Pub Date : 2023-04-01DOI: 10.1016/j.deman.2023.100135
André J. Scheen
Patients with type 2 diabetes mellitus (T2DM) are exposed to a high risk of atherosclerotic cardiovascular disease, heart failure and chronic kidney disease. The incidence of these complications increases markedly with the duration of diabetes and aging. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) showed a remarkable reduction in hospitalization for heart failure and progression of kidney disease in large prospective placebo-controlled trials. Post hoc analyses of these trials demonstrated that cardiorenal protection occurred independently of age. The present comprehensive review analyzes the effects of SGLT2is on cardiovascular and renal outcomes among older patients with T2DM in cohort studies and real-life conditions. SGLT2is were associated with a significant reduction in hospitalization for heart failure (alone or combined with mortality) and in a composite renal outcome, including end-stage renal disease when compared to other oral glucose-lowering drugs, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists in patients aged ≥ 65 years and even ≥ 75 years. Several observational studies worldwide compared cardiorenal outcomes in people aged ≥ 65 years versus < 65 years and showed a similar relative benefit of SGLT2is in older versus younger patients with T2DM. These favourable results were obtained while the safety profile of SGLT2is in older patients was acceptable and almost comparable with that reported in younger patients. In conclusion, observational studies in real-life conditions confirm previous results reported in placebo-controlled trials and a positive benefit/risk balance in elderly patients with T2DM at risk of heart failure and chronic kidney disease.
{"title":"Cardiovascular and renal outcomes with SGLT2 inhibitors: Real-life observational studies in older patients with type 2 diabetes","authors":"André J. Scheen","doi":"10.1016/j.deman.2023.100135","DOIUrl":"https://doi.org/10.1016/j.deman.2023.100135","url":null,"abstract":"<div><p>Patients with type 2 diabetes mellitus (T2DM) are exposed to a high risk of atherosclerotic cardiovascular disease, heart failure and chronic kidney disease. The incidence of these complications increases markedly with the duration of diabetes and aging. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) showed a remarkable reduction in hospitalization for heart failure and progression of kidney disease in large prospective placebo-controlled trials. Post hoc analyses of these trials demonstrated that cardiorenal protection occurred independently of age. The present comprehensive review analyzes the effects of SGLT2is on cardiovascular and renal outcomes among older patients with T2DM in cohort studies and real-life conditions. SGLT2is were associated with a significant reduction in hospitalization for heart failure (alone or combined with mortality) and in a composite renal outcome, including end-stage renal disease when compared to other oral glucose-lowering drugs, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists in patients aged ≥ 65 years and even ≥ 75 years. Several observational studies worldwide compared cardiorenal outcomes in people aged ≥ 65 years versus < 65 years and showed a similar relative benefit of SGLT2is in older versus younger patients with T2DM. These favourable results were obtained while the safety profile of SGLT2is in older patients was acceptable and almost comparable with that reported in younger patients. In conclusion, observational studies in real-life conditions confirm previous results reported in placebo-controlled trials and a positive benefit/risk balance in elderly patients with T2DM at risk of heart failure and chronic kidney disease.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"10 ","pages":"Article 100135"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49759037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1016/j.deman.2023.100137
Sonsoles Fuentes , Rok Hrzic , Romana Haneef , Sofiane Kab , Emmanuel Cosson , Sandrine Fosse-Edorh
Introduction
Big data sources represent an opportunity for diabetes research. One example is the French national health data system (SNDS), gathering information on medical claims of out-of-hospital health care and hospitalizations for the entire French population (66 million). Currently, a validated algorithm based on antidiabetic drug reimbursement is able to identify people with pharmacologically-treated diabetes in the SNDS. But it cannot distinguish type 1 from type 2 diabetes. Differentiating type 1 and type 2 diabetes is crucial in diabetes surveillance, because they carry differences in their prevention, populations at risk, disease natural history, pathophysiology, management and risk of complications.
This article investigates the development of a type 1/type 2 diabetes classification algorithm using artificial intelligence and its application to estimate the prevalence of type 1 and type 2 diabetes in France.
Methods
The final data set comprised all diabetes cases from the CONSTANCES cohort (n = 951). A supervised machine learning method based on eight steps was used: final data set selection, target definition (type 1), coding features, final data set splitting into training and testing data sets, feature selection and training and validation and selection of algorithms. The selected algorithm was applied to SNDS data to estimate the type 1 and type 2 diabetes prevalence among adults 18–70 years of age.
