CF) plans among physicians and among centres and also between the physicians and an automated algorithm, the Advisor Pro (DreaMed Diabetes Ltd, Petah Tikva, Israel). Study

2018 obesity & metabolism

17. Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes

treatment might actually have been a reflection of the training given to them. Currently just 10% of adults with type 1 diabetes access these training courses. These results support NICE guidelines around the restricted use of insulin pumps and suggest that training improves self-management of the condition. Efforts should therefore be made to encourage training uptake. Share your views on the research. Why was this study needed? People with type 1 diabetes require lifelong treatment with insulin. Doses (...) trial included 317 adults with type 1 diabetes. All participants were first placed on a one week training course ( ) that taught them how to adjust their insulin dose based on estimated carbohydrate intake. They were then randomly allocated to insulin pump or multiple daily injections for two years if their HbA1c values were 7.5% (59mmol/mol) or higher after the education. Blood glucose HbA1c (glycated haemoglobin) is a measure of blood glucose control over several months and was assessed “blind

2019 NIHR Dissemination Centre

18. A Hybrid Closed-Loop Insulin Delivery System for the Treatment of Type 1 Diabetes

in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home (NCT02748018) is planned as a randomized, parallel group study, with recruitment of 1,500 people with type 1 diabetes. The trial will test three MiniMed 670G settings against control groups, using multiple-dose injections, insulin pump technology alone, and sensor-augmented pump technology. 21 Table 1. Characteristics and Findings of Included Studies First Author (Year), Site, Country, Funder Study Design (...) Efficacy: % of time in closed-loop mode: median 87.2% A1C levels: dropped from a mean of 7.4% to 6.9% Daily insulin dose: increased from 47.5 U to 50.9 U % of glucose in target range: increased from 66.7% to 72.2% A1C = glycated hemoglobin; AE = adverse event; CA = California; DKA = diabetic ketoacidosis; DM = diabetes mellitus; MN = Minnesota; NR = not reported; RCT = randomized controlled trial; SAE = serious adverse event; SD = standard deviation; T1DM = type 1 diabetes mellitus; U = unit; vs

2017 CADTH - Issues in Emerging Health Technologies

19. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial

Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy.Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (...) . Treatment-emergent adverse events were observed in 64.5% of alirocumab- vs 64.1% of placebo-treated individuals (overall population).Alirocumab produced significant LDL cholesterol reductions in participants with insulin-treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778).© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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2017 EvidenceUpdates

20. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. (PubMed)

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death.To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes.Double-blind, randomized, crossover noninferiority (...) degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%).Among patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes.clinicaltrials.gov Identifier

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2017 JAMA

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