Results
Among the 3481 SNDS features, 14 were selected to train the different algorithms. The final algorithm was a linear discriminant analysis model based on the number of reimbursements for fast-acting insulin, long-acting insulin and biguanides over the previous year (specificity 97% and sensitivity 100%). In 2016, after adjusting for algorithm performance, type 1 and type 2 diabetes prevalence in France was estimated to be 0.3% and 4.4%, respectively.
Conclusion
Our type 1/type 2 classification algorithm was found to perform well and to be applicable to any prescription or medical claims database from other countries. Artificial intelligence opens new possibilities for research and diabetes prevention.
{"title":"Identifying type 1 / type 2 diabetes in medico-administrative database to improve health surveillance, medical research and prevention in diabetes: Algorithm development and application","authors":"Sonsoles Fuentes , Rok Hrzic , Romana Haneef , Sofiane Kab , Emmanuel Cosson , Sandrine Fosse-Edorh","doi":"10.1016/j.deman.2023.100137","DOIUrl":"10.1016/j.deman.2023.100137","url":null,"abstract":"<div><h3>Introduction</h3><p>Big data sources represent an opportunity for diabetes research. One example is the French national health data system (SNDS), gathering information on medical claims of out-of-hospital health care and hospitalizations for the entire French population (66 million). Currently, a validated algorithm based on antidiabetic drug reimbursement is able to identify people with pharmacologically-treated diabetes in the SNDS. But it cannot distinguish type 1 from type 2 diabetes. Differentiating type 1 and type 2 diabetes is crucial in diabetes surveillance, because they carry differences in their prevention, populations at risk, disease natural history, pathophysiology, management and risk of complications.</p><p>This article investigates the development of a type 1/type 2 diabetes classification algorithm using artificial intelligence and its application to estimate the prevalence of type 1 and type 2 diabetes in France.</p></div><div><h3>Methods</h3><p>The final data set comprised all diabetes cases from the CONSTANCES cohort (<em>n</em> = 951). A supervised machine learning method based on eight steps was used: final data set selection, target definition (type 1), coding features, final data set splitting into training and testing data sets, feature selection and training and validation and selection of algorithms. The selected algorithm was applied to SNDS data to estimate the type 1 and type 2 diabetes prevalence among adults 18–70 years of age.</p></div><div><h3>Results</h3><p>Among the 3481 SNDS features, 14 were selected to train the different algorithms. The final algorithm was a linear discriminant analysis model based on the number of reimbursements for fast-acting insulin, long-acting insulin and biguanides over the previous year (specificity 97% and sensitivity 100%). In 2016, after adjusting for algorithm performance, type 1 and type 2 diabetes prevalence in France was estimated to be 0.3% and 4.4%, respectively.</p></div><div><h3>Conclusion</h3><p>Our type 1/type 2 classification algorithm was found to perform well and to be applicable to any prescription or medical claims database from other countries. Artificial intelligence opens new possibilities for research and diabetes prevention.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"10 ","pages":"Article 100137"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45046476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1016/j.deman.2022.100123
Caitlyn Gordon , Barbara Kamel , Lauren McKeon , Danielle Brooks , Rifka Schulman-Rosenbaum
Aims
The study aimed to identify weight-based insulin requirements for dexamethasone-induced hyperglycemia in COVID-19 infection stratified by hemoglobin A1c (HbA1c).
Methods
This retrospective study assessed hospitalized patients ≥ 18 years admitted with COVID-19 and receiving ≥ 1 dose of dexamethasone 6 mG. Daily blood glucose (BG) and insulin doses were collected and organized by HbA1c.
Results
Among 45 patients with available HbA1c, 100% [HbA1c ≥ 7%] and 72% [HbA1c < 7%] developed hyperglycemia (BG ≥180 mG/dL). Median daily insulin (Interquartile Range) (units/kG/day) was 0.03 (0, 0.32) [HbA1c 6–6.9%], 0.1 (0.06, 0.36) [HbA1c 7–7.9%], 0.66 (0.39, 0.69) [HbA1c 8–8.9%], and 0.72 (0.63, 0.78) [HbA1c ≥ 9%]. On day 10 of dexamethasone, when majority of patients were at goal BG, patients required 0.07 (0.01, 0.31) [HbA1c 6–6.9%], 0.59 (0.11, 0.75) [HbA1c 7–7.9%], 1.15 (0.95, 1.35) [HbA1c 8–8.9%], and 1.14 units/kG/day [HbA1c ≥ 9%]. Of 24 patients completing 10 days of dexamethasone, 25% experienced hypoglycemia (BG < 70 mG/dL) upon discontinuation.
Conclusion
Patients with higher HbA1c experienced greater dexamethasone-induced hyperglycemia and required higher insulin doses. Inpatient insulin dosing algorithms should take into consideration baseline HbA1c to avoid delays in achieving normoglycemia.
{"title":"Dexamethasone use and insulin requirements in coronovirus-19 (COVID-19) infection stratified by Hemoglobin A1c","authors":"Caitlyn Gordon , Barbara Kamel , Lauren McKeon , Danielle Brooks , Rifka Schulman-Rosenbaum","doi":"10.1016/j.deman.2022.100123","DOIUrl":"10.1016/j.deman.2022.100123","url":null,"abstract":"<div><h3>Aims</h3><p>The study aimed to identify weight-based insulin requirements for dexamethasone-induced hyperglycemia in COVID-19 infection stratified by hemoglobin A1c (HbA1c).</p></div><div><h3>Methods</h3><p>This retrospective study assessed hospitalized patients ≥ 18 years admitted with COVID-19 and receiving ≥ 1 dose of dexamethasone 6 mG. Daily blood glucose (BG) and insulin doses were collected and organized by HbA1c.</p></div><div><h3>Results</h3><p>Among 45 patients with available HbA1c, 100% [HbA1c ≥ 7%] and 72% [HbA1c < 7%] developed hyperglycemia (BG ≥180 mG/dL). Median daily insulin (Interquartile Range) (units/kG/day) was 0.03 (0, 0.32) [HbA1c 6–6.9%], 0.1 (0.06, 0.36) [HbA1c 7–7.9%], 0.66 (0.39, 0.69) [HbA1c 8–8.9%], and 0.72 (0.63, 0.78) [HbA1c ≥ 9%]. On day 10 of dexamethasone, when majority of patients were at goal BG, patients required 0.07 (0.01, 0.31) [HbA1c 6–6.9%], 0.59 (0.11, 0.75) [HbA1c 7–7.9%], 1.15 (0.95, 1.35) [HbA1c 8–8.9%], and 1.14 units/kG/day [HbA1c ≥ 9%]. Of 24 patients completing 10 days of dexamethasone, 25% experienced hypoglycemia (BG < 70 mG/dL) upon discontinuation.</p></div><div><h3>Conclusion</h3><p>Patients with higher HbA1c experienced greater dexamethasone-induced hyperglycemia and required higher insulin doses. Inpatient insulin dosing algorithms should take into consideration baseline HbA1c to avoid delays in achieving normoglycemia.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"10 ","pages":"Article 100123"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9733297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9795281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1016/j.deman.2023.100129
Elena Putula , Heini Huhtala , Sini Vanhamäki , Tiina Laatikainen , Aapo Tahkola , Päivi Hannula , Saara Metso
Aims
To assess the prognosis and risk factors for diabetic ketoacidosis (DKA) in Tampere University Hospital (Tays) in a retrospective case-control study.
Methods
All 282 patients (age ≥15 years) treated for DKA in Tays during the period 2014–2020 were included. A total of 846 controls adjusted for age, gender, diabetes type and municipality, and without any DKA during follow-up were collected from the Finnish National Diabetes Registry. HbA1c, mental and behavioural disorders, and mortality obtained from the Finnish National Diabetes Registry were compared between patients with and without DKA.
Results
Patients’ median age was 36 years. Ten percent of the patients with DKA died during the median follow-up time of three years. Mortality rate was sixfold higher in patients with DKA than among the controls (OR 6.28; 95% CI 3.17–12.42). Patients with DKA had higher rates of substance abuse (OR 4.68; 95% CI 3.23–6.78) and depression (OR 2.24; 95% CI 1.58–3.18), and higher median HbA1c levels (84 vs. 61 mmol/mol, p < 0.001). Nineteen percent of the DKA patients (n = 53) had recurrent DKA.
Conclusions
DKA is a strong indicator for premature death. Poor glycaemic control, depression and substance abuse are risk factors for DKA.
目的通过回顾性病例对照研究,探讨坦佩雷大学医院糖尿病酮症酸中毒(DKA)患者的预后及危险因素。方法纳入2014-2020年期间在Tays接受DKA治疗的282例患者(年龄≥15岁)。从芬兰国家糖尿病登记处收集了846名对照者,根据年龄、性别、糖尿病类型和所在城市进行了调整,随访期间没有任何DKA。从芬兰国家糖尿病登记处获得的HbA1c、精神和行为障碍以及死亡率在有和没有DKA的患者之间进行了比较。结果患者年龄中位数为36岁。10%的DKA患者在平均3年的随访期间死亡。DKA患者的死亡率是对照组的6倍(OR 6.28;95% ci 3.17-12.42)。DKA患者有较高的药物滥用率(OR 4.68;95% CI 3.23-6.78)和抑郁(OR 2.24;95% CI 1.58-3.18), HbA1c水平中位数较高(84比61 mmol/mol, p <0.001)。19%的DKA患者(53例)有复发性DKA。结论sdka是早期死亡的有力指标。血糖控制不良、抑郁和药物滥用是DKA的危险因素。
{"title":"Clinical characteristics and prognoses of patients with diabetic ketoacidosis in Finland","authors":"Elena Putula , Heini Huhtala , Sini Vanhamäki , Tiina Laatikainen , Aapo Tahkola , Päivi Hannula , Saara Metso","doi":"10.1016/j.deman.2023.100129","DOIUrl":"10.1016/j.deman.2023.100129","url":null,"abstract":"<div><h3>Aims</h3><p>To assess the prognosis and risk factors for diabetic ketoacidosis (DKA) in Tampere University Hospital (Tays) in a retrospective case-control study.</p></div><div><h3>Methods</h3><p>All 282 patients (age ≥15 years) treated for DKA in Tays during the period 2014–2020 were included. A total of 846 controls adjusted for age, gender, diabetes type and municipality, and without any DKA during follow-up were collected from the Finnish National Diabetes Registry. HbA1c, mental and behavioural disorders, and mortality obtained from the Finnish National Diabetes Registry were compared between patients with and without DKA.</p></div><div><h3>Results</h3><p>Patients’ median age was 36 years. Ten percent of the patients with DKA died during the median follow-up time of three years. Mortality rate was sixfold higher in patients with DKA than among the controls (OR 6.28; 95% CI 3.17–12.42). Patients with DKA had higher rates of substance abuse (OR 4.68; 95% CI 3.23–6.78) and depression (OR 2.24; 95% CI 1.58–3.18), and higher median HbA1c levels (84 vs. 61 mmol/mol, <em>p</em> < 0.001). Nineteen percent of the DKA patients (<em>n</em> = 53) had recurrent DKA.</p></div><div><h3>Conclusions</h3><p>DKA is a strong indicator for premature death. Poor glycaemic control, depression and substance abuse are risk factors for DKA.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"10 ","pages":"Article 100129"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45497567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1016/j.deman.2023.100136
Li Chang Ang , Yong Mong Bee , Su-Yen Goh , Ming Ming Teh
Background
Gold and Clarke questionnaire are originally developed to assess impaired awareness of hypoglycaemia (IAH) in type 1 diabetes. Present study examined the similarities and differences between the two questionnaires when administered to insulin-treated type 2 diabetes patients.
Methods
A total of 153 insulin-treated type 2 diabetes patients with mean age of 61.0±9.4 years and mean HbA1c of 8.4±1.5% completed questionnaire in diabetes outpatient clinics of tertiary-care hospital. Factor analysis was conducted to examine the psychometric properties of Clarke questionnaire. Spearman's correlation was used to examine convergent validity of Clarke questionnaire with Gold method.
Results
Bifactorial structure for Clarke questionnaire was identified, namely Awareness of Hypoglycaemia (Factor 1) and Experience of Hypoglycaemia (Factor 2). Clarke Factor 1 correlated strongly with Gold scores (rs=0.77, p<0.001), and yielded 22.9% prevalence of IAH using cut-off score of ≥2.5, which is comparable to Gold method of 19.6%.
Conclusions
Gold single-item questionnaire assesses hypoglycaemia awareness only while Clarke questionnaire assesses both hypoglycaemia awareness and severe hypoglycaemia events. There is a high degree of convergence between Gold and Clarke in hypoglycaemia awareness assessment among insulin-treated type 2 diabetes. Hence, these two questionnaires are similar but not interchangeable due to bifactorial nature of Clarke questionnaire.
{"title":"New insights into the currently available questionnaire for assessing impaired awareness of hypoglycaemia (IAH) among insulin-treated type 2 diabetes- A key risk factor for hypoglycaemia","authors":"Li Chang Ang , Yong Mong Bee , Su-Yen Goh , Ming Ming Teh","doi":"10.1016/j.deman.2023.100136","DOIUrl":"10.1016/j.deman.2023.100136","url":null,"abstract":"<div><h3>Background</h3><p>Gold and Clarke questionnaire are originally developed to assess impaired awareness of hypoglycaemia (IAH) in type 1 diabetes. Present study examined the similarities and differences between the two questionnaires when administered to insulin-treated type 2 diabetes patients.</p></div><div><h3>Methods</h3><p>A total of 153 insulin-treated type 2 diabetes patients with mean age of 61.0±9.4 years and mean HbA1c of 8.4±1.5% completed questionnaire in diabetes outpatient clinics of tertiary-care hospital. Factor analysis was conducted to examine the psychometric properties of Clarke questionnaire. Spearman's correlation was used to examine convergent validity of Clarke questionnaire with Gold method.</p></div><div><h3>Results</h3><p>Bifactorial structure for Clarke questionnaire was identified, namely <em>Awareness of Hypoglycaemia</em> (Factor 1) and <em>Experience of Hypoglycaemia</em> (Factor 2). Clarke Factor 1 correlated strongly with Gold scores (r<sub>s</sub>=0.77, p<0.001), and yielded 22.9% prevalence of IAH using cut-off score of ≥2.5, which is comparable to Gold method of 19.6%.</p></div><div><h3>Conclusions</h3><p>Gold single-item questionnaire assesses hypoglycaemia awareness only while Clarke questionnaire assesses both hypoglycaemia awareness and severe hypoglycaemia events. There is a high degree of convergence between Gold and Clarke in hypoglycaemia awareness assessment among insulin-treated type 2 diabetes. Hence, these two questionnaires are similar but not interchangeable due to bifactorial nature of Clarke questionnaire.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"10 ","pages":"Article 100136"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43534366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-02-01DOI: 10.1016/j.deman.2023.100135
A. Scheen
{"title":"Cardiovascular and renal outcomes with SGLT2 inhibitors: real-life observational studies in older patients with type 2 diabetes","authors":"A. Scheen","doi":"10.1016/j.deman.2023.100135","DOIUrl":"https://doi.org/10.1016/j.deman.2023.100135","url":null,"abstract":"","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54176927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1016/j.deman.2022.100120
Emmanuel O. Olorunsola , Imo E. Udoh , Marvelene B. Ekott , Mfonobong F. Alozie , Koofreh G. Davies
Background
Many works are ongoing with the aim of obtaining a more convenient way than the parenteral injection for administering insulin.
Purpose
To review the biopharmaceutics and clinical outcomes of the various emerging dosage forms of insulin so as to identify the promising formulations.
Method
A systematic literature search with analysis was carried out to obtain information on the biopharmaceutics and clinical outcomes of the emerging dosage forms.
Results
Intraperitoneal insulin was found to be characterized by direct drug delivery through the portal vein to the liver having bioavailability of 60%, but its clinical application is limited by the high risk of infection. The bioavailability of transdermal insulin has been enhanced using electrical, mechanical and physical techniques; and such formulations could achieve up to 39.5% blood glucose reduction. Oral insulin, known to be the most convenient, has its bioavailability limited to 1% by enzymatic degradation and poor absorption. Its challenges however, have been addressed by various interventions to achieve different levels of bioavailability up to 73.1%. Buccal insulin has shown potentials in managing postprandial hyperglycaemia without posing hypoglycaemic risk but its clinical applicability has not been established; whereas the long transit time, lower levels of peptidases and incorporation of permeation-enhancers have been shown to be responsible for the good treatment outcome of colon-targeted insulin. Rectal insulin with bioavailability of 11% has been shown to be considerably safe but not cost-effective while the ocular insulin is limited by poor absorption. Nasal tolerance and high rate of treatment failures were shown to be limiting intranasal insulin while the pulmonary insulin is being limited by peripheral drug retention and insulin resistance.
Conclusion
The biopharmaceutical profiles and clinical outcomes of transdermal, oral and colon-targeted insulin are superior to those of the other dosage forms. Further research works could be done towards the full development of these promising formulations.
{"title":"Biopharmaceutics and clinical outcomes of emerging dosage forms of insulin: A systematic review","authors":"Emmanuel O. Olorunsola , Imo E. Udoh , Marvelene B. Ekott , Mfonobong F. Alozie , Koofreh G. Davies","doi":"10.1016/j.deman.2022.100120","DOIUrl":"10.1016/j.deman.2022.100120","url":null,"abstract":"<div><h3>Background</h3><p>Many works are ongoing with the aim of obtaining a more convenient way than the parenteral injection for administering insulin.</p></div><div><h3>Purpose</h3><p>To review the biopharmaceutics and clinical outcomes of the various emerging dosage forms of insulin so as to identify the promising formulations.</p></div><div><h3>Method</h3><p>A systematic literature search with analysis was carried out to obtain information on the biopharmaceutics and clinical outcomes of the emerging dosage forms.</p></div><div><h3>Results</h3><p>Intraperitoneal insulin was found to be characterized by direct drug delivery through the portal vein to the liver having bioavailability of 60%, but its clinical application is limited by the high risk of infection. The bioavailability of transdermal insulin has been enhanced using electrical, mechanical and physical techniques; and such formulations could achieve up to 39.5% blood glucose reduction. Oral insulin, known to be the most convenient, has its bioavailability limited to 1% by enzymatic degradation and poor absorption. Its challenges however, have been addressed by various interventions to achieve different levels of bioavailability up to 73.1%. Buccal insulin has shown potentials in managing postprandial hyperglycaemia without posing hypoglycaemic risk but its clinical applicability has not been established; whereas the long transit time, lower levels of peptidases and incorporation of permeation-enhancers have been shown to be responsible for the good treatment outcome of colon-targeted insulin. Rectal insulin with bioavailability of 11% has been shown to be considerably safe but not cost-effective while the ocular insulin is limited by poor absorption. Nasal tolerance and high rate of treatment failures were shown to be limiting intranasal insulin while the pulmonary insulin is being limited by peripheral drug retention and insulin resistance.</p></div><div><h3>Conclusion</h3><p>The biopharmaceutical profiles and clinical outcomes of transdermal, oral and colon-targeted insulin are superior to those of the other dosage forms. Further research works could be done towards the full development of these promising formulations.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"9 ","pages":"Article 100120"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49198130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1016/j.deman.2022.100112
Francis Xavier Kasujja , Fred Nuwaha , Elizabeth Kiracho Ekirapa , Ronald Kusolo , Roy William Mayega
Background
Malaria and haemolysis have been linked to a preponderance of altered glycaemic indices. This study set out to estimate the association between asymptomatic malaria and the Fasting Plasma Glucose (FPG), glycated haemoglobin (HBA1c) and Oral Glucose Tolerance (OGT) tests.
Methods
A cross-sectional survey was conducted at a general hospital in eastern Uganda. Eligible participants were patients aged 30–75 years, seeking care at the outpatient department, of unknown diabetes status. Participants were tested for FPG, OGT and HBA1c tests. Multiple linear regression and ROC curve analysis were conducted for the three tests.
Results
A total of 504 participants were enrolled on the study, of whom 78.4% (395) were female. After adjusting for age, sex, and BMI, individuals with asymptomatic malaria had lower average HBA1c [-5 mmol/mol (95% CI, -7 -2) and OGT tests levels [-1.75 mmol/l (-2.6, -0.8)]. The optimal cut-off points for diabetes among individuals with asymptomatic malaria were lower for the HBA1c test [6.5% (47 mmol/mol) versus 6.6% (49 mmol/mol), respectively] but higher for the FPG test (6.6 mmol/l versus 6.2 mmol/l, respectively).
Conclusions
These findings may have implications for diabetes screening in malaria-endemic settings.
{"title":"The association between asymptomatic malaria and blood glucose among outpatients in a rural low-income setting","authors":"Francis Xavier Kasujja , Fred Nuwaha , Elizabeth Kiracho Ekirapa , Ronald Kusolo , Roy William Mayega","doi":"10.1016/j.deman.2022.100112","DOIUrl":"https://doi.org/10.1016/j.deman.2022.100112","url":null,"abstract":"<div><h3>Background</h3><p>Malaria and haemolysis have been linked to a preponderance of altered glycaemic indices. This study set out to estimate the association between asymptomatic malaria and the Fasting Plasma Glucose (FPG), glycated haemoglobin (HBA1c) and Oral Glucose Tolerance (OGT) tests.</p></div><div><h3>Methods</h3><p>A cross-sectional survey was conducted at a general hospital in eastern Uganda. Eligible participants were patients aged 30–75 years, seeking care at the outpatient department, of unknown diabetes status. Participants were tested for FPG, OGT and HBA1c tests. Multiple linear regression and ROC curve analysis were conducted for the three tests.</p></div><div><h3>Results</h3><p>A total of 504 participants were enrolled on the study, of whom 78.4% (395) were female. After adjusting for age, sex, and BMI, individuals with asymptomatic malaria had lower average HBA1c [-5 mmol/mol (95% CI, -7 -2) and OGT tests levels [-1.75 mmol/l (-2.6, -0.8)]. The optimal cut-off points for diabetes among individuals with asymptomatic malaria were lower for the HBA1c test [6.5% (47 mmol/mol) versus 6.6% (49 mmol/mol), respectively] but higher for the FPG test (6.6 mmol/l versus 6.2 mmol/l, respectively).</p></div><div><h3>Conclusions</h3><p>These findings may have implications for diabetes screening in malaria-endemic settings.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"9 ","pages":"Article 100112"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49759593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1016/j.deman.2022.100109
Yuta Ishikawa , Emma M. Laing , Alex K. Anderson , Donglan Zhang , Joseph M. Kindler , Rupal Trivedi-Kapoor , Elisabeth L. P. Sattler
Aims
The objective of the study was to compare screening performances of HbA1c, fasting plasma glucose (FPG), and two-hour plasma glucose (2hPG) in heart failure (HF) patients.
Methods
We included 237 HF patients aged >20 years without history of diabetes, using National Health and Nutrition Examination Survey data (2005–2016). American Diabetes Association diabetes screening criteria were used: (1) HbA1c ≥6.5%, (2) FPG ≥126 mg/dL, and (3) 2hPG ≥200 mg/dL. Sensitivity, specificity, predictive values, and Receiver Operating Characteristic (ROC) curves for HbA1c and FPG were examined against reference methods.
Results
N = 50 patients (20.5%) met at least 1 of 3 clinical criteria for diabetes. 2hPG alone identified 70.5% of patients, whereas HbA1c alone identified only 27.0% of patients. Sensitivity and specificity using a HbA1c cutoff at ≥6.5% were 24.4% and 97.6%, respectively. The Youden's J statistic for HbA1c was maximized at 6.1%. The area under the ROC curve of HbA1c against 2hPG was significantly lower compared to FPG (0.79, 95% CI 0.70-0.88; 0.89, 95% CI 0.84-0.94, respectively; p = 0.04).
Conclusions
Blood glucose criteria are more sensitive than HbA1c when screening HF patients for diabetes. Future studies should test performance of a HbA1c cutoff at 6.1% when FPG or 2hPG cannot be completed.
目的:本研究的目的是比较心力衰竭(HF)患者HbA1c、空腹血糖(FPG)和两小时血糖(2hPG)的筛查性能。方法采用2005-2016年全国健康与营养调查(National Health and Nutrition Survey)资料,选取年龄20岁、无糖尿病史的HF患者237例。采用美国糖尿病协会糖尿病筛查标准:(1)HbA1c≥6.5%,(2)FPG≥126 mg/dL, (3) 2hPG≥200 mg/dL。对照参考方法检验HbA1c和FPG的敏感性、特异性、预测值和受试者工作特征(ROC)曲线。结果50例(20.5%)患者符合糖尿病3项临床标准中的至少1项。单独使用2hPG识别70.5%的患者,而单独使用HbA1c仅识别27.0%的患者。HbA1c临界值≥6.5%的敏感性和特异性分别为24.4%和97.6%。HbA1c的Youden's J统计值达到6.1%。与FPG相比,HbA1c与2hPG的ROC曲线下面积显著降低(0.79,95% CI 0.70-0.88;0.89, 95% CI 0.84-0.94;p = 0.04)。结论在筛选心衰患者糖尿病时,血糖指标比HbA1c指标更敏感。未来的研究应该测试当FPG或2hPG不能完成时HbA1c截止值为6.1%的性能。
{"title":"Comparison of diagnostic screening methods for diabetes in patients with heart failure","authors":"Yuta Ishikawa , Emma M. Laing , Alex K. Anderson , Donglan Zhang , Joseph M. Kindler , Rupal Trivedi-Kapoor , Elisabeth L. P. Sattler","doi":"10.1016/j.deman.2022.100109","DOIUrl":"10.1016/j.deman.2022.100109","url":null,"abstract":"<div><h3>Aims</h3><p>The objective of the study was to compare screening performances of HbA1c, fasting plasma glucose (FPG), and two-hour plasma glucose (2hPG) in heart failure (HF) patients.</p></div><div><h3>Methods</h3><p>We included 237 HF patients aged >20 years without history of diabetes, using National Health and Nutrition Examination Survey data (2005–2016). American Diabetes Association diabetes screening criteria were used: (1) HbA1c ≥6.5%, (2) FPG ≥126 mg/dL, and (3) 2hPG ≥200 mg/dL. Sensitivity, specificity, predictive values, and Receiver Operating Characteristic (ROC) curves for HbA1c and FPG were examined against reference methods.</p></div><div><h3>Results</h3><p><em>N</em> = 50 patients (20.5%) met at least 1 of 3 clinical criteria for diabetes. 2hPG alone identified 70.5% of patients, whereas HbA1c alone identified only 27.0% of patients. Sensitivity and specificity using a HbA1c cutoff at ≥6.5% were 24.4% and 97.6%, respectively. The Youden's J statistic for HbA1c was maximized at 6.1%. The area under the ROC curve of HbA1c against 2hPG was significantly lower compared to FPG (0.79, 95% CI 0.70-0.88; 0.89, 95% CI 0.84-0.94, respectively; <em>p</em> = 0.04).</p></div><div><h3>Conclusions</h3><p>Blood glucose criteria are more sensitive than HbA1c when screening HF patients for diabetes. Future studies should test performance of a HbA1c cutoff at 6.1% when FPG or 2hPG cannot be completed.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"9 ","pages":"Article 100109"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44809850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.1016/j.deman.2022.100114
Jonas F.R. Schaarup , Ravi Aggarwal , Else-Marie Dalsgaard , Kasper Norman , Ole Lindgård Dollerup , Hutan Ashrafian , Daniel R. Witte , Annelli Sandbæk , Adam Hulman
Background
Patients’ acceptance of artificial intelligence (AI) based health-related technologies depend strongly on their perception and trust of AI. This research field has not been studied extensively, especially among people living with diabetes. A large proportion of them frequently use health technologies in their everyday lives to manage their condition, which may make them more prepared to adopt AI-based solutions. Our study aimed to investigate the perception of AI-based solutions in healthcare, and characteristics associated with positive attitudes towards AI among people with and without diabetes.
Methods
An online survey was sent to 12,755 participants in the Health in Central Denmark cohort, including 10 questions and six scenarios related to current technology use, data sharing, and AI. The question on benefits and risks of AI, and the responses to the scenarios were used as outcomes. Multinomial logistic regression was used to examine which characteristics were associated with seeing the benefit of AI over the risks, including diabetes status, age, sex, education, health literacy, the use of wearable devices, and views on data sharing. A similar analysis was conducted on the acceptance of AI-based solutions in healthcare-related scenarios.
Findings
8,420 participants responded to the survey. Most participants (88%) had previously heard about AI. 46% of participants agreed with the statement that the benefits of AI outweigh the risks, while only 2% agreed with the opposite statement, and 30% were unsure. We did not find evidence for a differential opinion by diabetes status. Having diabetes was associated with less openness to replace healthcare professionals by AI-based technologies, although most people were still open to AI if controlled by humans.
Interpretation
Despite the generally positive perception of AI and its benefits to healthcare, human interaction seemed to play an important role in defining positive attitudes to AI across different healthcare scenarios, especially among people with diabetes. This highlights the pressing need for a patient-centered development process of AI-based solutions in the future.
{"title":"Perception of artificial intelligence-based solutions in healthcare among people with and without diabetes: A cross-sectional survey from the health in Central Denmark cohort","authors":"Jonas F.R. Schaarup , Ravi Aggarwal , Else-Marie Dalsgaard , Kasper Norman , Ole Lindgård Dollerup , Hutan Ashrafian , Daniel R. Witte , Annelli Sandbæk , Adam Hulman","doi":"10.1016/j.deman.2022.100114","DOIUrl":"10.1016/j.deman.2022.100114","url":null,"abstract":"<div><h3>Background</h3><p>Patients’ acceptance of artificial intelligence (AI) based health-related technologies depend strongly on their perception and trust of AI. This research field has not been studied extensively, especially among people living with diabetes. A large proportion of them frequently use health technologies in their everyday lives to manage their condition, which may make them more prepared to adopt AI-based solutions. Our study aimed to investigate the perception of AI-based solutions in healthcare, and characteristics associated with positive attitudes towards AI among people with and without diabetes.</p></div><div><h3>Methods</h3><p>An online survey was sent to 12,755 participants in the Health in Central Denmark cohort, including 10 questions and six scenarios related to current technology use, data sharing, and AI. The question on benefits and risks of AI, and the responses to the scenarios were used as outcomes. Multinomial logistic regression was used to examine which characteristics were associated with seeing the benefit of AI over the risks, including diabetes status, age, sex, education, health literacy, the use of wearable devices, and views on data sharing. A similar analysis was conducted on the acceptance of AI-based solutions in healthcare-related scenarios.</p></div><div><h3>Findings</h3><p>8,420 participants responded to the survey. Most participants (88%) had previously heard about AI. 46% of participants agreed with the statement that the benefits of AI outweigh the risks, while only 2% agreed with the opposite statement, and 30% were unsure. We did not find evidence for a differential opinion by diabetes status. Having diabetes was associated with less openness to replace healthcare professionals by AI-based technologies, although most people were still open to AI if controlled by humans.</p></div><div><h3>Interpretation</h3><p>Despite the generally positive perception of AI and its benefits to healthcare, human interaction seemed to play an important role in defining positive attitudes to AI across different healthcare scenarios, especially among people with diabetes. This highlights the pressing need for a patient-centered development process of AI-based solutions in the future.</p></div>","PeriodicalId":72796,"journal":{"name":"Diabetes epidemiology and management","volume":"9 ","pages":"Article 100114"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45634860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}